A Phase 2 Single-Arm Open-Label Extension Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (1311.5)
Phase: PHASE2
Conditions: Psoriatic Arthritis
Sponsor: AbbVie

Risankizumab/ABBV-066
M16-244 Protocol Amendment 1
EudraCT 2016-003113-94
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1.0
Title Page
Clinical Study Protocol M16-244
A Phase 2 Single-Arm Open-Label Extension Study to 
Investigate Safety with Risankizumab in Psoriatic 
Arthritis Subjects Who Have Completed Week 24 
Visit of Study 1311.5
Incorporating Administrative Change 1 and 
Amendment 1
AbbVie Investigational
  Product:
Risankizumab/ABBV-066/previously BI655066
Date:
23 May 2018
Development Phase:
2
Study Design:
This is a single-arm, open-label extension study.
EudraCT Number:
2016-003113-94
Investigator(s):
Multicenter Study:  Investigator information is on file at AbbVie.
Sponsor:
For EU Countries:*
AbbVie Deutschland
GmbH & Co. KG (AbbVie)
Knollstrasse 50
67061 Ludwigshafen
Germany
For Non-EU Countries:
AbbVie
1 North Waukegan Road
Bldg. AP31
North Chicago, IL 60064
USA
Sponsor Contact:
NCT02986373

Risankizumab/ABBV-066
M16-244 Protocol Amendment 1
EudraCT 2016-003113-94
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Emergency Medical
  Contact:
*  The specific contact details of the AbbVie legal/regulatory entity (person) within the relevant country are 
provided within the clinical trial agreement with the Investigator/Institution and in the Clinical Trial 
Application with the Competent Authority.
This study will be conducted in compliance with the protocol, Good Clinical Practice and all other 
applicable regulatory requirements, including the archiving of essential documents.
Confidential Information
No use or disclosure outside AbbVie is permitted without prior written authorization from AbbVie.

Risankizumab/ABBV-066
M16-244 Protocol Amendment 1
EudraCT 2016-003113-94
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1.1
Protocol Amendment:  Summary of Changes
Previous Protocol Versions
Protocol 
Date 
Original
29 August 2016
Administrative Change 1
20 March 2017
The purpose of this amendment is to:
●
Include changes made as a result of Administrative Change 1.
●
Revise inclusion and exclusion criteria to require that women of childbearing 
potential use contraception throughout the study, including 20 weeks after the 
last dose of study drug, and exclude subjects who are pregnant, breastfeeding 
or considering becoming pregnant throughout the study, including 20 weeks 
after the last dose of study drug.
Rationale:  Due to additional data clarifying an extension of the risankizumab 
(t1/2) from 16 to 20 weeks in the risankizumab Investigator's Brochure 
Edition 3.0.  
●
Incorporate addition of a follow-up phone call 20 weeks after last dose of 
study drug. 
Rationale:  Due to additional data clarifying the risankizumab t1/2 from 16 to 
20 weeks in the risankizumab Investigator's Brochure Edition 3.0.  
●
Extend the adverse event (AE) collection period and contraception requirement 
duration from 16 weeks after the last dose of study drug to 20 weeks after the 
last dose of study drug. 
Rationale:  Due to additional data clarifying the risankizumab t1/2 from 16 to 
20 weeks in the risankizumab Investigator's Brochure Edition 3.0.  
●
Correct errors in Section 5.4.1 and Appendix J.
●
Update information for study contacts in Section 7.0 and Appendix D.
An itemized list of all changes made to this protocol under this amendment can be found 
in Appendix V.

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M16-244 Protocol Amendment 1
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1.2
Synopsis
AbbVie Inc.
Protocol Number:  M16-244
Name of Study Drug:  Risankizumab/ABBV-066 
(previously known as BI 655066)
Phase of Development:  2
Name of Active Ingredient:  
Risankizumab/ABBV-066
Date of Protocol Synopsis:  23 May 2018
Protocol Title:  A Phase 2, Single-Arm, Open-Label Extension Study to Investigate the Safety with 
Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study 1311.5
Objectives:  
!
Primary objective:
o
Assess the safety and tolerability of risankizumab in psoriatic arthritis (PsA) subjects who 
have completed all doses of study drug and Week 24 visit of Study 1311.5 
!
Secondary objectives:
o
Assess the efficacy of risankizumab in PsA subjects who have completed all doses of study 
drug and Week 24 visit of Study 1311.5.
o
Assess the impact of risankizumab on the inhibition of structural progression in PsA 
subjects who have completed all doses of study drug and Week 24 visit of Study 1311.5.
Investigators:  Multicenter
Study Sites:  Approximately 70 sites globally
Study Population:  Adult female and male PsA subjects who have completed all doses of study drug and 
the Week 24 visit of Study 1311.5, and who have met all of the specified inclusion and none of the 
exclusion criteria.
Number of Subjects to be Enrolled:  Up to 180 subjects will be enrolled in this OLE study.
Methodology:  
This is a 52-week multicenter, single-arm, open-label extension (OLE) study to assess the efficacy, safety 
and tolerability of risankizumab in PsA subjects who have completed all doses of study drug and Week 
24 visit of Study 1311.5 (Phase 2 randomized control trial in PsA subjects, sponsored by Boehringer 
Ingelheim).  The subjects may finish Week 24 visit of Study 1311.5 and take the first dose of 
Study M16-244 on the same day or Study M16-244 start may be delayed up to 8 weeks if needed.  
All subjects will be on risankizumab 150 mg by subcutaneous injection every 12 weeks (q12w) starting at 
Week 0 for 36 weeks in an open-label fashion.  An additional dose of risankizumab 150 mg by 
subcutaneous injection will be made available at the Week 4 visit to subjects who have not achieved a 
protocol defined response (defined as an improvement in tender and swollen joint count of ≥ 20% 
compared with the baseline in Study 1311.5) and the investigator believes that this additional dose may 
be beneficial to the subject.

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M16-244 Protocol Amendment 1
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Diagnosis and Main Criteria for Inclusion/Exclusion:  
Main Inclusion:  
1.
Subjects who have completed all doses of study drug and Week 24 visit of Study 1311.5.
2.
Women of childbearing potential who are sexually active, must agree to use at least one accepted 
method of contraception throughout the study, including 20 weeks after last dose of study drug is 
given.
3.
Women of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1).
4.
Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics 
Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study specific 
procedures.
5.
Subject is judged to be in good health as determined by the Investigator
Main Exclusion:
1.
Female subject who is pregnant, breastfeeding or is considering becoming pregnant during study 
participation, including 20 weeks after the last dose of study drug is given.
2.
Premature discontinuation of the study drug in Study 1311.5 for any reason.
3.
Use of a biologic treatment other than risankizumab since first dose of study drug in Study 1311.5.
4.
Time elapsed is > 8 weeks since the Week 24 visit in Study 1311.5
5.
Active systemic infections during the last 2 weeks (exception:  common cold) prior to randomization, 
as assessed by the investigator.
Investigational Product:
Risankizumab (ABBV-066):  75 mg pre-filled syringe, 90 mg/mL, 
0.83 mL dispensed volume, 0.87 mL fill volume.
Doses:
Risankizumab (ABBV-066):  150 mg administered every 12 weeks for 
36 weeks
Mode of Administration:
Subcutaneous injection
Reference Therapy:
None (Single-arm, Open-Label Extension)
Duration of Treatment:  36 weeks

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Criteria for Evaluation:
Efficacy:
The baseline as defined in Study 1311.5 will be used to derive the efficacy endpoints in this study.
The following endpoints will be assessed at all measured time points:
!
American College of Rheumatology (ACR) 20/50/70 response
!
Change in Tender Joint Count (TJC) and Swollen Joint Count (SJC) as compared to Baseline
!
Change in Health Assessment Questionnaire – Disability Index (HAQ-DI) as compared to 
Baseline
!
Change in Short Form-36 Health Survey (SF-36) as compared to Baseline
!
Change in Dactylitis count as compared to Baseline
!
Change in Leeds Dactylitis Index (LDI) as compared to Baseline
!
Change in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index 
!
Leeds Enthesitis Index (LEI) as compared to Baseline
!
Change in Modified Nail Psoriasis Severity Index (mNAPSI) as compared to Baseline
!
Change in Physician's Global Assessment of Disease Activity (VAS) (PhGA) as compared to 
Baseline
!
Change in Patient's Assessment of PsA Pain Intensity (VAS) as compared to Baseline
!
Change in Patient's Global Assessment of Disease Activity (PtGA) as compared to Baseline
!
Change in High sensitivity C-Reactive Protein (hsCRP) as compared to Baseline
!
Minimal disease activity (MDA)
!
Change in Disease Activity Score in 28 joints using hsCRP(DAS28-hsCRP) as compared to 
Baseline
!
Psoriasis (PsO) endpoints assessed in subjects with a ≥ 3% baseline PsO body surface area 
(BSA):
o
PASI 75 and PASI 90 response
o
Static Physician Global Assessment (sPGA) clear or almost clear (0 or 1)
!
European League Against Rheumatism (EULAR) response
!
Change in Psoriatic Arthritis Response Criteria (PsARC) as compared to Baseline
!
Presence of dactylitis (yes/no)
!
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) as compared 
to baseline
!
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (in subjects with 
baseline inflammatory spondylitis, based on investigator judgment, in Study 1311.5) as 
compared to baseline
!
Change in Modified total Sharp Score (mTSS) at Weeks 24 and 48

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Criteria for Evaluation (Continued):
Pharmacokinetic and Immunogenicity:
Risankizumab plasma concentrations will be determined.  Pharmacokinetics (PK) and anti-drug 
antibodies (ADA) data may be combined with data from other studies and analyzed using a mixed-effects 
modeling approach.  This analysis will estimate the population central value and the empirical Bayesian 
estimates of the individual values for risankizumab apparent clearance (CL/F) and volume of distribution 
(Vss/F).  Additional parameters may be estimated if useful in the interpretation of the data.
Multiple measurements of ADA for risankizumab will be collected for each subject during the treatment 
period and the follow-up visit.  The percentage of subjects with ADA will be calculated.  As appropriate, 
the effect of ADA on risankizumab PK and efficacy will be explored.
Pharmacodynamic:
Pharmacokinetic/pharmacodynamics relationship will be explored across several clinical laboratory 
endpoints.
Safety:
Safety and tolerability evaluations include adverse event monitoring, physical examinations, vital sign 
measurements, and clinical laboratory testing (hematology, chemistry, and urinalysis).  Toxicity 
management guidelines are provided within the study protocol.
Statistical Methods:
Efficacy:
The baseline, as defined in Study 1311.5, will be used to derive the efficacy endpoints in this study.  
The proportion of subjects with ACR20/50/70, PASI75/90, sPGA (0/1), EULAR response, presence of 
dactylitis (yes/no), and MDA (yes/no), will be summarized with 95% confidence intervals by visit and 
plotted over time.
Change from the baseline will be summarized by visit with descriptive statistics for all continuous 
variables including each individual component of ACR response (TJC, SJC, PhGA, Patient's Assessment 
of PsA Pain Intensity, PtGA, HAQ-DI and hsCRP), DAS28-hsCRP, PASI, sPGA, PsARC, Dactylitis 
Count, LDI, LEI, SPARCC Enthesitis Index, BASDAI mNAPSI, and mTSS using x-ray.  Change from 
baseline will also be summarized by visit with descriptive statistics for measures of quality of life, 
function and work such as SF-36, and FACIT-F.
Safety:
All subjects who receive at least one dose of risankizumab during the conduct of this study will be 
included in the safety analysis.  Incidence of adverse events, serious adverse events, premature 
discontinuation, and changes from baseline in vital signs, physical examination results and clinical 
laboratory values will be analyzed.  Treatment-emergent adverse events will be tabulated by Medical 
Dictionary for Regulatory Activities (MedDRA) system organ class and by Preferred Term (PT).  Mean 
change from baseline, as defined in Study 1311.5 for laboratory and vital signs data will be summarized 
by visit.

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1.3
List of Abbreviations and Definition of Terms
Abbreviations
ACR
American College of Rheumatology
ADA
Anti-Drug Antibody
AE
Adverse Event
AESI
Adverse Event of Special Interest
ALT
Alanine Aminotransferase
AST
Aspartate Aminotransferase
ATEMS
AbbVie Temperature Excursion Management System
BASDAI
Bath Ankylosing Spondylitis Disease Activity Index
BI
Boehringer Ingelheim
BSA
Body Surface Area
CA
Competent Authority
CCVT
Cardiovascular, Cerebrovascular and Thrombosis
CD
Crohn's Disease
CRA
Clinical Research Associate
DAS28
Disease Activity Score in 28 joints
DILI
Drug Induced Liver Injury
DIP
Distal Interphalangeal
DMARDs
Disease-Modifying Anti-rheumatic Drugs
DMC
Data Monitoring Committee
DN
Double Negative
DNA
Deoxyribonucleic Acid
ECG
Electrocardiogram
eCRF
Electronic Case Report Form
eGFR
Estimated Glomerular Filtration Rate
EOS
End Of Study
EOT 
End Of Treatment
EudraCT
European Clinical Trials Database
EULAR
European League Against Rheumatism
FACIT-F
Functional Assessment of Chronic Illness Therapy-Fatigue
FDA
Food and Drug Administration
GCP
Good Clinical Practice

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HAQ-DI
Health Assessment Questionnaire-Disability Index
HIV
Human Immunodeficiency Virus
hsCRP
High sensitivity C-Reactive Protein
IB
Investigator's Brochure
IC50
Half-maximal Inhibition
ICH
International Conference on Harmonization
IEC
Independent Ethics Committee
IFN
Interferon
IgG
Immunoglobulin G
IGRA
Interferon Gamma Release Assay 
IL
Interleukin
ILCs
Innate Lymphoid Cells
IMP
Investigational Medicinal Product
IP
Investigational Product
IP
Interphalangeal
IRB
Institutional Review Board
IRT
Interactive Response System
ISF
Investigator Site File
i.v.
Intravenous
LDI
Leeds Dactylitis Index
LEI
Leeds Enthesitis Index
mAb
monoclonal Antibody
MACE
Major Adverse Cardiovascular Event 
MCP
Metacarpalphalangeal
MDA
Minimal Disease Activity
MedDRA
Medical Dictionary for Regulatory Activities
mNAPSI
Modified Nail Psoriasis Severity Index
MRI
Magnetic Resonance Imaging
mTSS
Modified Total Sharp Score
MTX
Methotrexate
NK
Natural Killer
nM
Nanomolar
NOAEL
No Observed Adverse Effect Level
NSAIDs
Non-Steroidal Anti-Inflammatory Drugs

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OMERACT
Outcome Measures in Rheumatology
OLE
Open Label Extension
PASI
Psoriasis Area and Severity Index
PD
Pharmacodynamic
PhGA
Physician's Global Assessment of Disease Activity
PI
Principal Investigator
PIP
Proximal Interpalangeal
PK
Pharmacokinetic
pM
Picomolar
POR
Proof of Receipt
PPD
Purified Protein Derivative
PRN
(Pro re nata) when necessary
PsA
Psoriatic Arthritis
PsARC
Psoriatic Arthritis Response Criteria
PsO
Psoriasis
PT
Preferred Term
PtGA
Patient's Global Assessment of Disease Activity
PUVA
Psoralen and ultraviolet A
RCT
Randomized Control Trial
RCTC
Rheumatology Common Toxicity Criteria
REP
Residual Effect Period
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
s.c.
subcutaneous
SF-36
Short Form-36 Health Survey
SJC
Swollen Joint Count(s)
SPARCC
Spondyloarthritis Research Consortium of Canada
sPGA
Static Physician Global Assessment
SOC
System Organ Class
t1/2
Half-life
SUSAR
Suspected Unexpected Serious Adverse Reaction
TB
Tuberculosis
TEAE
Treatment Emergent Adverse Events
TJC
Tender Joint Count(s)

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TNF
Tumor necrosis factor
TNFi
Tumor necrosis factor inhibitor(s)
UV(A/B)
Ultraviolet (A/B)
VAS
Visual Analog Scale
W
Week
WBC
White Blood Count
WOCBP
Women of child-bearing potential
Pharmacokinetic and Statistical Abbreviations
AUC
Area under the plasma concentration-time curve
CL/F
Apparent clearance
Cmax
Maximum observed plasma concentration
Ctrough
Trough concentration
LOCF
Last observation carried forward
NRI
Non-responder imputation
OC
Observed cases
Tmax
Time to maximum observed plasma concentration
Vss/F
Volume of distribution

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2.0
Table of Contents
1.0
Title Page ...............................................................................1
1.1
Protocol Amendment:  Summary of Changes ......................................... 3
1.2
Synopsis................................................................................................. 4
1.3
List of Abbreviations and Definition of Terms........................................ 8
2.0
Table of Contents ................................................................ 12
3.0
Introduction......................................................................... 17
3.1
Medical Background ............................................................................ 17
3.2
Drug Profile ......................................................................................... 18
3.3
Differences Statement .......................................................................... 21
3.4
Benefits and Risks................................................................................ 21
4.0
Study Objective ................................................................... 23
4.1
Primary Objective ................................................................................ 23
4.2
Secondary Objectives ........................................................................... 23
5.0
Investigational Plan.............................................................24
5.1
Overall Study Design and Plan:  Description ........................................ 24
5.2
Selection of Study Population............................................................... 26
5.2.1
Inclusion Criteria.................................................................................. 26
5.2.2
Exclusion Criteria................................................................................. 27
5.2.3
Prior and Concomitant Therapy............................................................ 29
5.2.3.1
Prior Therapy ....................................................................................... 30
5.2.3.2
Concomitant Therapy........................................................................... 30
5.2.3.3
Prohibited Therapy............................................................................... 31
5.2.4
Contraception Recommendations and Pregnancy.................................. 32
5.3
Efficacy and Safety Assessments/Variables.......................................... 34
5.3.1
Efficacy and Safety Measurements Assessed........................................ 34
5.3.1.1
Study Procedures.................................................................................. 34
5.3.2
Drug Concentration Measurements....................................................... 44
5.3.2.1
Collection of Samples for Analysis....................................................... 44
5.3.2.2
Handling/Processing of Samples........................................................... 45
5.3.2.3
Disposition of Samples......................................................................... 45
5.3.2.4
Measurement Methods ......................................................................... 46

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5.3.3
Efficacy Variables................................................................................ 46
5.3.3.1
Primary Endpoint(s) ............................................................................. 46
5.3.3.2
Secondary Endpoint(s) ......................................................................... 46
5.3.3.3
Further Endpoint(s) .............................................................................. 46
5.3.4
Safety Variables ................................................................................... 48
5.3.5
Pharmacokinetic Variables ................................................................... 48
5.4
Removal of Subjects from Therapy or Assessment ............................... 48
5.4.1
Discontinuation of Individual Subjects ................................................. 48
5.4.2
Discontinuation of Entire Study............................................................ 50
5.5
Treatments ........................................................................................... 51
5.5.1
Treatments Administered...................................................................... 51
5.5.2
Identity of Investigational Product........................................................ 52
5.5.2.1
Packaging and Labeling........................................................................ 52
5.5.2.2
Storage and Disposition of Study Drug(s)............................................. 53
5.5.3
Method of Assigning Subjects to Treatment Groups ............................. 53
5.5.4
Selection and Timing of Dose for Each Subject .................................... 53
5.5.5
Treatment Compliance ......................................................................... 54
5.5.6
Drug Accountability ............................................................................. 54
5.6
Discussion and Justification of Study Design........................................ 55
5.6.1
Discussion of Study Design and Choice of Control Groups .................. 55
5.6.2
Appropriateness of Measurements........................................................ 56
5.6.3
Suitability of Subject Population .......................................................... 56
5.6.4
Selection of Doses in the Study ............................................................ 56
6.0
Complaints........................................................................... 57
6.1
Medical Complaints ............................................................................. 58
6.1.1
Definitions ........................................................................................... 58
6.1.1.1
Adverse Event...................................................................................... 58
6.1.1.2
Serious Adverse Events........................................................................ 59
6.1.1.3
Adverse Events of Special Interest (AESI)............................................ 60
6.1.2
Adverse Event Severity ........................................................................ 62
6.1.3
Relationship to Study Drug................................................................... 62
6.1.4
Adverse Event Collection Period.......................................................... 63
6.1.5
Adverse Event Reporting...................................................................... 63

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6.1.6
Pregnancy............................................................................................. 65
6.2
Product Complaint................................................................................ 66
6.2.1
Definition............................................................................................. 66
6.2.2
Reporting ............................................................................................. 66
7.0
Protocol Deviations ............................................................. 67
8.0
Statistical Methods and Determination of Sample 
Size ....................................................................................... 68
8.1
Statistical and Analytical Plans............................................................. 68
8.1.1
Datasets for Analysis............................................................................ 68
8.1.2
Subject Accountability ......................................................................... 68
8.1.3
Demographic and Baseline Characteristics ........................................... 68
8.1.4
Subject Disposition and Study Drug Exposure...................................... 68
8.1.4.1
Subject Disposition............................................................................... 68
8.1.4.2
Study Drug Exposure ........................................................................... 69
8.1.5
Efficacy Analysis ................................................................................. 69
8.1.5.1
Efficacy Variable.................................................................................. 69
8.1.5.2
Efficacy Analysis ................................................................................. 70
8.1.5.3
Multiple Comparisons .......................................................................... 70
8.1.6
Safety Analysis..................................................................................... 70
8.1.6.1
General Considerations......................................................................... 70
8.1.6.2
Analysis of Adverse Events.................................................................. 71
8.1.6.2.1
Treatment-Emergent Adverse Events.................................................... 71
8.1.6.2.2
Serious Adverse Events and Death ....................................................... 72
8.1.6.3
Analysis of Laboratory and Vital Signs ................................................ 72
8.1.7
Pharmacokinectic and Exposure-Response Analysis............................. 72
8.1.8
Interim Analysis................................................................................... 74
8.1.9
Data Monitoring Committee................................................................. 74
8.1.10
CCVT Adjudication Committee ........................................................... 74
8.2
Determination of Sample Size .............................................................. 75
9.0
Ethics.................................................................................... 75
9.1
Independent Ethics Committee (IEC) or Institutional Review 
Board (IRB) ......................................................................................... 75
9.2
Ethical Conduct of the Study................................................................ 76

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9.3
Subject Information and Consent.......................................................... 76
9.3.1
Informed Consent Form and Explanatory Material ............................... 76
10.0
Source Documents and Case Report Form 
Completion ..........................................................................77
10.1
Source Documents................................................................................ 77
10.2
Case Report Forms............................................................................... 77
11.0
Data Quality Assurance ...................................................... 79
12.0
Use of Information ..............................................................79
13.0
Completion of the Study ..................................................... 80
14.0
Investigator's Agreement....................................................82
15.0
Reference List......................................................................83
15.1
Published References............................................................................ 83
15.2
Unpublished References....................................................................... 86
List of Tables
Table 1.
Clinical Laboratory Tests ..................................................................... 39
Table 2.
Identity of Investigational Product........................................................ 52
Table 3.
sPGA Rating Scale for Overall Psoriatic Disease.................................110
Table 4.
Hands (in cm)......................................................................................111
Table 5.
Feet (in cm).........................................................................................112
List of Figures
Figure 1.
Reduction in Pain – Rates of Subjects with > 50% Reduction in 
Pain-VAS Score from Baseline at Weeks 4, 12, and 24......................... 20
Figure 2.
Study M16-244 Study Design............................................................... 26
Figure 3.
Adverse Event Collection..................................................................... 63
List of Appendices
Appendix A.
Responsibilities of the Clinical Investigator.......................................... 88
Appendix B.
List of Protocol Signatories .................................................................. 90

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Appendix C.
Study Activities.................................................................................... 91
Appendix D.
Local Requirements.............................................................................. 96
Appendix E.
Joint Assessment .................................................................................104
Appendix F.
PASI SCORE Definitions and Use ......................................................107
Appendix G.
Static Physician Global Assessment (sPGA)........................................108
Appendix H.
Leeds Dactylitis Index (LDI)...............................................................111
Appendix I.
Leeds Enthesitis Index (LEI) ...............................................................113
Appendix J.
Spondyloarthritis Research Consortium of Canada (SPARCC) 
Enthesitis Index...................................................................................114
Appendix K.
mNAPSI – Modified Nail Psoriasis Severity Index..............................115
Appendix L.
ACR Response Criteria .......................................................................118
Appendix M.
Physician's Global Assessment of Disease Activity (PhGA) ................119
Appendix N.
Minimal Disease Activity....................................................................120
Appendix O.
DAS28 – hsCRP..................................................................................121
Appendix P.
EULAR Response Criteria...................................................................122
Appendix Q.
PsARC Response.................................................................................123
Appendix R.
Patient Reported Outcomes .................................................................124
Appendix S.
Rheumatology Common Toxicity Criteria v.2.0 Example....................127
Appendix T.
Class VI and Class VII Topical Corticosteroid Examples.....................138
Appendix U.
Follow-up Phone Call..........................................................................139
Appendix V.
Protocol Amendment:  List of Changes ...............................................141

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3.0
Introduction
3.1
Medical Background
Psoriatic Arthritis (PsA) is a chronic seronegative spondyloarthritis characterized by 
peripheral synovitis, enthesitis, dactylitis and spondylitis.12,24  PsA is mostly associated 
with Psoriasis (PsO) and nail involvement.18  Prevalence estimates for PsA among PsO 
patients vary across studies, ranging from 6 to 30%,15,16 with PsA affecting about 0.3 to 
1% of the global population, equally across men and women.18  The cause of PsA is not 
known, but hereditary factors, infection and physical trauma are frequently referred to as 
potential risk factors.
Although effective treatments for PsA are approved (traditional disease-modifying 
antirheumatic drugs (DMARDs) (e.g., methotrexate (MTX), leflunomide), apremilast, 
tumor necrosis factor inhibitors (TNFi) (certolizumab pegol, adalimumab, etanercept, 
infliximab, golimumab), anti-IL-12/23p40 (ustekinumab), and anti-IL-17 (secukinumab), 
the unmet medical need remains for safer therapy that works more effectively on 
measures of signs and symptoms of PsA and prevention of structural damage.  
Maintenance of efficacy over time, preferably with a new mode of action to provide more 
treatment options to patients who have already failed the currently approved therapies, is 
desirable.
Risankizumab is a humanized monoclonal antibody (mAb) directed against human 
Interleukin 23 (IL-23) that specifically neutralizes this cytokine and prevents binding and 
signaling through the IL-23 receptor, expressed on T helper 17 cells (TH17) cells as well 
as subset of γδ T cells, natural killer (NK) cells, innate lymphoid cells (ILCs) and double 
negative (DN) entheseal-residing T cells.  Risankizumab has a potential for addressing 
some of the unmet needs in PsA.
PsO and PsA share common pathologies based on cellular pathways (T cells/plasmacytoid 
dendritic cells), transcription factors (decreased AP-1), genetic susceptibility loci 
(CARD15/PSORAS1/NOD2, TNF gene polymorphism) and cytokines/other mediators 

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(TNF, type 1 interferon, amphiregulin).20  Pro-inflammatory mediators that act as drivers 
of PsO and PsA are released by a variety of cell types, including innate immune cells, 
adaptive immune cells and resident immune cells.9  Plasmacytoid dendritic cells are found 
in psoriatic skin and psoriatic synovium and activated dendritic cells present antigens and 
produce interferon (IFN)-α and pro-inflammatory mediators, such as IL-12 and IL-23.  
Antigen presented by myeloid dendritic cells to T-cells results in proliferation and 
differentiation into type 1 and type 17 T helper cells, which increase secretion of 
inflammatory cytokines.9,21
The role of the IL-23/IL-17 axis in PsA is well documented in the literature.13  IL-23 is 
expressed in the synovial tissue of patients with PsA.17  Single nucleotide polymorphisms 
in this genetic pathway are related to genetic susceptibility to PsA.14,22  IL-23 has been 
shown to cause enthesitis (one of the key features of PsA) in a rodent model.10  The role 
of IL-23 (through its effect on TH17 cells) has been implied in bone erosion and 
dysregulated bone formation in PsA.  IL-17 can cause cartilage degradation via effects on 
chondrocytes.23  In addition, IL-23 (independent of TH17) activates IL-23R+ entheseal 
resident lymphocyte cell population, which produces IL-22, and can promote entheseal 
and periosteal bone formation.10
3.2
Drug Profile
Risankizumab is a humanized monoclonal antibody (mAb) of the IgG1 subclass directed 
towards IL-23p19.  The antibody has been engineered to reduce Fcγ receptor and 
complement binding, and potential charge heterogeneity.  Risankizumab binds with high 
affinity to human IL-23 and inhibits IL-23 stimulated IL-17 production at IC50
concentrations below 10 pM, as compared with 167 pM for ustekinumab in the same 
system.  Risankizumab does not affect IL-12 at a maximum tested concentration (33 nM) 
and it does not inhibit IL-12 stimulated IFN-γ production.
The toxicology data suggest risankizumab can be safely administered to humans, as 
supported by chronic administration to monkeys for up to 26 weeks.  The monkey was 
identified as the most relevant toxicology species with a NOAEL (no observed adverse 

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effect level) of 50 mg/kg/dose (highest tested dose), corresponding to an exposure 
(combined sex) of 677 μg/mL for the Cmax and 86,250 μg•h/mL for AUC0-168, 
respectively.
Proof of clinical concept for risankizumab through IL-23/IL-17 pathway was 
demonstrated in a single rising dose Phase 1 trial in 39 subjects with moderate to severe 
plaque PsO where 87% of subjects achieved at least 75% reduction in Psoriasis Area and 
Severity Index (PASI 75) with no safety concerns.37
In a Phase 2 dose-ranging trial of risankizumab vs. ustekinumab, the primary endpoint of 
PASI 90 response at Week 12 was achieved by 32.6% (14/43), 73.2% (30/41), and 81.0% 
(34/42) of risankizumab subjects in the 18 (single dose at Week 0), 90, and 180 mg (dosed 
at Weeks 0, 4 and 16) groups, respectively, and 40.0% (16/40) of ustekinumab subjects 
(dosed at Weeks 0, 4 and 16, weight based).  A two-sided Cochran-Mantel-Haenszel test 
of PASI 90 response at Week 12 between the 18, 90, and 180 mg groups of risankizumab, 
and ustekinumab, gave p-values of 0.4337, 0.0013, and < 0.0001, respectively.38  In 
addition, in this PsO trial, Pain Visual Analog Scale (pain-VAS [0 – 100 mm]) data over 
time was obtained from 46 subjects who had concurrently diagnosed PsA by a 
rheumatologist or suspected PsA.  The criterion of > 50% decrease in pain-VAS (defined 
post hoc, as one of the potential domains contributing to ACR 50 response) at Week 24 
was achieved in 16.7% (1/6), 81.8% (9/11), and 90.9% (10/11) of subjects on 
risankizumab18, 90, and 180 mg dose groups, respectively, compared with 57.1% (8/14) 
for ustekinumab.  In the risankizumab 90 and 180 mg dose arms the reductions in pain-
VAS score were observed as early as 4 weeks, and were highest at 24 weeks (Figure 1), 
supporting the therapeutic rationale of risankizumab in PsA.  Risankizumab was well 
tolerated in this Phase 2 study. 

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Figure 1.
Reduction in Pain – Rates of Subjects with > 50% Reduction in 
Pain-VAS Score from Baseline at Weeks 4, 12, and 24
BI655066 = risankizumab
After a single intravenous (i.v.) administration, risankizumab geometric mean AUC0-inf
ranged from 2.93 – 1650 day•μg/mL and Cmax from 0.311 – 110 μg/mL, with exposure 
increasing in a dose-proportional manner.  Group mean clearance and terminal phase 
volume of distribution were 0.33 L/day and 10.8 L, respectively.  PK parameter 
variability, expressed as gCV (%) was < 50%.  After a single subcutaneous administration 
of risankizumab, maximal exposures were reached between 5 – 13 days and subcutaneous 
bioavailability was 73% (expressed as the ratio of geometric mean dose normalized 
AUC0-inf after subcutaneous and i.v. administration).
For a more detailed description of the drug profile refer to the current Investigator's 
Brochure.36

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3.3
Differences Statement
Study M16-244 is a 52 week multicenter, single-arm, open-label extension (OLE), 
consisting of 36 weeks of study drug administration and 20 weeks follow-up, to 
Study 1311.5.  This is the first study to explore safety and efficacy of risankizumab in 
subjects diagnosed with PsA over this extended duration.  
3.4
Benefits and Risks
Participation in this study may generate data to support future use of risankizumab in 
larger groups of PsA patients.  Risankizumab has been studied in 46 PsO Phase 2 
Study 1311.2 subjects who had a diagnosis by a rheumatologist, or were suspected by an 
investigator, of also having PsA.  The rates of subjects with a > 50% reduction in pain-
VAS at Week 24 (from baseline) in the 90 mg and 180 mg of risankizumab arms were 
comparable with the ustekinumab arm and numerically better than in the risankizumab 
18 mg single dose arm.  In addition, 70 – 80% of subjects with moderate to severe PsO 
receiving 90 mg and 180 mg of risankizumab achieved PASI 90 in their skin disease.
Individual subjects, completing all doses of study drug and the Week 24 visit of 
Study 1311.5, whose response may benefit or be maintained as a result of increased or 
exposure of risankizumab will be offered the opportunity to enroll in the OLE.
Subjects who have not achieved a protocol defined response (defined as an improvement 
in tender and swollen joint count of ≥ 20% compared with the baseline in Study 1311.5) at 
Week 4 in the OLE trial will be offered an additional dose of risankizumab (150 mg 
subcutaneous), provided the investigator believes this may be beneficial to the subject.  If 
subjects have not attained a protocol defined response at 2 consecutive visits at Week 12 
visit, or thereafter, they will be discontinued from the OLE study.  Other criteria leading 
to discontinuation of individual subjects in this trial are described in Section 5.4.1.
As of March 2016, 546 adult subjects have received at least 1 dose of risankizumab in all 
completed and ongoing studies.  Unblinded safety data (at least up to completion of 

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randomized treatment period) are available on 465 subjects with PsO, Crohn's disease 
(CD) or ankylosing spondylitis, 358 of whom received risankizumab.
In the Phase 2 psoriasis trial (Study 1311.2), 126 subjects received risankizumab and the 
most commonly occurring AEs were nasopharyngitis (32%), headache (9%), back pain 
(6%), and arthralgia (5%).  In the Phase 2 CD trial (Study 1311.6), 82 subjects received 
risankizumab within the 12 weeks of the randomized treatment period and most frequent 
AEs were arthralgia (15%), nausea (13%), headache (12%), abdominal pain (11%), 
vomiting (6%), asthenia (6%), diarrhea (5%), pyrexia (5%), back pain (5%), dizziness 
(5%), and insomnia (5%).  In the Phase 2 ankylosing spondylitis trial (Study 1311.8), 
119 subjects received risankizumab during the placebo-controlled period of 12 weeks and 
the most commonly reported adverse events were nasopharyngitis (12%), headache 
(10%), fatigue (6%), diarrhea (5%), back pain (5%), and influenza (4%).  There was no 
relationship between treatment groups or doses and the overall frequency of AEs or the 
occurrence of AEs in specific organ classes, or any individual AE based on available 
unblinded safety data.
As with any biologic therapy, hypersensitivity reactions may be possible.  Local reactions 
following subcutaneous administration of risankizumab were uncommon, and limited to 
redness, swelling or induration at the injection site.  As with any immune modulating 
agent, risankizumab may impair immune function resulting in a risk of infection.  This 
will be monitored by collection of any AEs during the treatment and observation periods.  
There is not enough information at this time to rule out a risk of cancer with 
risankizumab, but this risk is considered small with this type of compound as experience 
with the anti-IL-12/23 mAb ustekinumab has not suggested significant risk for 
cancer/serious infection.  Subjects will be monitored for signs and symptoms of 
malignancy at each visit.
A cardiovascular, cerebrovascular, and thrombosis (CCVT) adjudication committee has 
been established for comprehensive assessment of this risk.  All possible major adverse 
cardiac event (MACE) and thrombotic events will be adjudicated and overall safety across 

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all indications will continue to be assessed by a risankizumab independent data 
monitoring committee.
For periodic updates on rare SAEs and the overall drug safety profile please refer to the 
current Investigator's Brochure.36
Anti-drug antibody (ADA) response was measured in the 24-week trial period in single 
ascending dose Study 1311.1 with SC and IV administration.  None of the subjects in the 
SC dose group tested positive.  From the IV dose group, 6 out of 18 subjects were ADA 
positive.  Four out of these 6 subjects had positive ADA response in their pre-dose 
samples and only 2 subjects had treatment emergent ADAs-not associated with any ADA-
specific AEs.  A neutralizing antibody assay was developed and implemented for 
subsequent trials.  In the Phase 2 psoriasis trial (Study 1311.2), treatment-emergent ADAs 
were detected in 13.7% of subjects receiving risankizumab (17 of 124 patients evaluated).  
In most subjects these were transient and/or low titer (< 32).  Neutralizing ADAs were 
observed in 3 subjects in the multiple dose risankizumab groups.
4.0
Study Objective
4.1
Primary Objective
The primary objective of Study M16-244 is to assess the safety and tolerability of 
risankizumab in PsA subjects who have completed all doses of study drug and the 
Week 24 visit in Study 1311.5.
4.2
Secondary Objectives
Secondary objectives include the assessment of efficacy of risankizumab and the impact 
of risankizumab on the inhibition of structural progression in PsA subjects who completed 
all doses of study drug and the Week 24 visit in Study 1311.5.

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5.0
Investigational Plan
5.1
Overall Study Design and Plan:  Description
This is a 52-week multicenter, single-arm, OLE study to assess safety, tolerability and 
efficacy of risankizumab in PsA subjects who have completed all doses of study drug and 
the Week 24 visit of Study 1311.5 (Phase 2 randomized clinical trial in PsA subjects, 
sponsored by Boehringer Ingelheim).
Subjects who complete all doses of study drug and the Week 24 visit in Study 1311.5, 
meet all inclusion criteria (Section 5.2.1) and none of the exclusion criteria (Section 5.2.2) 
have the option to sign the informed consent form and enter the OLE study, receiving 
risankizumab 150 mg administered every 12 weeks with an additional dose of 
rizankizumab made available at the Week 4 visit for those subjects that have not achieved 
a protocol defined response (defined as an improvement in tender and swollen joint count 
of ≥ 20% compared with the baseline in Study 1311.5), provided the investigator believes 
this may be beneficial to the subject. 
If the Study M16-244 Week 0 visit occurs on the same day or in the 4 days following the 
Study 1311.5 Week 24 visit only selected activities are required as some activities are 
common to both studies and are not required twice.  See Study Activity Table in 
Appendix C.  If the OLE Week 0 visit occurs > 4 days and ≤ 8 weeks after the 
Study 1311.5 Week 24 visit, all procedures specified in Appendix C at Week 0 visit are 
required.
Subjects that enroll in the OLE study are no longer enrolled in Study 1311.5 and will not 
complete the Week 28 or Week 32 visits in Study 1311.5.  
Subjects who are not enrolled in Study M16-244 within 8 weeks of the Study 1311.5 
Week 24 visit are not eligible to participate in Study M16-244.

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The study is anticipated to enroll up to 180 subjects.  Study visits will occur at 
Week 0/Enrollment, Weeks 4, 12, 24, 36, 48 and 52.  A ± 4 day window is permitted 
around scheduled study visits after enrollment.  
36-Week Treatment Period
Administration of study drug will occur at Week 0, 12, 24 and 36, with an additional dose 
of rizankizumab made available at the Week 4 visit for those subjects that have not 
achieved a protocol defined response (defined as an improvement in tender and swollen 
joint count of ≥ 20% compared with the baseline in Study 1311.5), provided the 
investigator believes this may be beneficial to the subject.  Subjects who have not attained 
a protocol defined response at 2 consecutive visits at Week 12 visit or thereafter, will be 
discontinued from the OLE study.  Other criteria leading to discontinuation of individual 
subjects in this trial are described in Section 5.4.1.
A ± 4-day window is permitted around scheduled study visits after enrollment.  If any 
visit has to be rescheduled, subsequent visits should follow the original visit date 
schedule.
Follow-Up Period
Subjects will have follow-up visits at Week 48 and 52 and a Follow-up Phone call 
20 weeks after the last dose of study drug.  All Follow-up Visit procedures are noted in 
Appendix C.  Subjects who discontinue study drug treatment early will need to attend an 
early End of Treatment (EOT) visit ideally within 2 weeks after the decision and 
preferably prior to the administration of any new therapies.  An End of Study (EOS) visit 
16 weeks after the last dose of study drug and a Follow-up Phone Call 20 weeks after the 
last dose of study drug is required to determine the status of any ongoing AEs/SAEs or the 
occurrence of any new AEs/SAEs (see Appendix C and Section 5.4.1).
A schematic of the study design is shown below in Figure 2.

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Figure 2.
Study M16-244 Study Design
5.2
Selection of Study Population
5.2.1
Inclusion Criteria
1.
Subjects who have completed all doses of study drug and Week 24 visit of 
Study 1311.5.
2.
Women of childbearing potential must agree to use at least one of the following 
methods of contraception throughout the study including 20 weeks after the last 
study drug dose is given.
●
combined (estrogen and progestogen containing) hormonal birth control (oral, 
intravaginal, transdermal) associated with inhibition of ovulation initiated at 
least 1 month prior to study participation.
●
progestogen-only hormonal birth control (oral, injectable, implantable) 
associated with inhibition of ovulation initiated at least 1 month prior to study 
participation.
●
bilateral tubal occlusion/ligation
●
intrauterine device (IUD) 
●
intrauterine hormone-releasing system (IUS).
●
Vasectomized sexual partner(s) (the vasectomized partner(s) should have 
received medical assessment of the surgical success and is the sole sexual 
partner of the trial participant).

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●
True abstinence:  Refraining from heterosexual intercourse when this is in line 
with the preferred and usual lifestyle of the subject (periodic abstinence 
[e.g., calendar, ovulation, symptothermal, post-ovulation methods] and 
withdrawal are not acceptable).
Women of childbearing potential are defined as having experienced menarche and 
are: 
●
not postmenopausal (12 months with no menses without an alternative medical 
cause) and are
●
not permanently sterilized (e.g., hysterectomy, bilateral oophorectomy or 
bilateral salpingectomy).  
3.
Women of childbearing potential must have a negative urine pregnancy test at 
Baseline (Week 0/V1).
4.
Subjects must voluntarily sign and date an informed consent, approved by an 
Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to 
the initiation of any study specific procedures.
5.
Subject is judged to be in good health as determined by the Investigator.
See Appendix D for inclusion criterion specific to France.
Rationale for the Inclusion Criteria:
1, 5
To select the adequate subject population
2, 3
The impact of risankizumab on pregnancy and reproduction is unknown
4
In accordance with harmonized Good Clinical Practice (GCP)
5.2.2
Exclusion Criteria
A subject will not be eligible for study participation if he/she meets any of the following 
criteria:

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1.
Female subject who is pregnant, breastfeeding or is considering becoming pregnant 
during study participation, including 20 weeks after the last dose of study drug is 
given.
2.
Premature discontinuation of study drug in Study 1311.5 for any reason.
3.
Use of a biologic treatment other than risankizumab since first dose of study drug 
in Study 1311.5.
4.
Time elapsed is > 8 weeks since the Week 24 visit in Study 1311.5.
5.
Active systemic infections during the last 2 weeks (exception:  common cold) prior 
to randomization, as assessed by the investigator.
6.
Anticipated requirement during the study or receipt of any live or attenuated 
vaccine since first dose administered in Study 1311.5.
7.
Participation in another investigational study since first dose of study drug in 
Study 1311.5.
8.
Current diagnosis of a major chronic inflammatory or connective tissue disease 
other than PsA (e.g., rheumatoid arthritis, systemic lupus erythematosus, 
ankylosing spondylitis, Lyme disease, gout) and fibromyalgia as assessed by the 
Investigator.  
9.
Use of any restricted medication as specified in this protocol or any drug 
considered likely to interfere with the safe conduct of the study, as assessed by the 
investigator, since first dose of study drug in Study 1311.5.
10.
History of allergy/hypersensitivity to a systemically administered biologic agent or 
its excipients.
11.
Chronic or relevant acute infections including HIV (human immunodeficiency 
virus), viral hepatitis and (or) active tuberculosis.
12.
Any documented active or suspected malignancy or history of malignancy since 
first dose of study drug in Study 1311.5, except appropriately treated basal or 
squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.

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13.
Major surgery (including weight loss surgery), performed since first dose of study 
drug in Study 1311.5 or planned while study is ongoing as assessed by the 
investigator.
14.
Evidence of a current or previous disease, medical condition (including chronic 
alcohol or drug abuse) other than PsA and PsO, surgical procedure (i.e., organ 
transplant), medical examination finding (including vital signs and 
electrocardiogram (ECG)), or laboratory value in Study 1311.5 outside the 
reference range that in the opinion of the investigator is clinically significant and 
would make the study participant unreliable to adhere to this protocol or to 
complete this trial, compromise the safety of the subject, compromise the quality of 
the data or for any reason cause the Principal Investigator (PI) to consider the 
subject an unsuitable candidate.
See Appendix D for inclusion criterion specific to France.
Rationale for Exclusion Criteria:
1
The impact of risankizumab on pregnancy and reproduction is 
unknown
2, 4, 8, 14
To select the adequate subject population
3, 5, 6, 7, 9 – 13
To ensure the safety of the subjects throughout the study
5.2.3
Prior and Concomitant Therapy
Any medication or vaccine (including over-the-counter or prescription medicines, 
vitamins and/or herbal supplements) that the subject is receiving at the time of enrollment, 
or receives during the study, must be recorded along with the reason for use, date(s) of 
administration including start and end dates, and dosage information including dose, route 
and frequency on the appropriate electronic case report form (eCRF).
The AbbVie Emergency Medical Contact should be contacted if there are any questions 
regarding concomitant or prior therapy(ies).

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5.2.3.1
Prior Therapy
Use of a biologic treatment is prohibited other than risankizumab since initiation in 
Study 1311.5.
Intra-articular corticosteroids are not permitted within the 4 weeks preceding enrollment 
and throughout the duration of Study M16-244.
5.2.3.2
Concomitant Therapy
Any medication or vaccines (including over-the-counter or prescription medicines, 
vitamins and/or herbal supplements) that the subject is receiving since Week 24 of 
Study 1311.5 and during the study, must be recorded along with the reason for use, date(s) 
of administration including start and end dates, and dosage information including dose, 
route and frequency on the appropriate eCRF.  The following therapies are allowed for 
concomitant use:
Methotrexate
Any subjects taking MTX (up to 25 mg/week) must be on a stable dose and stable route of 
administration for at least 4 weeks before enrollment and ideally maintain this dose 
throughout the study.  Reduction in the dose of MTX will be allowed if the subject can no 
longer tolerate their dose of MTX.
Folic Acid
Subjects on MTX must be taking folic acid supplementation according to local standard of 
care before enrollment and during the trial to minimize the likelihood of MTX associated 
toxicity.
Corticosteroids
Treatment with systemic corticosteroids is permitted up to a maximum daily dosage 
equivalent to prednisone ≤ 10 mg and if the dose was stable within the 2 weeks preceding 
enrolment.  The subject should remain on a stable dose throughout the study.

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Topical steroids of US class 6 (mild, such as desonide) or US class 7 (least potent, such as 
hydrocortisone) (see list in Appendix T) will be permitted for use limited to the face, 
axilla, and/or genitalia.  These topical medications should not be used within 
approximately 24 hours prior to a visit.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or Paracetamol/Acetaminophen 
PRN
Stable doses of non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase (COX) 
2 inhibitors, or Paracetamol/Acetaminophens are allowed throughout the study.  Subjects 
taking NSAIDs should be advised not to take NSAIDs at least 24 hours prior to study 
visit.  Substitution with another NSAID is permitted over the study duration. 
Paper diaries will be provided to subjects to record NSAID, COX-2 inhibitors or 
Paracetamol/Acetaminophen use throughout the Study M16-244.
Vitamin D
If the subject is taking vitamin D supplements, the subject should continue on stable doses 
throughout the duration of the trial.
Topical therapy
During the course of the study, subjects may continue treatment with medicated shampoos 
that do not contain corticosteroids, or bland (without beta or alpha hydroxy acids) 
emollients.  Application of these topical therapies for psoriasis, however, should not occur 
within 24 hours of a study visit.
5.2.3.3
Prohibited Therapy
Use of the following therapies is prohibited from administration of the first dose of study 
drug in Study 1311.5 throughout the duration of Study M16-244, including any gap 
between these two studies:
●
Investigational products not otherwise described below

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●
anti-IL-12/23, and anti-IL-17 agents, including ustekinumab and secukinumab
●
Cell-depleting therapies including but not limited to anti-CD20 
(e.g., rituximab), investigational agents (e.g., CAMPATH, anti-CD4, anti-
CD5, anti-CD3, anti-CD19)
●
TNF inhibitors
●
JAK inhibitor, Apremilast and leflunomide
●
Intra-articular injections (including steroids)
●
Intramuscular or intravenous corticosteroid treatment
●
Topical PsO treatments such as retinoids, Vitamin A analogs,  anthralin and 
steroids except as permitted in Section 5.2.3.2:  Concomitant Therapy 
●
Oral or injectable PsO medications (not biologicals) including retinoids and 
fumarates, or any other drugs known to possibly benefit PsO
●
Photochemotherapy (e.g., PUVA)
●
Any drug known to interfere with or to aggravate PsO including but not 
limited to lithium and interferons
●
Phototherapy (e.g., UVA, UVB)
●
Low and high potency opioid analgesics (e.g., methadone, hydromorphone, 
morphine)
●
Live or attenuated vaccines
5.2.4
Contraception Recommendations and Pregnancy
Female subjects of childbearing potential must be ready and able to use highly effective 
methods of birth control per International Conference on Harmonization (ICH) M3 (R2) 
that result in a low failure rate of less than 1% per year when used consistently and 
correctly.  Or subjects must have only vasectomized sexual partner(s) or be abstinent.  
The method chosen must be practiced throughout the study including 20 weeks after the 
last dose of study drug is given.

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Women of childbearing potential are defined as having experienced menarche and are:
●
not postmenopausal (12 months with no menses without an alternative medical 
cause)
●
not permanently sterilized (e.g., hysterectomy, bilateral oophorectomy or 
bilateral salpingectomy).
The following is a list of accepted contraception methods. 
●
combined (estrogen and progestogen containing) hormonal (oral, intravaginal, 
transdermal) birth control associated with inhibition of ovulation initiated at 
least 1 month prior to study participation
●
progestogen-only hormonal birth control (oral, injectable, implantable)  
associated with inhibition of ovulation  initiated at least 1 month prior to study 
participation
●
intrauterine device (IUD) 
●
intrauterine hormone-releasing system (IUS).  
●
Vasectomized sexual partner(s) (the vasectomized partner should have 
received medical assessment of the surgical success and is the sole sexual 
partner of the trial participant). 
●
True abstinence:  Refraining from heterosexual intercourse when this is in line 
with the preferred and usual lifestyle of the subject (periodic abstinence 
[e.g., calendar, ovulation, symptothermal, post-ovulation methods] and 
withdrawal are not acceptable). 
In addition, both female subjects of childbearing potential and male subjects with female 
partners of childbearing potential, taking MTX as background medication, must follow 
the national regulatory guidelines regarding contraception while taking these medications.
See Pregnancy Testing paragraph in Section 5.3.1.1 for pregnancy testing instructions.
See Appendix D for contraception instructions specific to France.

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5.3
Efficacy and Safety Assessments/Variables
5.3.1
Efficacy and Safety Measurements Assessed 
Study procedures described are listed in the following section of this protocol and are 
summarized in tabular format in Appendix C.
5.3.1.1
Study Procedures
Study procedures will be performed at the study visits as specified in Appendix C.  Study 
visits are scheduled at Week 0/Enrollment, Week 4, 12, 24, 36, 48 and 52.  Study 
procedures are discussed in detail in this section, with the exception of drug concentration 
measurements and antibody measurements (discussed in Section 5.3.2), study drug 
administration (discussed in Section 5.5.1), and the collection of adverse event (AE) 
information (discussed in Section 6.1.5).  All study data will be recorded in source 
documents and on the appropriate eCRFs.
Informed Consent
The subject will sign and date a study specific, Independent Ethics Committee 
(IEC)/Institutional Review Board (IRB) approved, informed consent form before any 
study specific procedures are performed in order to participate in this study.  Details 
regarding how informed consent will be obtained and documented are provided in 
Section 9.3.
Inclusion/Exclusion Criteria
Subjects will be evaluated to ensure they meet all inclusion criteria and have none of the 
exclusion criteria at the Week 0 visit.
Medical and Surgical History
Transcribe medical history from Study 1311.5 source documents and record any updates 
to represent the status of the Medical and Surgical History at the Week 0 visit.

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Demographics
The subject's demographic data, including date of birth, gender, race, and ethnicity will be 
collected.
Physical Examination
A complete or targeted physical examination will be performed at the designated study 
visits as specified in Appendix C.  A complete physical examination will include vital 
sign assessment and general appearance as well as evaluation of all organ systems.  
Targeted physical examination will include vital sign assessment and evaluation of organ 
systems associated with AE(s) symptoms or laboratory abnormalities.  Clinically relevant 
abnormal findings will be reported as baseline conditions or AEs.
All physical examination findings whether related to an AE or part of a subject's medical 
history will be recorded on the appropriate eCRF page.  For subjects rolling over from 
Study 1311.5 to the OLE, adverse events ending prior to completion of Study M16-244 
ICF will be recorded in preceding Study 1311.5. Abnormalities assessed by the 
Investigator after the subject has completed the informed consent process of 
Study M16-244 will be recorded in the eCRFs of Study M16-244.
Vital Signs
Vital signs evaluations will be performed at visits as shown in Appendix C.  
This includes temperature, pulse rate, systolic/diastolic blood pressure and respiratory 
rate.  Respiratory rate, pulse rate, and blood pressure will be measured after subjects have 
been sitting comfortably for at least 5 minutes.  Measurement of vital signs should 
precede blood sampling to avoid the impact of blood sampling on the vital measurements.
12-Lead Electrocardiogram (ECG)
The 12-lead ECGs will be performed as scheduled in Appendix C.

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ECGs will be recorded after the subjects have rested for at least 5 minutes in a supine 
position and will always precede blood sampling.  Six limb leads, as specified by 
Einthoven (I, II and III) and Goldberger (aVR, aVL, aVF), and six pre-cordial leads (V1 –
V6), according to Wilson, will be used.
ECGs may be repeated for quality reasons and the repeat used for analysis.  Additional 
ECGs may be collected for safety reasons at the Investigator's discretion.  Clinically 
relevant, abnormal findings will be reported as AEs.
The electronic version of the ECG is regarded as source data.  Dated and signed printouts 
will be stored in the subject's medical file. 
Pregnancy Testing
Women of non-childbearing potential (either postmenopausal or permanently surgically 
sterile as defined in Section 5.2.4) at Baseline in Study M16-244 do not require pregnancy 
testing.
For women of childbearing potential, as defined in Section 5.2.4 a urine pregnancy test 
will be done locally prior to enrollment at Day 1 (Week 0) and prior to dosing (where 
applicable) at each subsequent visit.  The urine pregnancy test must be negative for the 
dosing to occur.  If a urine pregnancy test is positive or a subject reports being pregnant 
during the study, the subject must stop dosing, and have blood drawn for a serum 
pregnancy test that will be analyzed at the central laboratory.  If the serum pregnancy test 
is positive, dosing must be stopped and the subject must follow the discontinuation 
procedure described in Section 5.4.1.
At each visit, the study staff should review the pregnancy avoidance recommendations 
with each subject of childbearing potential and document this discussion in the subject's 
source records.

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X-Ray Assessments
The modified Total Sharp Score (mTSS) method, including distal interphalangeal joints, 
will be used to evaluate radiographic evidence of damage.1 X-rays of hands, wrists and 
feet will be performed at two time points (Weeks 24 and 48, detailed in Appendix C).  
Images will be read centrally for each subject in a random order and without knowledge 
of time point, or subject identity, or treatment assignment in Study 1311.5.  Subjects who 
prematurely discontinue from study drug will not be required to collect x-rays at each 
designated time point, unless they received a dose within the 16 weeks prior to the 
scheduled time point.
See Appendix D for instructions specific to Germany.
Clinical Laboratory Tests
Subject will be instructed in advance to attend study visits in a fasted state (8 hours no 
food and only water).  If a patient comes in non-fasted where a fasting condition is 
required, the visit should be performed, the non-fasted condition documented on the 
laboratory requisition, and the patient reminded about the expected conditions.
Blood samples will be obtained for the laboratory tests listed in Table 1 at the specified 
time points noted in Appendix C depending on the subject's status in the study.  Blood 
draws should be performed after all clinical assessments and patient reported outcomes, 
ECGs, and vital sign determinations are obtained before study drug administration during 
a visit.
Urine samples will be obtained for urinalysis testing at the specified time points as listed 
in Table 1 and at the time points noted in Appendix C.  The central laboratory will be 
responsible for performing a macroscopic urinalysis (urine dipstick) on the collected urine 
specimens.  Specified abnormal macroscopic urinalyses will be followed up with a 
microscopic analysis at the central laboratory.

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A certified central laboratory will be utilized to process and provide results for the clinical 
laboratory tests.  All abnormal laboratory tests that are considered clinically significant by 
the investigator will be followed to a satisfactory resolution.  Laboratory abnormalities are 
considered to be adverse events only if they result in discontinuation from the study, 
necessitate therapeutic medical intervention, and/or if the Investigator considers them to 
be an adverse event.
Instructions regarding the collection, processing and shipping of these samples will be
provided by the central laboratory chosen for this study.

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Table 1.
Clinical Laboratory Tests
Category
Test Name
Hematology
Hematocrit (Hct)
Hemoglobin (Hb)
Red Blood Cell Count/Erythrocytes
Reticulocyte Count
White Blood Cells/Leukocytes
Platelet Count/Thrombocytes
Diff. Automatic
Neutrophils (relative count)
Eosinophils (relative count)
Basophils (relative count)
Monocytes (relative count)
Lymphocytes (relative count)
Diff. Manual (if Diff Automatic is abnormal)
Neutrophils, bands (Stabs)
Neutrophils, polymorphonuclear (PMN)
Eosinophils
Basophils
Monocytes
Lymphocytes
Coagulation
Partial Thromboplastin Time (aPTT)
Prothrombin time (INR)
Fibrinogen
Enzymes
AST (GOT)
ALT (GPT)
Alkaline Phosphatase (AP)
Creatine Kinase (CK)
CK-MB, only if CK is elevated
Gamma-Glutamyl Transferase (GGT/γ-GT)
Lactic Dehydrogenase (LDH)
Amylase
Lipase
Electrolytes
Calcium
Sodium
Potassium
Chloride
Bicarbonate

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Table 1.
Clinical Laboratory Tests (Continued)
Category
Test Name
Substrates
Glucose
BUN (blood urea nitrogen)
Uric acid
Creatinine
eGFR 
Bilirubin Total
Bilirubin Direct (if total is elevated)
Bilirubin Indirect (if total is elevated)
Troponin (Reflex, in case of elevated CK) 
Protein, Total
Albumin
C-Reactive Protein (CRP) (high sensitivity)
Cholesterol, total
Triglycerides
LDL-Cholesterol
HDL-Cholesterol
Urine Pregnancy test (only for women of 
childbearing potential) tested locally
Human Chorionic Gonadotropin in urine
Serum Pregnancy test (only if urine pregnancy 
test is positive)
Human Serum Chorionic Gonadotropin 
Tuberculosis Screen
TB Skin Test (tested locally) or QuantiFERON®-TB 
Gold
Urinalysis (dipstick)
Urine Nitrite
Urine Protein
Urine Glucose
Urine Ketone
Urobilinogen
Urine Bilirubin
Urine RBC/Erythrocytes
Urine WBC/Leukocytes
Urine pH
Urine creatinine

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Table 1.
Clinical Laboratory Tests (Continued)
Category
Test name
Urine-Sediment (microscopic examination, only 
if urinalysis abnormal)
Urine Sediment Bacteria
Urine Cast in Sediment
Urine Squamous Epithelial Cells
Urine Sed. Crys., Unspecified
Urine Sediment RBC/Erythrocytes
Urine Sediment WBC/Leucocytes
Clinically relevant abnormal findings will be reported as baseline conditions or AE's.  A 
clinically relevant value may be either in- or outside the reference range.  Clinically 
relevant abnormal laboratory test results must be confirmed and should be repeated until 
normalization or stabilization or until an alternative explanation has been found.  
Abnormal laboratory values will be also graded for intensity by using RCTC Version 2.0 
criteria developed by OMERACT.11
See Appendix D for Japan specific requirements.
Tuberculosis Screening
All subjects will be tested for TB by either the QuantiFERON-TB Gold Test (or 
equivalent) or a TB Skin Test or equivalent, most commonly the Purified Protein 
Derivative (PPD) at the Week 24 visit.  If premature discontinuation occurs prior to 
Week 24 visit TB testing should occur at EOS visit as specified in Appendix C.
A TB Skin Test or equivalent should be utilized only when a QuantiFERON®-TB Gold 
Test is not possible for any reason (unless both tests are required per local guidelines).  
●
QuantiFERON®-TB Gold Test will be analyzed by the central laboratory 
(QuantiFERON test is preferred over TB Skin Test).
●
If the QuantiFERON®-TB Gold Test is NOT possible (or if both the 
QuantiFERON®-TB Gold Test and the PPD Skin Test are required per local 
guidelines) the PPD Skin Test will be performed according to standard clinical 
practice.  

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●
The PPD Skin Test should be read by a licensed healthcare professional 
between 48 and 72 hours after administration.  A subject who does not return 
within 72 hours will need to be rescheduled for another skin test.  
●
The reaction will be measured in millimeters (mm) of induration and 
induration ≥ 5 mm is considered a positive reaction.  The absence of induration 
will be recorded as "0 mm" not "negative."  
●
If PPD and/or the QuantiFERON®-TB Gold test (or IGRA equivalent) is 
positive, or if there is a repeat indeterminate QuantiFERON®-TB Gold test (or 
IGRA equivalent) upon retesting, subjects may continue in the study if further 
work up (according to local practice/guidelines) establishes conclusively that 
the subject has no evidence of active tuberculosis.  
●
If the subject is diagnosed with active tuberculosis, the subject should not 
receive any further study drug and follow the premature treatment 
discontinuation procedure (Early EOT visit) in Section 5.4.1.
●
If presence of latent tuberculosis is established, then tuberculosis treatment 
may be deferred until completion of the trial according to clinical judgment of 
investigator and local country guidelines and it is also necessary to report it as 
an adverse event in the source documents and eCRFs.
●
If subject is known to have a positive QuantiFERON®-TB Gold or PPD test in 
Study 1311.5 Screening period do not repeat in this study. 
●
Subjects who have had an ulcerating reaction to the TB Skin Test in the past 
should not be re-exposed and should not be tested by a PPD skin test.
In the case of a tuberculosis-related adverse event, a supplemental case report form that 
provides additional information is to be completed by the investigator or designee.
See Appendix D for TB testing instructions for Japan sites.
Other Safety Parameters
Local Tolerability
Local tolerability at the administration site of the previous subcutaneous injection will be 
assessed by the investigator according to "swelling," "induration," "heat," "redness," 

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"pain," or "other findings" at the specified visits as noted in Appendix C.  Any abnormal 
findings at the injection site during the current visit will be reported as AEs.
Assessments and Patient Reported Outcomes
Clinical and patient reported efficacy endpoints will be assessed over the course of the 
study at the time points defined in Appendix C.  Patient Reported Outcomes (PROs) 
should be completed by the patient on his/her own in a pre-specified order in a quiet 
area/room before any other visit assessments or treatments, and, if possible, before any 
interaction with the investigator or other members of the study team.  Details of the 
following clinical, efficacy and patient reported efficacy assessments are listed in the 
appendices.
●
Tender (68) and Swollen (66) Joint Count
●
ACR Response Components
●
Dactylitis (LDI)
●
Enthesitis (LEI and SPARCC)
●
MDA
●
DAS28-hsCRP
●
EULAR response criteria
●
PsARC response
●
PASI and sPGA for patients with ≥ 3% BSA of psoriatic plaques at baseline in 
Study 1311.5 and/or current visit
●
mNAPSI
●
mTSS
Patient Reported Outcomes
The order of completion should be as follows, applicable for each PRO as specified in 
Appendix C.
●
PtGA

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●
Patient's Assessment of PsA Pain Intensity (VAS)
●
HAQ-DI
●
BASDAI – For subjects that presented with inflammatory spondylitis at 
baseline to Study 1311.5 based on investigator judgment.
●
SF-36
●
FACIT-F
Study Drug Administration
Refer to Section 5.5.1. 
Monitoring for Hypersensitivity Reactions
Subjects should be closely monitored for signs and symptoms of hypersensitivity 
reactions for approximately 2 hours after the first dose administration (baseline visit) and 
1 hour after all other dose administrations at study visits.  Hypersensitivity reactions 
should be treated according to medical standards.  Pre-medications for further injections 
might be considered and will be agreed on between investigator and the AbbVie Medical 
Director.
In the event of a suspected hypersensitivity reaction or other systemic post-dose reaction, 
a (PK/ADA) blood and urine sample will be collected once within 24 hours of the 
reaction.
In the event of a suspected systemic hypersensitivity reaction, a supplemental form that 
provides additional information is be completed by the investigator or designee.
5.3.2
Drug Concentration Measurements
5.3.2.1
Collection of Samples for Analysis
Blood Samples for Risankizumab Assay
Blood samples for risankizumab assay will be collected at each study visit by 
venipuncture into appropriately labeled collection tubes.  Blood collection will occur after 

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patient reported outcomes, clinical assessments, ECG, vital signs, and before study drug 
administration.  The time of collection will be recorded to the nearest minute and at the 
visits specified in Appendix C.
Seven samples will be collected per subject for PK analysis during the treatment and 
follow-up periods with the potential for one more sample collected in the event of a 
hypersensitivity reaction.
Blood Samples for Risankizumab Anti-Drug Antibody (ADA) Assay:
Blood samples for risankizumab ADA assay will be collected at each study visit by 
venipuncture into appropriately labeled collection tubes.  Blood collection will occur after 
questionnaires, clinical assessments, ECG, vital signs, and before study drug 
administration.  The time of collection will be recorded to the nearest minute and at the 
visits specified in Appendix C.
Seven samples will be collected per subject for ADA analysis during the treatment and 
follow-up periods with the potential for one more sample collected in the event of a 
hypersensitivity reaction.
5.3.2.2
Handling/Processing of Samples
Details for the handling and processing of the samples will be provided outside this 
protocol in the laboratory manual.
5.3.2.3
Disposition of Samples
The frozen plasma samples for risankizumab concentration and risankizumab ADA assays 
will be packed and shipped from the study site to the Central Laboratory according to 
instructions in the central laboratory Lab Manual.  An inventory of the samples included 
will accompany the package.

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5.3.2.4
Measurement Methods
Plasma concentrations of risankizumab and relative titers of risankizumab ADA will be 
determined using validated methods under the supervision of the Bioanalysis department 
at AbbVie.  Any additional analytes may be analyzed using non-validated methods.  
Plasma samples collected for risankizumab and risankizumab ADA analysis may be used 
for future assay development or validation activities.  Risankizumab ADA samples upon 
request may be used for the analysis of neutralizing anti-drug antibodies.
5.3.3
Efficacy Variables
The baseline as defined in Study 1311.5 will be used to derive the efficacy endpoints in 
this study.
5.3.3.1
Primary Endpoint(s)
Not applicable.
5.3.3.2
Secondary Endpoint(s)
●
ACR 20 response at all measured time points
●
Change in mTSS at Week 24 and 48 as compared to baseline
5.3.3.3
Further Endpoint(s)
Further efficacy endpoints will include, but are not limited to, the following:
●
ACR 50 at all measured time points
●
ACR 70 at all measured time points
●
Change in Tender Joint Count at all measured time points as compared to 
baseline
●
Change in Swollen Joint Count at all measured time points as compared to 
baseline
●
Change in HAQ-DI at all measured time points as compared to baseline
●
Change in SF-36 at all measured time points as compared to baseline

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●
Change in Dactylitis count at all measured time points as compared to baseline 
●
Change in SPARCC Enthesitis Index at all measured time points as compared 
to baseline 
●
Change in mNAPSI at all measured time points as compared to baseline
●
Change in PhGA (VAS) at all measured time points as compared to baseline
●
Change in Patient's Assessment of PsA Pain Intensity (VAS) at all measured 
time points as compared to baseline
●
Change in PtGA assessments at all measured time points as compared to 
baseline
●
Change in High sensitivity C-Reactive Protein (hsCRP) at all measured time 
points as compared to baseline
●
Minimal disease activity (MDA) at all measured time points 
●
Change in DAS28-hsCRP at all measured time points as compared to baseline
●
PsO endpoints assessed at all measured time points in subjects with a ≥ 3% 
baseline PsO BSA:
○
PASI 75 and PASI 90 response
○
Change in sPGA clear and almost clear
●
EULAR (European League Against Rheumatism) response at all measured 
time points
●
Change in PsARC (Psoriatic Arthritis Response Criteria) at all measured time 
points as compared to baseline
●
Presence of dactylitis (yes/no) at all measured time points
●
Change in LDI at all measured time points as compared to baseline
●
Change in LEI at all measured time points as compared to baseline
●
Change in FACIT-F at all measured time points as compared to baseline
●
Change in BASDAI at all measured time points (in subjects with baseline 
inflammatory spondylitis, based on investigator judgment, in Study 1311.5) as 
compared to baseline

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5.3.4
Safety Variables
Safety will be assessed descriptively based on:
●
Adverse events*
●
Serious adverse events (SAEs)
●
Clinical laboratory values (hematology, clinical chemistry and urinalysis)
●
Physical examination
●
Vital signs
●
12-lead ECG
●
Local tolerability
*
Intensity of adverse events will be assessed by Rheumatology Common Toxicity
Criteria (RCTC) version 2.0 developed by OMERACT.11
5.3.5
Pharmacokinetic Variables
Risankizumab plasma concentrations will be determined.  PK and ADA data may be 
combined with data from other studies and analyzed using a mixed-effects modeling 
approach.  This analysis will estimate the population central value and the empirical 
Bayesian estimates of the individual values for risankizumab apparent clearance (CL/F) 
and volume of distribution (Vss/F).  Additional parameters may be estimated if useful in 
the interpretation of the data.
5.4
Removal of Subjects from Therapy or Assessment
5.4.1
Discontinuation of Individual Subjects
A subject may withdraw from the study at any time.  The Investigator may discontinue 
any subject's participation for any reason, including an adverse event, safety concerns or 
failure to comply with this protocol.

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Subjects will be withdrawn from the study drug and prematurely discontinued if any of 
the following occur:
●
A subject does not attain a protocol defined response (defined as an 
improvement in tender and swollen joint count of ≥ 20% compared with the 
baseline in Study 1311.5) at 2 consecutive visits at Week 12 visit, or thereafter.
●
A subject experiences a moderate/grade 2 or above (Rheumatology Common 
Toxicity Criteria v 2.0) non-serious AE of a systemic hypersensitivity reaction, 
for which there is no clear alternative explanation.
●
A subject experiences a moderate/grade 2 adverse event of vasculitis 
(Rheumatology Common Toxicity Criteria v 2.0) for which there is no clear 
alternative explanation. 
●
Subject experiences severe, grade 3 or greater, or life threatening injection site 
reaction (ISR) (as defined by the Rheumatology Common Toxicity Criteria 
v 2.0) which includes prolonged induration, superficial ulceration and includes 
thrombosis or major ulceration or necrosis requiring surgery.
●
A subject has a confirmed platelet count < 50,000 cells/mm3 (Rheumatology 
Common Toxicity Criteria v 2.0). 
●
Clinically significant confirmed abnormal laboratory results or adverse events, 
which rule out continuation of the study drug, as determined by the 
Investigator and the AbbVie study designated physician.
●
The Investigator believes it is in the best interest of the subject.
●
The subject requests withdrawal from the study, and is no longer willing to 
participate in study procedures or receive contact from the site.
●
Inclusion and exclusion criteria violation was noted after the subject started 
study drug, when continuation of the study drug would place the subject at risk 
as determined by the AbbVie study designated physician.
●
Introduction of prohibited medications or dosages when continuation of the 
study drug would place the subject at risk as determined by the AbbVie study 
designated physician.
●
The subject becomes pregnant while on study drug.

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●
Subject is significantly non-compliant with study procedures which would put 
the subject at risk for continued participation in the trial in consultation with 
the AbbVie study designated physician.
If, during the course of study drug administration, the subject prematurely discontinues 
study participation, the procedures outlined for the early EOT visit must be completed, 
ideally within 2 weeks of the decision and preferably prior to the initiation of another 
therapy.  However, these procedures should not interfere with the initiation of any new 
treatments or therapeutic modalities that the Investigator feels are necessary to treat the 
subject's condition.  For subjects that prematurely discontinue, study drug will not be 
given at the early EOT visit and subjects should attend their EOS Visit 16 weeks after last 
study drug dose and complete a Follow-up Phone Call 20 weeks after the last dose of 
study drug to determine the status of any ongoing AEs/SAEs or the occurrence of any new 
AEs/SAEs (see Appendix C).
Subjects who prematurely discontinue from study drug will not be required to collect x-
rays at a designated time point, unless they received a dose within the 16 weeks prior to 
the scheduled time point.
All attempts must be made to determine the primary reason for premature discontinuation.  
The information will be recorded on the appropriate eCRF page.
For subjects that are considered lost to follow-up, reasonable attempts must be made to 
obtain information on the final status of the subject.  At a minimum, two phone calls must 
be made and one certified letter must be sent and documented in the subject's source 
documentation.
Subjects who discontinue the study prematurely will not be replaced.
5.4.2
Discontinuation of Entire Study
AbbVie may terminate this study prematurely, either in its entirety or at any study site, for 
reasonable cause provided that written notice is submitted in advance of the intended 

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termination.  The investigator may also terminate the study at his/her site for reasonable 
cause, after providing written notice to AbbVie in advance of the intended termination.  
Advance notice is not required by either party if the study is stopped due to safety 
concerns.  If AbbVie terminates the study for safety reasons, AbbVie will immediately 
notify the investigator by telephone and subsequently provide written instructions for 
study termination.
5.5
Treatments
5.5.1
Treatments Administered
All subjects will receive subcutaneous injections of risankizumab by two 75 mg (150 mg 
total) pre-filled syringes starting at Week 0 and every 12 weeks thereafter over a 36 week 
period with a possibility of an additional dose at the Week 4 visit.  A subject will be 
eligible for the additional 150 mg dose at the Week 4 visit if they have not achieved a 
protocol response (defined as an improvement in tender and swollen joint count of ≥ 20% 
compared with the baseline in Study 1311.5) and the investigator believes this may be 
beneficial to the subject.
Risankizumab will be administered as a subcutaneous injection in the abdomen, thighs, 
gluteal regions, or upper arms (contra-lateral to that used for pharmacokinetic 
(PK)/pharmacodynamics (PD) samples).  The two injections done subsequently should be 
at least 2 cm apart and should not be close to a vein.  The injection sites should avoid sites 
of psoriasis involvement as well as sites where the skin is tender, bruised, erythematous, 
or indurated and should be alternated to other areas for subsequent doses.  Additional 
dosing instructions will be provided.
Subjects are to remain at the site to allow the site to monitor for signs and symptoms of 
hypersensitivity reactions for approximately 2 hours after the dose administered at 
Week 0 visit and 1 hour following all other doses of study drug (visits after Week 0).

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In addition, study personnel administrating the injections should be trained in diagnosing 
and treating acute allergic reactions, as well as there should be immediate access to 
medication and equipment to treat such reactions.
5.5.2
Identity of Investigational Product
Information about the risankizumab formulation to be used in this study is presented in 
Table 2.
Risankizumab supplies will be provided by Boehringer Ingelheim Pharma GmbH & Co 
KG, Biberach, Germany.
●
Risankizumab (ABBV-066) 75 mg/0.83 mL Solution for Injection Pre-filled 
Syringe
Risankizumab is presented in a 1 mL pre-filled syringe with 0.87 mL of solution for 
injection.  Dispensed volume is 0.83 mL.  The solution in the risankizumab syringes has a 
concentration of 90 mg/mL, to deliver 75 mg per syringe.  Two (2) syringes will be used 
to achieve the 150 mg dose.
Table 2.
Identity of Investigational Product
Study Drug
Dosage Form
Strength
Route of 
Administration
Manufacturer
Risankizumab 
(ABBV-066)
Solution for 
injection in pre-
filled syringe
75 mg/0.83 mL
Subcutaneous 
injection
Boehringer 
Ingelheim Pharma 
GmbH & Co. KG
5.5.2.1
Packaging and Labeling
Study drug packaged in 75 mg pre-filed syringes will be provided in open-label fashion 
and packaged in cartons containing one (1) syringe per carton.  Each kit will be labeled as 
required per local requirements.  The number of kits dispensed will be managed by the 
IRT (Interactive Response System).

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All labels must remain affixed to the study drug at all times, and should never be removed 
for any reason.
5.5.2.2
Storage and Disposition of Study Drug(s)
Risankizumab kits will be kept protected from light in their original packaging, in a 
refrigerator between 2°C to 8°C (36°F to 46°F), and within a secure limited access storage 
area, and in accordance with the recommended storage conditions on the label.  Study 
medication drug must not be frozen at any time.  A temperature log must be maintained 
for documentation.
The refrigerator temperature must be recorded each business day.  Malfunctions or any 
temperature excursion must be reported to the Sponsor immediately.  Study drug should 
be quarantined and not dispensed until AbbVie or the AbbVie Temperature Excursion 
Management System (ATEMS) deems the drug as acceptable.
All clinical supplies must be stored and locked in a secure place until they are dispensed 
for subject use or are returned to AbbVie.
Investigational products are for investigational use only and are to be used only within the 
context of this study.
5.5.3
Method of Assigning Subjects to Treatment Groups
This is an open-label study.  The treatment is the same for all subjects so there is no 
assignment of subjects to treatment groups.
Study drug will be administered at the study visits summarized in Appendix C.
5.5.4
Selection and Timing of Dose for Each Subject
An IRT will be used to allocate study drug to subjects.  At visits where study drug is to be 
administered, study sites will be required to complete the study drug resupply module in 
the IRT to receive assigned study drug/kit numbers.

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Study drug will be administered at the study site by authorized study personnel 
(e.g., study nurse).
Injections will be given in an open label fashion with each subject receiving 2 injections 
of risankizumab (75 mg) at each dosing visit.
Dose modifications or adjustments are not permitted.  In exceptional cases of missed or 
delayed visits, study drug of the following visit should not be administered within 14 days 
of the prior dose.  There should be at least 14 days between two consecutive study drug 
administrations.
5.5.5
Treatment Compliance
The investigator or his/her designated and qualified representatives will administer study 
drug only to subjects enrolled in the study in accordance with this protocol.  The study 
drug must not be used for reasons other than that described in this protocol.
5.5.6
Drug Accountability
The investigator and/or named subinvestigators must agree not to supply study drug to 
any persons not enrolled in the study.
The investigator or representative will verify that study drug supplies are received intact at 
the appropriate temperature (temperature recording devices [e.g., TempTales] are 
provided in the shipments), and in the correct amounts from the drug depot. 
This will be documented by signing and dating the Proof of Receipt (POR) or similar 
document included with each drug shipment, and via direct reporting in the IRT.  The 
original POR note or similar document will be kept in the site files as a record of what 
was received.
An accurate running inventory of study drug will be kept by the site, and will include the 
kit number, lot number, subject number, Proof of Receipt number(s), the number of pre-

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filled syringes dispensed, initials of person who dispensed/administered the drug, and the 
date study drug was administered for each subject.
All empty Investigational Product boxes and used pre-filled syringes will be inventoried 
by the site.  Each site will use their own sharps disposal container designated to store used 
pre-filled syringes from the Study M16-244.  Empty Investigational Product boxes and 
sharps containers should be retained by the site for accountability and compliance 
purposes.  Empty Boxes and sharps containers will be retained (unless prohibited by local 
law) until the CRA is on site to confirm the returned study drug.  CRAs and site staff will 
complete study drug accountability via study drug logs, source documents, subject dosing 
sheets, empty IP boxes and by visually inspecting the syringes in the sharps container 
whenever possible.  Used sharps containers should never be opened.
An overall accountability of the study drug will be performed and verified by AbbVie 
monitor throughout the study and at the site close-out visit.  After verification of drug 
accountability, used syringes must be destroyed at the site according to local regulations 
governing biohazardous waste.  Destruction of used study supplies must be documented.  
All unused supplies must be inventoried, accounted for and destroyed on site according to 
local procedures or regulation or returned to a destruction facility by the CRA.  A copy of 
the Drug Accountability Form, in accordance with instructions provided by the AbbVie 
monitor, will be included in the return shipments.
5.6
Discussion and Justification of Study Design
5.6.1
Discussion of Study Design and Choice of Control Groups
Subjects who have completed all doses of study drug and the Week 24 visit of 
Study 1311.5 and meet all the inclusion criteria and none of the exclusion criteria will be 
allowed to enroll in the Study M16-244 to receive risankizumab for up to 36 weeks.  The 
primary objective of Study M16-244 is to assess the safety and tolerability of 
risankizumab in subjects with PsA.  All subjects will receive risankizumab 150 mg 
subcutaneous every 12 weeks in an open-label fashion with the possibility of an additional 
dose at the Week 4 visit to subjects who have not achieved a protocol defined response 

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(defined as an improvement in tender and swollen joint count of ≥ 20% compared with the 
baseline in Study 1311.5) and the investigator believes that this additional dose may be 
beneficial to the subject.
5.6.2
Appropriateness of Measurements
All efficacy measurements in this study are standard and validated for psoriatic arthritis 
and/or psoriasis.  All clinical and laboratory procedures in this study are standard and 
generally accepted.
5.6.3
Suitability of Subject Population
This OLE study will enroll subjects who have completed all doses of study drug and 
Week 24 visit of Study 1311.5.  Only those subjects who have met all of the specified 
inclusion and none of the exclusion criteria will have an option to enter into the OLE 
study to receive risankizumab, as long as the subject is willing and the Investigator 
believes that receiving risankizumab is appropriate.  The study population selected in this 
study reflects the standard population for PsA trials with new intervention.
5.6.4
Selection of Doses in the Study
Risankizumab doses of 150 mg subcutaenous administered with different dosing 
frequencies (every 4 weeks to every 12 weeks) and 75 mg subcutaneous administered as a 
single dose are currently being evaluated in the Phase 2 study (Study 1311.5) in subjects 
with psoriatic arthritis.  In addition, risankizumab dose of 150 mg subcutaneous 
administered at Week 0, 4 and then every 12 weeks for up to 104 weeks is currently being 
evaluated in the Phase 3 studies in subjects with psoriasis.  The Phase 2 studies of 
risankizumab in subjects with psoriasis and CD have evaluated risankizumab doses up to 
180 mg subcutaneous administered at Week 0, 4 and then every 12 weeks (in subjects 
with psoriasis) and up to 600 mg administered intravenously every 4 weeks for up to 
26 weeks as induction treatment followed by 180 mg subcutaeous administered every 
8 weeks during maintenance period (in subjects with CD).  

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As of March 2016, 546 adult subjects have received at least 1 dose of risankizumab in all 
completed and ongoing studies.  Unblinded safety data (at least up to completion of 
randomized treatment period) are available on 465 subjects with PsO, CD and ankylosing 
spondylitis subjects, 358 of whom received risankizumab.
The doses of risankizumab evaluated in these studies have been found to be well tolerated.  
There was no relationship between risankizumab dose and the overall frequency of AEs, 
the occurrence of AEs in specific organ classes, or any individual AE (Risankizumab IB, 
version 7).
The risankizumab exposures at the dose of 150 mg every 12 weeks to be administered in 
this study will be covered by the doses administered or currently being administered in 
other Phase 2 and 3 studies in subjects with psoriasis, psoriatic arthritis and CD.  At 
Week 4 in this study, if a subject has not achieved a protocol defined response (defined as 
a clinical response is defined as an improvement in tender and swollen joint count of 
≥20% compared with the baseline in Study 1311.5), an additional dose of risankizumab 
can be administered, provided the investigator believes this may be beneficial to the 
subject.  In summary, this dose has been well tolerated in previous studies with 
demonstrated efficacy in PsO Phase 2 trials.  Some of the subjects treated for PsO also 
had PsA.  The majority of these PsA subjects experienced an improvement in pain-VAS 
using risankizumab dosed at 0, 4 and 16 weeks.  Given the safety and efficacy profile to 
date, this dose and schedule was chosen.
6.0
Complaints
A Complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the physical characteristics, identity, quality, purity, potency, durability, 
reliability, safety, effectiveness, or performance of a product/device after it is released for 
distribution.
The investigational product in this trial contains both: 
●
Biologic compound and

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●
Device component (pre-filled syringe).
Complaints associated with any component of this investigational product must be 
reported to the Sponsor (Section 6.2.2).  For adverse events, please refer to Section 6.1.  
For product complaints, please refer to Section 6.2.
6.1
Medical Complaints
The investigator will monitor each subject for clinical and laboratory evidence of adverse 
events on a routine basis throughout the study.  The investigator will assess and record 
any adverse event in detail including the date of onset, event diagnosis (if known) or 
sign/symptom, severity, time course (end date, ongoing, intermittent), relationship of the 
adverse event to study drug, and any action(s) taken.  For serious adverse events 
considered as having "no reasonable possibility" of being associated with study drug, the 
investigator will provide an Other cause of the event.  For adverse events to be considered 
intermittent, the events must be of similar nature and severity.  Adverse events, whether in 
response to a query, observed by site personnel, or reported spontaneously by the subject 
will be recorded.
All adverse events will be followed to a satisfactory conclusion.  Subjects who 
discontinue for an AE should have careful and regular follow-up in this interval to ensure 
full resolution of the AE.
6.1.1
Definitions
6.1.1.1
Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence in a patient or 
clinical investigation subject administered a pharmaceutical product and which does not 
necessarily have a causal relationship with this treatment.  An adverse event can therefore 
be any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of a medicinal (investigational) 
product, whether or not the event is considered causally related to the use of the product.

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Such an event can result from use of the drug as stipulated in protocol or labeling, as well 
as from accidental or intentional overdose, drug abuse, or drug withdrawal.  Any 
worsening of a pre-existing condition or illness is considered an adverse event.  
Worsening in severity of a reported adverse event should be reported as a new adverse 
event.  Laboratory abnormalities and changes in vital signs are considered to be adverse 
events only if they result in discontinuation from the study, necessitate therapeutic 
medical intervention, and/or if the investigator considers them to be adverse events.
An elective surgery/procedure scheduled to occur during a study will not be considered an 
adverse event if the surgery/procedure is being performed for a pre-existing condition and 
the surgery/procedure has been pre-planned prior to study entry.  However, if the pre-
existing condition deteriorates unexpectedly during the study (e.g., surgery performed 
earlier than planned), then the deterioration of the condition for which the elective 
surgery/procedure is being done will be considered an adverse event.
Prior to use, every attempt should be made to contact the AbbVie Study Designated 
Physician for direction on re-introduction of study drug therapy after prohibited 
medication administration.
6.1.1.2
Serious Adverse Events
If an adverse event meets any of the following criteria, it is to be reported to AbbVie as a 
serious adverse event (SAE) within 24 hours of the site being made aware of the serious 
adverse event.
Death of Subject
An event that results in the death of a subject.
Life-Threatening
An event that, in the opinion of the investigator, would 
have resulted in immediate fatality if medical 
intervention had not been taken.  This does not include an 
event that would have been fatal if it had occurred in a 
more severe form.

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Hospitalization or 
Prolongation of 
Hospitalization
An event that results in an admission to the hospital for 
any length of time or prolongs the subject's hospital stay.  
This does not include an emergency room visit or 
admission to an outpatient facility.
Congenital Anomaly
An anomaly detected at or after birth, or any anomaly 
that results in fetal loss.
Persistent or Significant 
Disability/Incapacity
An event that results in a condition that substantially 
interferes with the activities of daily living of a study 
subject.  Disability is not intended to include experiences 
of relatively minor medical significance such as 
headache, nausea, vomiting, diarrhea, influenza, and 
accidental trauma (e.g., sprained ankle).
Important Medical Event 
Requiring Medical or 
Surgical Intervention to 
Prevent Serious Outcome
An important medical event that may not be immediately 
life-threatening or result in death or hospitalization, but 
based on medical judgment may jeopardize the subject 
and may require medical or surgical intervention to 
prevent any of the outcomes listed above (i.e., death of 
subject, life-threatening, hospitalization, prolongation of 
hospitalization, congenital anomaly, or persistent or 
significant disability/incapacity).  Additionally, any 
elective or spontaneous abortion or stillbirth is considered 
an important medical event.  Examples of such events 
include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency 
or drug abuse.
For serious adverse events with the outcome of death, the date and cause of death will be 
recorded on the appropriate case report form.
6.1.1.3
Adverse Events of Special Interest (AESI)
The term AESI relates to any specific AE that has been identified at the compound level 
as being of particular concern for prospective safety monitoring and safety assessment 

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within this trial, e.g., the potential for AEs based on knowledge from other compounds in 
the same class.  Ongoing evaluation of adverse events may identify future AESI.
The following are considered as AESI:
Hepatic Injury
A hepatic injury is defined by the following alterations of hepatic laboratory parameters:
●
an elevation of AST and/or ALT > 3-fold ULN combined with an elevation of 
total bilirubin > 2-fold ULN measured in the same blood draw sample, and/or
●
marked peak aminotransferase (ALT, and/or AST) elevations ≥ 10-fold ULN.
These lab findings constitute a hepatic injury alert and the subjects showing these lab 
abnormalities need to be followed up as outlined in the hepatic injury CRF. 
In case of clinical symptoms of hepatic injury (icterus, unexplained encephalopathy, 
unexplained coagulopathy, right upper quadrant abdominal pain, etc.) without lab results 
(ALT, AST, total bilirubin) available, the investigator should make sure these parameters 
are analysed, if necessary with an unscheduled blood test.  Should the results meet the 
criteria of hepatic injury alert, investigators are advised to provide a hepatic workup as 
outline in the hepatic injury CRF.
Study drug should be discontinued if any of the following laboratory values listed below 
have been confirmed by repeat testing with a new sample:
●
ALT or AST > 3 × ULN and (Total bilirubin [TBL] > 2 × ULN or 
International Normalized Ratio [INR] > 1.5)
●
ALT or AST > 3 × ULN with the appearance of fatigue, nausea, vomiting, 
right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%)
●
ALT or AST > 8 × ULN
●
ALT or AST > 5 × ULN for more than 2 weeks

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In the case of a hepatic-related adverse event diagnosed clinically or by laboratory 
findings, a supplemental case report form that provides additional information will be 
completed by the investigator or designee.
6.1.2
Adverse Event Severity
Intensity of AEs
The intensity grading of AEs will be performed according to Rheumatology Common 
Toxicity Criteria (RCTC) Version 2.0 developed by OMERACT.11  Refer to the 
Investigator Site File (ISF) for intensity/severity classification.  Intensity options are:
Grade 1
mild
Grade 2
moderate
Grade 3
severe
Grade 4
life-threatening
6.1.3
Relationship to Study Drug
The investigator will use the following definitions to assess the relationship of the adverse 
event to the use of study drug:
Reasonable Possibility
An adverse event where there is evidence to suggest a 
causal relationship between the study drug and the 
adverse event.
No Reasonable Possibility
An adverse event where there is no evidence to suggest a 
causal relationship between the study drug and the 
adverse event.
For causality assessments, events assessed as having a reasonable possibility of being 
related to the study drug will be considered "associated."  Events assessed as having no 
reasonable possibility of being related to study drug will be considered "not associated."  
In addition, when the investigator has not reported a causality or deemed it not assessable, 
AbbVie will consider the event associated.

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If an investigator's opinion of no reasonable possibility of being related to study drug is 
given, an Other cause of event must be provided by the investigator for the serious 
adverse event.
6.1.4
Adverse Event Collection Period
All adverse events reported from the time of study drug administration until 20 weeks, 
following discontinuation of study drug administration have elapsed will be collected, 
whether solicited or spontaneously reported by the subject.  In addition, serious adverse 
events and protocol-related non-serious adverse events will be collected from the time the 
subject signed the study-specific informed consent.
Adverse event information will be collected as shown in Figure 3.
Figure 3.
Adverse Event Collection
6.1.5
Adverse Event Reporting
In the event of a serious adverse event, whether associated with study drug or not, the 
Investigator will notify Clinical Pharmacovigilance within 24 hours of the site being made 
aware of the serious adverse event by entering the serious adverse event data into the 
electronic data capture (EDC) system.  Serious adverse events that occur prior to the site 
having access to the RAVE® system, or if RAVE is not operable, should be documented 

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on the SAE Non-CRF forms and emailed (preferred route) or faxed to Clinical 
Pharmacovigilance within 24 hours of the site being made aware of the serious adverse 
event. 
Email: 
FAX to
For safety concerns, contact the Immunology Safety Team at:
Immunology Safety Team
1 North Waukegan Road
North Chicago, IL 60064
USA
Office:
Email:
For any subject safety concerns, please contact the physician listed below:
Primary Therapeutic Area Medical Director:

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In emergency situations involving study subjects when the Primary Therapeutic Area 
Medical Director (TA MD) is not available by phone, please contact the 24-hour AbbVie 
Medical Escalation Hotline where your call will be re-directed to a designated backup 
AbbVie TA MD: 
24-hour AbbVie Medical Escalation Phone Hotline:  
The sponsor will be responsible for Suspected Unexpected Serious Adverse Reactions 
(SUSAR) reporting for the Investigational Medicinal Product (IMP) in accordance with 
Directive 2001/20/EC.  The reference document used for SUSAR reporting in the EU 
countries will be the most current version of the Investigator's Brochure.  
In Japan, the principal investigator will provide documentation of all serious adverse 
events to the Director of the investigative site and the Sponsor.
6.1.6
Pregnancy
Pregnancy in a study subject must be reported to AbbVie within 1 working day of the site 
becoming aware of the pregnancy.  Subjects who become pregnant during the study must 
be discontinued (Section 5.4.1).
Information regarding a pregnancy occurrence in a study subject and the outcome of the 
pregnancy will be collected.
Pregnancy in a study subject is not considered an adverse event.  However, the medical 
outcome of an elective or spontaneous abortion, stillbirth or congenital anomaly is 
considered a serious adverse event and must be reported to AbbVie within 24 hours of the 
site becoming aware of the event.

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6.2
Product Complaint
6.2.1
Definition
A Product Complaint is any Complaint (see Section 6.0 for the definition) related to the 
biologic or drug component of the product or to the medical device component(s).
For a product this may include, but is not limited to, damaged/broken product or 
packaging, product appearance whose color/markings do not match the labeling, labeling 
discrepancies/inadequacies in the labeling/instructions (example:  printing illegible), 
missing components/product, device not working properly, or packaging issues.
For medical devices, a product complaint also includes all deaths of a patient using the 
device, any illness, injury, or adverse event in the proximity of the device, an adverse 
event that could be a result of using the device, any event needing medical or surgical 
intervention including hospitalization while using the device and use errors.
Any information available to help in the determination of causality by the device to the 
events outlined directly above should be captured.
6.2.2
Reporting
Product Complaints concerning the investigational product and/or device must be reported 
to the Sponsor within 24 hours of the study site's knowledge of the event via the Product 
Complaint form.  Product Complaints occurring during the study will be followed-up to a 
satisfactory conclusion.  All follow-up information is to be reported to the Sponsor (or an 
authorized representative) and documented in source as required by the Sponsor.  Product 
Complaints associated with adverse events will be reported in the study summary.  All 
other complaints will be monitored on an ongoing basis.
Product Complaints may require return of the product with the alleged complaint 
condition (syringe).  In instances where a return is requested, every effort should be made 
by the investigator to return the product within 30 days.  If returns cannot be 

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accommodated within 30 days, the site will need to provide justification and an estimated 
date of return.
The description of the complaint is important for AbbVie in order to enable AbbVie to 
investigate and determine if any corrective actions are required.
7.0
Protocol Deviations
AbbVie does not allow intentional/prospective deviations from this protocol unless when 
necessary to eliminate an immediate hazard to study subjects.  The principal investigator 
is responsible for complying with all protocol requirements, and applicable global and 
local laws regarding protocol deviations.  If a protocol deviation occurs (or is identified) 
after a subject has been enrolled, the principal investigator is responsible for notifying 
Independent Ethics Committee (IEC)/Institutional Review Board (IRB) regulatory 
authorities (as applicable), and the following AbbVie Clinical Monitor(s):
Primary Contact:
Alternate Contact:
Such contact must be made as soon as possible to permit a review by AbbVie to 
determine the impact of the deviation on the subject and/or the study.
See Appendix D for Japan specific requirements.

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8.0
Statistical Methods and Determination of Sample 
Size
8.1
Statistical and Analytical Plans
8.1.1
Datasets for Analysis
The analysis set consists of all subjects who enrolled into this OLE study and received at 
least one dose of open-label study drug.  This analysis set will be the primary analysis 
population for both efficacy and safety analysis.
8.1.2
Subject Accountability
The number of subjects who received at least 1 dose of study drug, the number of subjects 
who completed the study, and the number of subjects who prematurely discontinued will 
be summarized overall and by site.
8.1.3
Demographic and Baseline Characteristics
Demographic and baseline disease characteristics endpoints from Study 1311.5 will be 
summarized descriptively.  Summary statistics for continuous variables will include the 
number of observations, mean, standard deviation, median, Q1, Q3 and range for 
continuous variables; frequencies and percentages for the discrete variables.
8.1.4
Subject Disposition and Study Drug Exposure
8.1.4.1
Subject Disposition 
The number and percentage of subjects who are enrolled and received at least one dose of 
study drug, and the number of subjects who prematurely discontinued and the reason for 
premature discontinuation will be summarized.  Premature discontinuation of study drug 
will be summarized with frequencies and percentages overall and by reason for 
discontinuation for all subjects who received at least one dose of study drug.  Subjects 
may have multiple reasons for prematurely discontinuing study drug, but will be counted 
no more than once for the total ("Any Reason").

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8.1.4.2
Study Drug Exposure
Extent of exposure to study drug will be summarized for all subjects who received at least 
one dose of study drug in Study M16-244.  The duration (days) of study treatment will be 
summarized with the mean, standard deviation, median, Q1, Q3 and range.  The duration 
of treatment is defined as the difference between the dates of the first and last doses of the 
treatment plus 1 day.
8.1.5
Efficacy Analysis
The baseline for all efficacy analysis in this study will be the baseline in Study 1311.5. 
8.1.5.1
Efficacy Variable
Please see Section 5.3.3 for the list of all efficacy endpoints in this study.
A subject will be considered an ACR20/50/70 responder if compared to the baseline in 
Study 1311.5.
1.
The counts for both SJC (66 joints count) and TJC (68 joints count) have reduced 
by 20%/50%/70% or more; and
2.
At least three of the five remaining ACR core set measures show reduction of 
20%/50%/70% or more in:
a.
Patient's Assessment of PsA Pain Intensity (VAS)
b.
Patient's Global Assessment of Disease Activity (PtGA)
c.
Physician's Global Assessment of Disease Activity (PhGA)
d.
Patient's Assessment of Physical Function by Heath Assessment Questionnaire 
– Disability Index (HAQ-DI)
e.
High sensitivity C-reactive protein
The other efficacy endpoints will be defined in details in Statistical Analysis Plan (SAP). 

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8.1.5.2
Efficacy Analysis
The efficacy analyses will be conducted with the analysis set described in Section 8.1.1.
For binary endpoints, frequencies and percentages will be calculated with 95% confidence 
intervals at each post-baseline time point.  For the change from baseline measurement, the 
mean with 95% CI, standard deviation, median, Q1, Q3 and range will be reported at each 
post-baseline time point. 
8.1.5.3
Multiple Comparisons
Not applicable.
8.1.6
Safety Analysis
8.1.6.1
General Considerations
All subjects who receive at least one dose of study drug in this OLE study will be 
included in the safety analysis.
Incidence of adverse events, serious adverse events, premature discontinuation, and 
changes in vital signs, physical examination results, and clinical laboratory values will be 
analyzed for Study M16-244.
Treatment-emergent adverse events (TEAEs) will be tabulated by system organ class 
(SOC) and Preferred Term (PT).  
Mean change from baseline for laboratory and vital signs data will be summarized.  
Baseline for vital signs, physical examination results, and clinical laboratory results for 
subjects will be the data collected at the Week 0 visit immediately prior to study drug 
administration in Study 1311.5.
Missing safety data will not be imputed.

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8.1.6.2
Analysis of Adverse Events
8.1.6.2.1
Treatment-Emergent Adverse Events
AEs will be coded using MedDRA.  A TEAE is defined as an AE that began or worsened 
in severity after initiation of study drug.  AEs starting more than 140 days following the 
last dose of study drug will not be included in summaries of TEAEs.
As a general safety summary, the number and percentage of subjects experiencing TEAEs 
will be summarized for each treatment group for the following AE categories:
●
All TEAEs;
●
All severe TEAEs;
●
All reasonably possibly related TEAEs;
●
All SAEs;
●
Discontinuations due to TEAEs;
●
All TEAEs of special interest
●
Death.
Additional TEAEs may be considered for tabulation/summary based on recommendations 
from Clinical and Safety as deemed appropriate.
TEAEs will be summarized and presented by SOCs and PTs using MedDRA.  The SOCs 
will be presented in alphabetical order, and the
PTs will be presented in alphabetical order within each SOC.
TEAE will also be summarized by maximum severity and by maximum relationship.
The intensity grading of AEs will be performed according to Rheumatology Common 
Toxicity Criteria (RCTC) Version 2.0 developed by OMERACT.11  Intensity options are:
Grade 1
mild
Grade 2
moderate

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Grade 3
severe
Grade 4
life-threatening
The TEAEs of special interest currently include hepatic injury.
Listing of all SAEs, AEs leading to death, and TEAEs leading to study drug 
discontinuation and TEAE of special interest will be generated.
8.1.6.2.2
Serious Adverse Events and Death
Deaths and all SAEs will be presented in listing format.  In addition, SAEs will be 
summarized by MedRA SOC and PTs.
8.1.6.3
Analysis of Laboratory and Vital Signs
Changes from baseline in continuous laboratory, vital sign, and ECG parameters will be 
summarized with the mean, standard deviation and median by visit.
Vital signs and laboratory data will be described by statistical characteristics and 
frequency of abnormal values.  Frequencies and percentages of subjects with laboratory 
shifts from baseline to the final values using normal ranges to define categories (low, 
normal, high, and missing) will be summarized by the respective categories.  Values 
beyond the normal values will be listed.  Low or high laboratory values will also be 
flagged in the data listings.
Analysis details will be specified in the Statistical Analysis Plan.
8.1.7
Pharmacokinectic and Exposure-Response Analysis
Individual risankizumab plasma concentrations will be tabulated and summarized with 
appropriate statistical methods.  In addition, ADA titers will be tabulated for each subject 
at the respective study visits.  The percentage of subjects with ADA will be calculated.  
Data from this study may be combined with data from other risankizumab studies for the 
population pharmacokinetic and exposure-response analyses.  Population pharmacokinetic 

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and exposure-response analyses of only data from this study may not be conducted.  The 
following general methodology will be used for the population pharmacokinetic analysis.  
Population pharmacokinetic analyses of risankizumab will be performed using the actual 
sampling time relative to dosing.  Pharmacokinetic models will be build using a non-
linear mixed-effects modeling approach with NONMEM software (Version 7, or a higher 
version).  The structure of the starting pharmacokinetic model will be based on the 
pharmacokinetic analysis data from previous studies.  Apparent CL/F and apparent Vss/F 
of risankizumab will be the pharmacokinetic parameters of major interest in the 
NONMEM analyses.  If necessary, other parameters, including the parameters describing 
absorption characteristics, may be estimated if useful in the analysis.
The evaluation criteria described below will be used to examine the performance of 
different models:
1.
The objective function of the best model is significantly smaller than the alternative 
model(s).
2.
The observed and predicted concentrations from the preferred model are more 
randomly distributed across the line of unity (a straight line with zero intercept and 
a slope of one) than the alternative model(s).
3.
Visual inspection of model fits standard errors of model parameters and change in 
inter-subject and intra-subject error.
Once an appropriate base pharmacokinetic model (including inter- and intra-subject error 
structure) is developed, empirical Bayesian estimates of individual model parameters will 
be calculated by the posterior conditional estimation technique using NONMEM.  The 
relationship between these conditional estimates CL/F and Vss/F values with only 
potentially physiologically relevant or clinically meaningful covariates (such as ADA 
class subject age, sex, body weight, concomitant medications, possibly baseline 
inflammatory and disease markers) will be explored using stepwise forward selection 
method, or another suitable regression/smoothing method at a significance level of 0.05.  

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After identification of all relevant covariates, a stepwise backward elimination of 
covariates from the full model will be employed to evaluate the significance (at P < 0.005, 
corresponding to a decrease in objective function > 7.88 for one degree of freedom) of 
each covariate in the full model.
In general, all continuous covariates will be entered in the model, initially in a linear 
fashion, with continuous covariates centered on the median value.  Linear or non-linear 
relationships of primary pharmacokinetic parameters with various covariates may also be 
explored.
As appropriate, the effect of ADA on risankizumab pharmacokinetics and efficacy will be 
explored.  Relationships between exposure and clinical observations (efficacy or safety 
variables of interest) may be explored.
8.1.8
Interim Analysis
Not applicable.
8.1.9
Data Monitoring Committee
A data monitoring committee (DMC), independent of the Sponsor will be established to 
assess the progress of the clinical trials, including safety assessment at specified intervals, 
and to recommend to the Sponsor whether to continue, modify, or stop the trial.  The tasks 
and responsibilities of the DMC will be specified in the DMC Charter.  
8.1.10
CCVT Adjudication Committee
An independent adjudication committee, established for risankizumab development and 
used in the Study 1311.5 will continue adjudicating all observed cardio- and cerebro-
vascular events, and thrombotic events (CCVT) including major adverse cardiovascular 
events (MACE).  The events that are adjudicated and the adjudication process will be 
detailed in the CCVT Adjudication Committee Charter.

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8.2
Determination of Sample Size
Study 1311.5 will enroll approximately 180 subjects.  The sample size of Study M16-244 
will depend on how many subjects complete all doses of study medication and the 
Week 24 visit of Study 1311.5 and enroll in this OLE.  
9.0
Ethics
9.1
Independent Ethics Committee (IEC) or Institutional Review 
Board (IRB)
Good Clinical Practice (GCP) requires that the clinical protocol, any protocol 
amendments, the Investigator's Brochure, the informed consent and all other forms of 
subject information related to the study (e.g., advertisements used to recruit subjects) and 
any other necessary documents be reviewed by an Independent Ethics Committee 
(IEC)/Institutional Review Board (IRB).  The IEC/IRB will review the ethical, scientific 
and medical appropriateness of the study before it is conducted.  IEC/IRB approval of the 
protocol, informed consent and subject information and/or advertising, as relevant, will be 
obtained prior to the authorization of drug shipment to a study site.
Any amendments to this protocol will require IEC/IRB approval prior to implementation 
of any changes made to the study design.  The investigator will be required to submit, 
maintain and archive study essential documents according to ICH GCP.
Any serious adverse events that meet the reporting criteria, as dictated by local 
regulations, will be reported to both responsible Ethics Committees and Regulatory 
Agencies, as required by local regulations.  During the conduct of the study, the 
investigator should promptly provide written reports (e.g., ICH Expedited Reports, and 
any additional reports required by local regulations) to the IEC/IRB of any changes that 
affect the conduct of the study and/or increase the risk to subjects.  Written documentation 
of the submission to the IEC/IRB should also be provided to AbbVie.

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9.2
Ethical Conduct of the Study
The study will be conducted in accordance with the protocol, International Conference on 
Harmonization (ICH) guidelines, applicable regulations and guidelines governing clinical 
study conduct and the ethical principles that have their origin in the Declaration of 
Helsinki.  Responsibilities of the clinical investigator are specified in Appendix A.
9.3
Subject Information and Consent
The investigator or his/her representative will explain the nature of the study to the 
subject, and answer all questions regarding this study.  Prior to any study-related 
procedures at the Week 0 visit being performed on the subject, the informed consent 
statement will be reviewed and signed and dated by the subject, the person who 
administered the informed consent, and any other signatories according to local 
requirements.  A copy of the informed consent form will be given to the subject and the 
original will be placed in the subject's medical record.  An entry must also be made in the 
subject's dated source documents to confirm that informed consent was obtained prior to 
any study-related procedures and that the subject received a signed copy.
Information regarding incentives for subjects and information regarding provisions for 
treating and/or compensating subjects who are harmed as a consequence of participation 
in the study can be found in the informed consent form.
9.3.1
Informed Consent Form and Explanatory Material
Prior to the performance of any study specific procedures, including discontinuation of 
any protocol prohibited medications, the investigator or representative will explain the 
nature of study procedures and the study to the subject and if applicable per local 
requirements the subject's legal representative, and all questions regarding the study will 
be answered.  The informed consent form will be reviewed and consent to participate 
documented by dated signature of the representative and the person administering the 
informed consent. 
See Appendix D for Japan specific requirements.

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10.0
Source Documents and Case Report Form 
Completion
10.1
Source Documents
Source documents are defined as original documents, data and records.  This may include 
hospital records, clinical and office charts, laboratory data/information, subjects' diaries or 
evaluation checklists, pharmacy dispensing and other records, recorded data from 
automated instruments, microfiches, photographic negatives, microfilm or magnetic 
media, and/or x-rays.  Data collected during this study must be recorded on the 
appropriate source documents.
Due to the nature of an open label extension study, data that is common to both 
Study 1311.5 and Study M16-244 studies may be shared.  AbbVie will provide instruction 
regarding entry of this data.
The investigator(s)/institution(s) will permit study-related monitoring, audits, IEC/IRB 
review, and regulatory inspection(s), providing direct access to source data documents.
10.2
Case Report Forms
Case report forms (CRF) must be completed for each subject enrolled in this study.  These 
forms will be used to transmit information collected during the study to AbbVie and 
regulatory authorities, as applicable.  The CRF data for this study are being collected with 
an electronic data capture (EDC) system called Rave® provided by the technology vendor 
Medidata Solutions Incorporated, NY, USA.  The EDC system and the study-specific 
electronic case report forms (eCRFs) will comply with Title 21 CFR Part 11.  The 
documentation related to the validation of the EDC system is available through the 
vendor, Medidata, while the validation of the study-specific eCRFs will be conducted by 
AbbVie and will be maintained in the Trial Master File at AbbVie.
The investigator will document subject data in his/her own subject files.  These subject 
files will serve as source data for the study.  All eCRF data required by this protocol will 

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be recorded by investigative site personnel in the EDC system.  All data entered into the 
eCRF will be supported by source documentation.
The investigator or an authorized member of the investigator's staff will make any 
necessary corrections to the eCRF.  All change information, including the date and person 
performing the corrections, will be available via the audit trail, which is part of the EDC 
system.  For any correction, a reason for the alteration will be provided.  The eCRFs will 
be reviewed periodically for completeness, legibility, and acceptability by AbbVie 
personnel (or their representatives).  AbbVie (or their representatives) will also be allowed 
access to all source documents pertinent to the study in order to verify eCRF entries.  The 
principal investigator will review the eCRFs for completeness and accuracy and provide 
his or her electronic signature and date to eCRFs as evidence thereof.
Medidata will provide access to the EDC system for the duration of the trial through a 
password-protected method of internet access.  Such access will be removed from 
investigator sites at the end of the site's participation in the study.  Data from the EDC 
system will be archived on appropriate data media (CD-ROM, etc.) and provided to the 
investigator at that time as a durable record of the site's eCRF data.  It will be possible for 
the investigator to make paper printouts from that media.
Patient Reported Outcome (PRO) data must be completed for each subject enrolled in this 
study.  The subject will enter patient reported data responses on paper CRF provided by 
AbbVie.  Investigative Site personnel will enter the subject's responses from the paper 
CRFs into the appropriate CRFs in the EDC system.  Any corrections to the paper CRFs 
can only be made by the subject, and will include the date and person (initials) performing 
the corrections.  All changed information in the CRF, including the date and person 
performing the corrections, will be available via the audit trail, which is the part of the 
EDC system.
The following PROs will be used in this study:
●
SF-36 

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●
BASDAI
●
HAQ-DI
●
FACIT-F
●
PtGA
●
Patient Assessment of PsA Pain Intensity (VAS)
11.0
Data Quality Assurance
Computer logic and manual checks will be created to identify items such as inconsistent 
study dates.  Any necessary corrections will be made to the eCRF.
Prior to the initiation of the study, a meeting will be held with AbbVie personnel, the 
investigators and appropriate site personnel.  This meeting will include a detailed 
discussion of the protocol, performance of study procedures, CRF and Subject Diary 
completion, and specimen collection methods.  The AbbVie monitor will monitor each 
site throughout the study. 
All data hand entered in the database will be verified at AbbVie.  Any discrepancies will 
be reviewed against the CRF and corrected on-line.  After completion of the entry 
process, computer logic checks will be run to check for such items as inconsistent study 
dates.  Any necessary corrections will be made to the database via addenda.
Routine hematology, serum chemistry and serology, and urinalysis will be conducted 
using a central laboratory.  The data from these analyses will be electronically transferred 
from the central laboratory to the study database.
12.0
Use of Information
All information concerning specify study drug and AbbVie operations, such as AbbVie 
patent applications, formulas, manufacturing processes, basic scientific data, or 
formulation information, supplied by AbbVie and not previously published is considered 
confidential information.  The information developed during the conduct of this clinical 

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study is also considered confidential and will be used by AbbVie in connection with the 
development of specify study drug.  This information may be disclosed as deemed 
necessary by AbbVie to other clinical investigators, other pharmaceutical companies, and 
to governmental agencies.  To allow for the use of the information derived from this 
clinical study and to ensure complete and thorough analysis, the investigator is obligated 
to provide AbbVie with complete test results and all data developed in this study and to 
provide direct access to source data/documents for trial-related monitoring, audits, 
IEC/IRB review and regulatory inspection.  This confidential information shall remain the 
sole property of AbbVie, shall not be disclosed to others without the written consent of 
AbbVie, and shall not be used except in the performance of this study.  The investigator 
will maintain a confidential subject identification code list of all subjects enrolled in the 
study (by name and subject number).  This list will be maintained at the site and will not 
be retrieved by AbbVie.
13.0
Completion of the Study
The investigator will conduct the study in compliance with this protocol and complete the 
study within the timeframe specified in the contract between the investigator and AbbVie.  
Continuation of this study beyond this date must be mutually agreed upon in writing by 
both the investigator and AbbVie.  The investigator will provide a final report to the 
IEC/IRB following conclusion of the study, and will forward a copy of this report to 
AbbVie or their representative.
The investigator must retain any records related to the study according to local 
requirements.  If the investigator is not able to retain the records, he/she must notify 
AbbVie to arrange alternative archiving options.
AbbVie will select the signatory investigator from the investigators who participate in the 
study.  Selection criteria for this investigator will include level of participation as well as 
significant knowledge of the clinical research, investigational drug and study protocol.  
The signatory investigator for the study will review and sign the final study report in 

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accordance with the European Agency for the Evaluation of Medicinal Products (EMEA) 
Guidance on Investigator's Signature for Study Reports.
The EOS is defined as the date of the last subject's last scheduled visit or the date of the 
Follow-up Phone Call, whichever is later, see Appendix C.
See Appendix D for Japan specific requirements.

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14.0
Investigator's Agreement
1.
I have received and reviewed the Investigator's Brochure for risankizumab.
2.
I have read this protocol and agree that the study is ethical.
3.
I agree to conduct the study as outlined and in accordance with all applicable 
regulations and guidelines.
4.
I agree to maintain the confidentiality of all information received or developed in 
connection with this protocol.
5.
I agree that all electronic signatures will be considered the equivalent of a 
handwritten signature and will be legally binding.
Protocol Title: 
A Phase 2, Single-Arm, Open-Label Extension Study to Investigate 
the Safety with Risankizumab in Psoriatic Arthritis Subjects Who 
Have Completed Week 24 Visit of Study 1311.5
Protocol Date:
23 May 2018
Signature of Principal Investigator
Date
Name of Principal Investigator (printed or typed)

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15.0
Reference List
15.1
Published References
1.
Ware JE, Kosinski M, Keller SD, editors.  SF-36 Physical and Mental Health 
Summary Scales:  A User's Manual.  3rd, revised ed.  Boston:  The Health Institute, 
New England Medical Center; 1994.
2.
Felson DT, Anderson JJ, Boers M, et al.  American College of Rheumatology.  
Preliminary definition of improvement in rheumatoid arthritis.  Arthritis Rheum.  
1995;38(6):727-35.
3.
Fredriksson T, Pettersson U.  Severe psoriasis--oral therapy with a new retinoid.  
Dermatologica.  1978;157(4):238-44.  
4.
Ware JE, editor.  SF-36 Health Survey:  Manual and Interpretation Guide.  Boston:  
The Health Institute, New England Medical Center; 1993.  
5.
van Gestel AM, Haagsma CJ, van Riel PLCM.  Validation of rheumatoid arthritis 
improvement criteria that include simplified joint counts.  Arthritis Rheum.  
1998;41(10):1845-50.  
6.
Mease PJ, Gladman DD, Ritchlin CT, et al.  Adalimumab Effectiveness in Psoriatic 
Arthritis Trial Study Group.  Adalimumab for the treatment of patients with 
moderately to severely active psoriatic arthritis:  results of a double-blind, 
randomized, placebo-controlled trial.  Arthritis Rhem.  2005;52(10):3279-89.  
7.
Yellen SB, Cella DF, Webster K, et al.  Measuring fatigue and other anemia-related 
symptoms with the Functional Assessment of Cancer Therapy (FACT) 
measurement system.  J Pain Symptom Manage.  1997;13(2);63-74.  
8.
Webster K, Cella D, Yost K.  The Functional Assessment of Chronic Illness 
Therapy (FACIT) Measurement System:  properties, applications, and 
interpretation.  Health Qual Life Outcomes.  2003;1:79.  
9.
Nestle FO, Kaplan DH, Barker J.  Psoriasis.  N Engl J Med.  2009;361(5):496-509.  

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10.
Sherlock JP, Joyce-Shaikh B, Turner SP, et al.  IL-23 induces spondyloarthropathy 
by acting on ROR-γt+ CD3+CD4-CD8- entheseal resident T cells.  Nat Med.  
2012;18(7):1069-76.
11.
Woodworth T, Furst DE, Alten R, et al.  Standardizing assessment and reporting of 
adverse effects in rheumatology clinical trials II:  the Rheumatology Common 
Toxicity Criteria v.2.0.  J Rheumatol.  2007;34(6):1401-14.  
12.
Gottlieb A, Korman NJ, Gordon KB, et al.  Guidelines of care for the management 
of PsO and psoriatic arthritis.  Section 2.  Psoriatic arthritis:  overview and 
guidelines of care for treatment with an emphasis on the biologics.  J Am Acad 
Dermatol.  2008;58(5):851-64.  
13.
Frleta M, Siebert S, McInnes IB.  The interleukin-17 pathway in psoriasis and 
psoriatic arthritis:  disease pathogenesis and possibilities of treatment.  Curr 
Rheumatol Rep.  2014;16(4):414.  
14.
Filer C, Ho P, Smith RL, et al.  Investigation of association of the IL12B and 
IL23R genes with psoriatic arthritis.  Arthritis Rheum.  2008;58(12):3705-09.  
15.
Zachariae H, Zachariae R, Blomqvist K, et al.  Quality of life and prevalence of 
arthritis reported by 5,795 members of the Nordic PsO Associations.  Data from the 
Nordic Quality of Life Study.  Acta Derm Venereol.  2002;82(2):108-13.  
16.
Prey S, Paul C, Bronsard V, et al.  Assessment of the risk of psoriatic arthritis in 
patients with plaque PsO:  a systematic review of the literature.  J Eur Acad 
Dermatol Venereol.  2010;24 (Suppl 2):31-5.  
17.
Celis R, Planell N, Fernández-Sueiro JL, et al.  Synovial cytokine expression in 
psoriatic arthritis and associations with lymphoid neogenesis and clinical features.  
Arthritis Res Ther.  2012;14 (2); R93.  
18.
Gladman DD, Antoni C, Mease P, et al.  Psoriatic arthritis:  epidemiology, clinical 
features, course, and outcome.  Ann Rheum Dis.  2005;64 Suppl 2:ii14-7.  
19.
van der Heijde D, Sharp J, Wassenberg S, et al.  Psoriatic arthritis imaging:  a 
review of scoring methods.  Ann Rheum Dis.  2005;64 (Suppl 2):ii61-4.  

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20.
Ciocon DH, Kimball AB.  Psoriasis and psoriatic arthritis:  separate or one and the 
same?  Br J Dermatol.  2007;157(5):850-60.  
21.
Yawalkar N, Tscharner GG, Hunger RE, et al.  Increased expression of IL-12p70 
and IL-23 by multiple dendritic cell and macrophage subsets in plaque psoriasis.  
J Dermatol Sci.  2009;54(2):99-105.  
22.
Liu Y, Helms C, Liao W, et al.  A genome-wide association study of psoriasis and 
psoriatic arthritis identifies new disease loci.  PLoS Genet.  2008;4(3):e1000041.  
23.
Koshy PJ, Henderson N, Logan C, et al.  Interleukin 17 induces cartilage collagen 
breakdown: novel synergistic effects in combination with proinflammatory 
cytokines.  Ann Rheum Dis.  2002;61(8):704-13. 
24.
Mease P.  Psoriatic arthritis and spondyloarthritis assessment and management 
update.  Curr Opin Rheumatol.  2013;25(3):287-96.  
25.
Coates LC, Fransen J, Helliwell PS.  Defining minimal disease activity in psoriatic 
arthritis:  a proposed objective target for treatment.  Ann Rheum Dis.  
2010;69(1):48-53.  
26.
Healy PJ, Helliwell PS.  Measuring clinical enthesitis in psoriatic arthritis:  
assessment of existing measures and development of an instrument specific to 
psoriatic arthritis.  Arthritis Care Res.  2008;59(5):686-91.  
27.
Bruce B, Fries JF.  The Stanford Health Assessment Questionnaire:  a review of its 
history, issues, progress, and documentation.  J Rheumatol.  2003;30(1):167-78.  
28.
The Health Assessment Questionnaire (HAQ) and the improved HAQ (formerly 
called the PROMIS HAQ) (revised June 2009).  Stanford:  Stanford University 
School of Medicine, Division of Immunology & Rheumatology.  2009.  Available 
from:  
http://aramis.stanford.edu/downloads/HAQ%20Instructions%20(ARAMIS)%206-
30-09.pdf.  Accessed on:  15 July 2015.  
29.
Maksymowych WP, Mallon C, Morrow S, et al.  Development and validation of 
the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index.  
Ann Rheum Dis.  2009;68(6):948-53.  

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30.
Helliwell PS, Firth J, Ibrahim GH, et al.  Development of an assessment tool for 
dactylitis in patients with psoriatic arthritis.  J Rheumatol.  2005;32(9):1745-50.  
31.
Cassell SE, Bieber JD, Rich P, et al.  The modified nail psoriasis severity index:  
validation of an instrument to assess psoriatic nail involvement in patients with 
psoriatic arthritis.  J Rheumatol.  2007;34(1):123-9.  
32.
Langley RGB, Feldman SR, Nyirady J, et al.  The 5-point Investigator's Global 
Assessment (IGA) scale:  a modified tool for evaluating plaque psoriasis severity in 
clinical trials.  J Dermatol Treat.  2015;26(1):23-31.
33.
Garrett S, Jenkinson T, Kennedy LG, et al.  A new approach to defining disease 
status in ankylosing spondylitis:  the Bath Ankylosing Spondylitis Disease Activity 
Index.  J Rheumatol.  1994;21(12):2286-91.
34.
Cella D, Yount S, Sorensen M, et al.  Validation of the Functional Assessment of 
Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients 
with rheumatoid arthritis.  J Rheumatol.  2005;32(5);811-9.
35.
van Gestel AM, Prevoo ML, van 't Hof MA, et al.  Development and validation of 
the European League Against Rheumatism response criteria for rheumatoid 
arthritis.  Comparison with the preliminary American College of Rheumatology 
and the World Health Organization/International League Against Rheumatism 
Criteria.  Arthritis Rheum.  1996;39(1):34-40.
15.2
Unpublished References
36.
Investigator's Brochure BI 655066, Psoriasis, Crohn's Disease, Ankylosing 
Spondylitis, 1311.P1/1311.P2/1311.P3.  (c02161217)
37.
Dorleacq N, Steimle-Goerttler C, Bai X, et al.  Safety, tolerability, efficacy, 
pharmacokinetics, and pharmacodynamics of single rising i.v. (Stage 1) and s.c. 
(Stage 2) doses of BI 655066 in male and female patients with moderate to severe 
psoriasis (randomised, double-blind, placebo-controlled within dose groups) 
(Trial 1311.1).  26 Mar 2015.  (c02434648)

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38.
Summary report of interim analysis at Week 48 (Trial 1311.2).  05 May 2015.  
(c03272682)

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Appendix A.
Responsibilities of the Clinical Investigator
Clinical research studies sponsored by AbbVie are subject to the Good Clinical Practices 
(GCP) and local regulations and guidelines governing the study at the site location.  In 
signing the Investigator Agreement in Section 14.0 of this protocol, the investigator is 
agreeing to the following:
1.
Conducting the study in accordance with the relevant, current protocol, making 
changes in a protocol only after notifying AbbVie, except when necessary to 
protect the safety, rights or welfare of subjects.
2.
Personally conducting or supervising the described investigation(s).
3.
Informing all subjects, or persons used as controls, that the drugs are being used for 
investigational purposes and complying with the requirements relating to informed 
consent and ethics committees (e.g., independent ethics committee [IEC] or 
institutional review board [IRB]) review and approval of the protocol and 
amendments.
4.
Reporting adverse experiences that occur in the course of the investigation(s) to 
AbbVie and the site director.
5.
Reading the information in the Investigator's Brochure/safety material provided, 
including the instructions for use and the potential risks and side effects of the 
investigational product(s).
6.
Informing all associates, colleagues, and employees assisting in the conduct of the 
study about their obligations in meeting the above commitments.
7.
Maintaining adequate and accurate records of the conduct of the study, making 
those records available for inspection by representatives of AbbVie and/or the 
appropriate regulatory agency, and retaining all study-related documents until 
notification from AbbVie.
8.
Maintaining records demonstrating that an ethics committee reviewed and 
approved the initial clinical investigation and all amendments.

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9.
Reporting promptly, all changes in the research activity and all unanticipated 
problems involving risks to human subjects or others, to the appropriate individuals 
(e.g., coordinating investigator, institution director) and/or directly to the ethics 
committees and AbbVie.
10.
Following the protocol and not make any changes in the research without ethics 
committee approval, except where necessary to eliminate apparent immediate 
hazards to human subjects.

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Appendix B.
List of Protocol Signatories
Name
Title
Functional Area
Clinical
Clinical
Statistics
Pharmacokinetics
Clinical 
Medical Writing

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Appendix C.
Study Activities
Treatment
Follow-Up
V1
V2
V3
V4
V5 
(EOT/Early 
EOTs)
V6
EOS (EOT/Early 
EOT + 16 Weeks)
Follow-up 
Phone Call
Week
0a
4t
12
24
36
48
52
56
Day
1
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
392 ± 4
Informed Consentb
X
Inclusion/exclusion criteria
X
Medical/Surgical Historyc
Xa
Patient's Global Assessment of 
Disease Activity (VAS) (PtGA)d
Xa
X
X
X
X
X
X
Patient's Assessment of PsA Pain 
Intensity (VAS)d
Xa
X
X
X
X
X
X
HAQ-DId
Xa
X
X
X
X
X
X
BASDAId,m
Xa
X
X
X
X
SF-36v2d
Xa
X
X
X
X
X
X
FACIT-Fd
Xa
X
X
X
Vital Signse
Xa
X
X
X
X
X
X
ECGe
Xa
X
X
X
Physical Exame
(c = complete, t = targeted)
X-ca
X-t
X-t
X-t
X-t
X-t
X-c
Concomitant Therapyf
Xa
X
X
X
X
X
X
X

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Treatment
Follow-Up
V1
V2
V3
V4
V5 
(EOT/Early 
EOTs)
V6
EOS (EOT/Early 
EOT + 16 Weeks)
Follow-up 
Phone Call
Week
0a
4t
12
24
36
48
52
56
Day
1
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
392 ± 4
Adverse Event Assessmentg
Xa
X
X
X
X
X
X
X
Tender Joint Count (TJC 68)h
Xa
X
X
X
X
X
X
Swollen Joint Count (SJC 66)h
Xa
X
X
X
X
X
X
PASIh,u
Xa
X
X
X
X
X
X
BSAh
Xa
X
X
X
X
X
X
Static Physician's Global 
Assessment for Psoriasis 
(sPGA)h,u
Xa
X
X
X
X
X
X
Physician's Global Assessment of 
Disease Activity (PhGA) (VAS)h
Xa
X
X
X
X
X
X
Leeds Dactylitis Index (LDI)h
Xa
X
X
X
X
X
Leeds Enthesitis Index (LEI)h
Xa
X
X
X
X
X
SPARCCh
Xa
X
X
X
X
X
mNAPSIh
Xa
X
X
X
X
X
mTSS (X-ray)i
X
X
Pregnancy Testj
Xa
X
X
X
X
X
X
Safety Labs (Chemistry, 
Hematology, Urinalysis)k,v
Xa
X
X
X
X
X
X

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Treatment
Follow-Up
V1
V2
V3
V4
V5 
(EOT/Early 
EOTs)
V6
EOS (EOT/Early 
EOT + 16 Weeks)
Follow-up 
Phone Call
Week
0a
4t
12
24
36
48
52
56
Day
1
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
392 ± 4
hsCRP for DASk
Xa
X
X
X
X
X
X
Blood Sample for PKk,l
Xa
X
X
X
X
X
X
Blood Sample for ADA Assayk,l
Xa
X
X
X
X
X
X
TB screeningk,n
X
Xr
Local tolerabilityo
X
X
X
X
X
Study drug administration
X
Xp
(additional)
X
X
X
Monitoring for hypersensitivity 
reactionq
X
X
X
X
X
Conclusion of Subject 
participation
X
a.
For subjects rolling over from Study 1311.5 to the OLE (Study M16-244) with ≤ 4 day delay, these procedures do not need to be repeated.  Results assessed at the Week 24 
visit of Study 1311.5 will serve as V1 (Week 0) visit results for Study M16-244.  Subjects initiating the OLE with a delay of > 4 days and ≤ 8 weeks from completion of 
Study 1311.5 Week 24 visit will need to complete all activities for V1.  If a subject enrolls into the OLE (Study M16-244), participation in Study 1311.5 is completed and the 
early completion of the Study 1311.5 is documented (EOS).  All procedures of Study 1311.5 trial at Week 24 should be completed prior to the start of the Study M16-244 
trial.
b.
To be completed prior to initiation of Study M16-244 procedures.
c.
Transcribe medical history from Study 1311.5 and record any updates.
d.
Subject to complete PROs in the order listed, before any other visit assessments or treatments and, if possible, before any interaction with the investigator or other members of 
the study team.  

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e.
A symptom directed physical exam should be performed when necessary and if needed for physician assessments/questionnaires.  Complete physical examination will include 
vital sign assessment and general appearance as well as evaluation of all organ systems.  Targeted physical examination will include vital sign assessment and evaluation of 
organ systems associated with AE(s) symptoms or laboratory abnormalities.  Clinically relevant abnormal findings will be reported as baseline conditions or AEs.
f.
For subjects rolling over from Study 1311.5 to the OLE without any delay, concomitant medication ending prior to first dose in Study M16-244 will be recorded in preceding 
Study 1311.5.  Medications ongoing from preceding Study 1311.5 after first dose in Study M16-244 will be recorded in Study M16-244.
g. 
For subjects rolling over from Study 1311.5 to the OLE Adverse Events ending prior to completion of Study M16-244 ICF will be recorded in preceding Study 1311.5.  
Adverse events occurring after completing Study M16-244 ICF will be recorded in the eCRFs of Study M16-244.  
h.
Complete clinical assessment prior to lab sample collection and study drug administration.
i.
Subjects who prematurely discontinue from the trial will not be required to collect x-rays at each designated time point, unless they received a dose within the 16 weeks prior 
to the scheduled time point.
j.
Urine pregnancy testing will be done locally and prior to administration of study drug at all dosing visits and at each follow-up visit.  Any subject with a positive urine 
pregnancy test must have a negative serum test performed at the central laboratory prior to enrollment or continuation in the study.
k.
Complete lab sample collection after PRO, clinical assessments and before study drug administration.
l.
In the event of a suspected hypersensitivity reaction or other systemic post-dose reaction, a PK/ADA and urine samples will be collected once within 24 hours of the reaction.
m.
For subjects that presented with inflammatory spondylitis at baseline to Study 1311.5 based on investigator judgment.
n.
QuantiFERON® TB test or PPD (purified protein derivative) skin test will be performed according to local labelling for comparator products.  If the result is positive, subjects 
may continue in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis.  If 
presence of latent tuberculosis is established, then tuberculosis treatment may be deferred until completion of the trial according to clinical judgment of investigator and local 
country guidelines and it is also necessary to report it as an adverse event in the source documents and eCRFs.  If the subject is diagnosed with active tuberculosis, the subject 
should not receive any further study drug and follow the premature treatment discontinuation procedure (Early EOT visit) in Section 5.4.1.
o.
Local tolerability at the administration site of the previous subcutaneous injection will be assessed by the investigator according to "swelling," "induration," "heat," "redness," 
"pain," or "other findings."  Any abnormal findings at the injection site during the current visit will be reported as AEs.
p.
The additional dose is given in the event that the subject has not achieved a protocol defined response (defined as an improvement in tender and swollen joint count of ≥ 20% 
compared with the baseline in Study 1311.5) and the investigator believes this may be beneficial to the subject.
q.
Subjects should be closely monitored for signs and symptoms of hypersensitivity reactions for approximately 2 hours following the first administration, and for approximately 
1 hour following subsequent doses, of study drug.  Hypersensitivity reactions should be treated according to medical standards.
r.
Required at EOS visit only for subjects that prematurely discontinue prior to Week 24 visit.
s.
For subjects that prematurely discontinue, study drug will not be given at the early EOT visit.
t.
At Week 4 visit, if the additional dose is not administered all other referenced procedures will be completed during this visit.

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u.
PASI and sPGA are assessed in patients with ≥ 3% BSA of psoriatic plaques at baseline in Study 1311.5 and/or current visit.
v.
Subject to attend study visits in a fasted state (8 hours no food and only water).  If a patient comes in non-fasted where a fasting condition is required, the visit should be 
performed, and the non-fasted condition documented on the laboratory requisition.
See Appendix D for Japan specific requirements.

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Appendix D.
Local Requirements
Local Requirements – Japan
Section 5.3.1.1:  Study Procedures
Clinical Laboratory Tests
eGFR (estimated by CKD-EPI Japan formula)
Tuberculosis Screening
All subjects will be tested for TB by either the QuantiFERON-TB Gold Test (or 
equivalent) or a TB Skin Test or equivalent most commonly the Purified Protein 
Derivative (PPD) at the Week 24.  If premature discontinuation occurs prior to Week 24 
visit TB testing should occur at EOS visit as specified in Appendix C.  
A TB Skin Test or equivalent should be utilized only when a QuantiFERON®-TB Gold 
Test is not possible for any reason (unless both tests are required per local guidelines).  
●
QuantiFERON®-TB Gold Test will be analyzed by the central laboratory 
(QuantiFERON test is preferred over TB Skin Test).
●
If the QuantiFERON®-TB Gold Test is NOT possible (or if both the 
QuantiFERON®-TB Gold Test and the PPD Skin Test are required per local 
guidelines) the PPD Skin Test will be performed according to standard clinical 
practice.  
●
The PPD Skin Test should be read by a licensed healthcare professional 
between 48 and 72 hours after administration.  A subject who does not return 
within 72 hours will need to be rescheduled for another skin test.  
●
The reaction will be measured in millimeters (mm) of induration and 
induration ≥ 5 mm is considered a positive reaction.  The absence of induration 
will be recorded as "0 mm" not "negative."  
●
If PPD and/or the QuantiFERON®-TB Gold test (or IGRA equivalent) is 
positive, or if there is a repeat indeterminate QuantiFERON®-TB Gold test (or 
IGRA equivalent) upon retesting, subjects may continue in the study if further 

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work up (according to local practice/guidelines) establishes conclusively that 
the subject has no evidence of active tuberculosis.  
●
If the subject is diagnosed with active tuberculosis, the subject should not 
receive any further study drug and follow the premature treatment 
discontinuation procedure (Early EOT visit) in Section 5.4.1. 
●
If presence of latent tuberculosis is established treatment should be 
initiated and maintained according to local country guidelines.  It is also 
necessary to report it as an adverse event in the source documents and eCRFs.  
●
If subject is known to have a positive QuantiFERON®-TB Gold or PPD test in 
Study 1311.5 Screening period do not repeat in this study. 
●
Subjects who have had an ulcerating reaction to the TB Skin Test in the past
should not be re-exposed and should not be tested by a PPD skin test.
In the case of a tuberculosis-related adverse event, a supplemental case report form that 
provides additional information is be completed by the investigator or designee.
Section 7.0: Protocol Deviations
AbbVie does not allow intentional/prospective deviations from this protocol unless when 
necessary to eliminate an immediate hazard to study subjects.  The principal investigator 
is responsible for complying with all protocol requirements, and applicable global and 
local laws regarding protocol deviations.  If a protocol deviation occurs (or is identified) 
after a subject has been enrolled, the principal investigator is responsible for notifying 
Independent Ethics Committee (IEC)/Independent Review Board (IRB) regulatory 
authorities (as applicable), and the following AbbVie Clinical Monitor(s):

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Primary Contact:
Alternate Contact:
Such contact must be made as soon as possible to permit a review by AbbVie to 
determine the impact of the deviation on the subject and/or the study.
In Japan, the Investigator will record all protocol deviations in the appropriate 
medical records at site.
Section 9.3.1 Informed Consent Form and Explanatory Material
Prior to the performance of any study specific procedures, including discontinuation of 
any protocol prohibited medications, the investigator or representative will explain the 
nature of study procedures and the study to the subject and if applicable per local 
requirements the subject's legal representative, and all questions regarding the study will 
be answered.  The informed consent form will be reviewed and consent to participate 
documented by dated signature of the representative and the person administering the 
informed consent. 
In Japan, the principal investigator will prepare the consent form and explanatory 
material required to obtain subject's consent to participate in the study with the 
cooperation of the sponsor and will revise these documents as required.  The 
prepared or revised consent forms and explanatory material will be submitted to the 
sponsor.  Approval of the IRB will be obtained prior to use in the study.

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Section 9.3.2:  Revision of the Consent Form and Explanatory Material
In Japan, when important new information related to the subject's consent becomes 
available, the principal investigator will revise the consent form and explanatory material 
based on the information without delay and will obtain the approval of the IRB prior to 
use in the study.  The investigator will provide the information, without delay, to each 
subject already participating in the study, and will confirm the intention of each subject to 
continue the study or not.  The investigator shall also provide a further explanation using 
the revised form and explanatory material and shall obtain written consent from each 
subject of their own free will to continue participating in the study.
Section 13.0:  Completion of the Study
The investigator will conduct the study in compliance with this protocol and complete the 
study within the timeframe specified in the contract between the investigator (Director of 
the Site in Japan) and AbbVie.  Continuation of this study beyond this date must be 
mutually agreed upon in writing by both the investigator (Director of the Site in Japan)
and AbbVie.  The investigator will provide a final report to the IEC/IRB following 
conclusion of the study, and will forward a copy of this report to AbbVie or their 
representative.
The investigator (Director of the Site in Japan) must retain any records related to the 
study according to local requirements.  If the investigator (Director of the Site in Japan)
is not able to retain the records, he/she must notify AbbVie to arrange alternative 
archiving options.
AbbVie will select the signatory investigator from the investigators who participate in the 
study.  Selection criteria for this investigator will include level of participation as well as 
significant knowledge of the clinical research, investigational drug and study this 
protocol.  The signatory investigator for the study will review and sign the final study 
report in accordance with the European Agency for the Evaluation of Medicinal Products 
(EMEA) Guidance on Investigator's Signature for Study Reports.

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The end-of-study is defined as the date of the last subject's last visit.
Appendix C:  Study Activities Table
Treatment
Follow-Up
V1
V2
V3
V4
V5 
(EOT/Early 
EOT)
V6
EOS 
(EOT/Early 
EOT + 
16 Weeks)
Follow-up 
Phone 
Call
Week
0
4
12
24
36
48
52
56
Day
1 ± 4
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
365 ± 4
HBV 
DNA*
X
X
X
*
If subject had positive Hepatitis B Core Antibody or Hepatitis B Surface Antibody in Study 1311.5 and the reflex 
Hepatitis B virus DNA quantification level was undetectable at screening the HBV DNA level must be monitored 
at least every 6 months.
In the case of a tuberculosis-related adverse event, a supplemental case report form that 
provides additional information is be completed by the investigator or designee.
Local Requirements – Germany
Section 5.3.1.1 Study Procedures – X-Ray Assessments
The modified Total Sharp Score (mTSS) method, including distal interphalangeal joints, 
will be used to evaluate radiographic evidence of damage.19  X-rays of hands, wrists and 
feet.  The x-rays will be performed at two time points (Weeks 24 and 48, detailed in 
Appendix C).  Images will be read centrally for each subject in a random order and 
without knowledge of time point or subject identity.  Subjects who prematurely 
discontinue from study drug will not be required to collect x-rays at each designated time 
point, unless they received a dose within the 16 weeks prior to the scheduled time point.
For subjects who have had an X-Ray performed within 2 weeks before the scheduled 
protocol X-ray assessment, no additional X-Rays should be performed.

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Local Requirements – France
Section 5.2.1 Inclusion Criterion 2
Women of childbearing potential must agree to use at least one of the following methods 
of contraception throughout the study including 20 weeks after the last study drug dose is 
given:
●
combined (estrogen and progestogen containing) hormonal birth control (oral, 
intravaginal, transdermal) associated with inhibition of ovulation initiated at 
least one month prior to study participation
●
progestogen-only hormonal birth control (oral, injectable, implantable) 
associated with inhibition of ovulation initiated at least one month prior to 
study participation
●
bilateral tubal occlusion/ligation
●
intrauterine device (IUD) 
●
intrauterine hormone-releasing system (IUS)
●
Vasectomized sexual partner(s) (the vasectomized partner should have 
received medical assessment of the surgical success and is the sole sexual 
partner of the trial participant). 
●
True abstinence:  Refraining from heterosexual intercourse when this is in line 
with the preferred and usual lifestyle of the subject (periodic abstinence 
[e.g., calendar, ovulation, symptothermal, post-ovulation methods] and 
withdrawal are not acceptable).
Women of childbearing potential are defined as having experienced menarche and are: 
●
not postmenopausal (12 months with no menses without an alternative medical 
cause) 
●
not permanently sterilized (e.g., hysterectomy, bilateral oophorectomy or 
bilateral salpingectomy). 

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Section 5.2.2 Exclusion Criterion 1
1.
Female subject who is pregnant, breastfeeding or is considering becoming pregnant 
during study participation, including 20 weeks after the last dose of study drug is 
given.
Section 5.2.4 – Contraception Recommendations and Pregnancy
Female subjects of childbearing potential must be ready and able to use highly effective 
methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% 
per year when used consistently and correctly.  Or subjects must have only vasectomized 
sexual partner(s), or be abstinent.  The method chosen must be practiced throughout the 
study including 20 weeks after the last dose of study drug is given.
Women of childbearing potential are defined as having experienced menarche and are:
●
not postmenopausal (12 months with no menses without an alternative medical 
cause) 
●
not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral 
oophorectomy or bilateral salpingectomy).
The following is a list of accepted contraception methods: 
●
combined (estrogen and progestogen containing) hormonal birth control (oral, 
intravaginal, transdermal) associated with inhibition of ovulation initiated at 
least 1 month prior to study participation
●
progestogen-only hormonal birth control associated with inhibition of 
ovulation initiated at least one month prior to study participation
●
bilateral tubal occlusion/ligation
●
intrauterine device (IUD) 
●
intrauterine hormone-releasing system (IUS)

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●
Vasectomized sexual partner(s) (the vasectomized partner should have 
received medical assessment of the surgical success and is the sole sexual 
partner of the trial participant). 
●
True abstinence:  Refraining from heterosexual intercourse when this is in line 
with the preferred and usual lifestyle of the subject (periodic abstinence 
[e.g., calendar, ovulation, symptothermal, post-ovulation methods] and 
withdrawal are not acceptable).
In addition, both female subjects of childbearing potential and male subjects with female 
partners of childbearing potential, taking MTX as background medication, must follow 
the national regulatory guidelines regarding contraception while taking these medications.
See Pregnancy Testing paragraph in Section 5.3.1.1 for pregnancy testing instructions.

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Appendix E.
Joint Assessment
Joint counts will be performed by assessor(s) who must be well trained and part of the site 
personnel.  Whenever possible, the same evaluator should perform these assessments at 
all visits.
Number of Tender Joints:
The 68 joints assessed for tenderness include the 2 temporomandibular, 2 sternoclavicular, 
2 acromioclavicular joints, 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal, 
10 proximal interphalangeal, 8 distal interphalangeal joints of the hands, the 2 hips, 
2 knees, 2 ankles 2 mid-tarsal, 10 metatarsophalangeal, and 10 proximal interphalangeal 
joints of the feet. 
Joints are to be scored as either tender (1) or not tender (0), replaced (9) or not assessed 
(99).
Number of Swollen Joints:
The 66 joints to be examined for swelling are the same as those examined for tenderness, 
however excluding both hip joints.
Joints are to be scored as either swollen (1) or not swollen (0), replaced (9) or not assessed 
(99).
Synovial fluid and/or soft tissue swelling but not bony overgrowth represents a positive 
result for swollen joint count. 
Data will be recorded for tender and swollen joints (right or left side), i.e., a box (no, yes 
or not applicable) needs to be ticked for all joints.  The total number of tender and swollen 
joints (right and left) will be automatically calculated in the eCRF.

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Left
Right
Joint
Tender
Swollen
Tender
Swollen
Temporomandibular 
Acromioclavicular
Sternoclavicular
Shoulder#
Elbow#
Wrist#
MCP1#
MCP2#
MCP3#
MCP4#
MCP5#
IP of the thumb#
PIP of fingers 2#
PIP of fingers 3#
PIP of fingers 4#
PIP of fingers 5#
DIP of fingers 2
DIP of fingers 3
DIP of fingers 4
DIP of fingers 5
Hip*
Knee#
Ankle
Mid-Tarsal
MTP1
MTP2
MTP3
MTP4
MTP5
IP of great toe
PIP of toes 2

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Left
Right
Joint
Tender
Swollen
Tender
Swollen
PIP of toes 3
PIP of toes 4
PIP of toes 5
*
Hip will only be assessed for TJC (Tender Joint Counts), not for SJC (Swollen Joint Count).
#
Joints which will also count for DAS28-hsCRP evaluation.

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Appendix F.
PASI SCORE Definitions and Use 
The PASI score is an established measure of clinical efficacy for psoriasis medications.3
The PASI is a tool which provides a numeric scoring for patients overall psoriasis disease 
state, ranging from 0 to 72.  It is a linear combination of percent of surface area of skin 
that is affected and the severity of erythema, infiltration, and desquamation over four body 
regions.
The endpoints used are based on the percent reduction from baseline, generally 
summarized as a dichotomous outcome based on achieving over an X% reduction (or 
PASIX), where X is 50, 75, 90 and 100.
To calculate the PASI score, the four main body areas are assessed:  head (h), trunk (t), 
upper extremities (u) and lower extremities (l).  These correspond to 10, 30, 20 and 
40% of the total body area respectively.
The area of psoriatic involvement of these four areas (Ah, At, Au, and Al) is given a 
numerical value:  0 = no involvement, 1 = < 10%, 2 = 10 to < 30%, 3 = 30 to < 50%, 
4 = 50 to < 70%, 5 = 70 to < 90%, and 6 = 90 to 100% involvement.
The signs of severity, erythema (E), infiltration (I) and desquamation (D) of lesions 
are assessed using a numeric scale 0 – 4 where 0 is a complete lack of cutaneous 
involvement and 4 is the severest possible involvement; scores are made independently 
for each of the areas, h, t, u and l and represents a composite score for each area.  An 
illustration of judging erythema follows:  0 = no erythema, 1 = slight erythema, 
2 = moderate erythema, 3 = striking erythema, and 4 = exceptionally striking erythema.
The PASI score is calculated according to the following formula:
PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al

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Appendix G.
Static Physician Global Assessment (sPGA)
This sPGA is a 5 point score ranging from 0 to 4, based on the physician's assessment of 
the average thickness, erythema, and scaling of all psoriatic lesions (Table 3).32
The assessment is considered "static" which refers to the patients disease state at the time 
of the assessments, without comparison to any of the patient's previous disease states, 
whether at Baseline or at a previous visit.
A lower score indicates less body coverage, with 0 being clear and 1 being almost clear.
The investigator (or qualified site personnel) scores the erythema, induration and scaling 
of all psoriatic lesions from 0 – 4 based on the following descriptors:
Erythema
0
Normal (post-inflammatory hyper/hypopigmentation may be present)
1
Faint, diffuse pink or slight red coloration
2
Mild (light red coloration)
3
Definite red coloration (Dull to bright red)
4
Bright to Deep red coloration of lesions
Induration (Plaque Elevation)
0
None
1
Just detectable (possible slight elevation above normal skin)
2
Mild thickening (slight but definite elevation, typically edges are indistinct or 
sloped)
3
Clearly distinguishable to moderate thickening (marked definite elevation 
with rough or sloped edges)
4
Severe thickening with hard edges (marked elevation typically with hard or 
sharp edges)

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Scaling
0
No scaling
1
Minimal focal scaling (surface dryness with some desquamation)
2
Predominately fine scaling (fine scale partially or mostly covering lesions)
3
Moderate scaling (coarser scale covering most or all of the lesions)
4
Severe/coarse scaling covering almost all or all lesions (coarse, non-
tenacious scale predominates)
Scoring
A composite score is generated from the above data and the final sPGA is determined 
from this composite score as follows:
Clear
0 = 0 for all three
Almost clear
1 = mean > 0, < 1.5
Mild
2 = mean ≥ 1.5, < 2.5
Moderate
3 = mean ≥ 2.5, < 3.5
Severe
4 = mean ≥ 3.5

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Table 3.
sPGA Rating Scale for Overall Psoriatic Disease
Score
Short Description
Detailed Description
0
clear
No signs of psoriasis.
Post-inflammatory hyperpigmentation may be present.
1
almost clear
Normal to pink coloration.
Just detectable (possible slight elevation above normal skin).
No to minimal focal scaling.
2
mild
Pink to light red coloration.
Mild thickening (slight but definite elevation, typically edges are 
indistinct or sloped).
Predominantly fine scaling.
3
moderate
Dull to bright red coloration.
Clearly distinguishable to moderate thickening.
Moderate scaling.
4
severe
Bright to deep dark red coloration.
Severe thickening with hard edges.
Severe coarse scaling covering almost all or all lesions.

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Appendix H.
Leeds Dactylitis Index (LDI)
The LDI basic measures the ratio of the circumference of the affected digit to the 
circumference of the digit on the opposite hand or foot, using a minimum difference of 
10% to define a dactylitic digit.30  The ratio of circumference is multiplied by a tenderness 
score, using a modification of LDI which is a binary score (1 for tender, 0 for non-tender).  
If both sides are considered involved, or the circumference of the contralateral digit 
cannot be obtained, the number will be compared to data provided in the standard 
reference tables (Table 4 and Table 5).  This modification is referred to as LDI basic and 
will be applied in this study.  The LDI requires a finger circumference gauge or a tape 
measure to measure digital circumference. 
Dactylitis Count
The dactylitis count is the number of fingers and toes with dactylitis, with a range of 0 –
20.
Presence of Dactylitis
If dactylitis is present with any finger or toe, the subject is counted as a subject with 
dactylitis.
Table 4.
Hands (in cm)
Digit
Men
Women
Thumb
7.0
5.8
Index
6.3
5.4
Middle
6.3
5.4
Ring
5.9
5.0
Little
5.2
4.4

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Table 5.
Feet (in cm)
Digit
Men
Women
Central toe
8.2
7.2
Second
5.2
4.6
Middle
5.0
4.4
Fourth
5.0
4.4
Little
5.2
4.5

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Appendix I.
Leeds Enthesitis Index (LEI)
LEI is a validated enthesitis index that uses 6 sites for evaluation of enthesitis:  lateral 
epicondyle humerus left and right, Achilles tendon insertion left and right and medial 
condyle femur left and right.  The LEI demonstrated substantial to excellent agreement 
with other scores in the indication of psoriatic arthritis.26
Enthesitis Count
Tenderness on examination is recorded as either present (1) or absent (0) for each of the 
6 sites, for an overall score range of 0 – 6.
Presence of Enthesitis
If enthesitis is present with any of the 6 sites (lateral epicondyle humerus left and right, 
Achilles tendon insertion left and right and medial condyle femur left and right), the 
subject is counted as a subject with enthesitis.

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Appendix J.
Spondyloarthritis Research Consortium of Canada (SPARCC) 
Enthesitis Index
Enthesial sites examined include medial epicondyle (left and right), lateral epicondyle 
(left and right), supraspinatus insertion into greater tuberosity of humerus (left and right), 
greater trochanter (left and right), quadriceps insertion into superior border of patella (left 
and right), patellar ligament insertion into inferior pole of patella or tibial tubercle (left 
and right), Achilles tendon insertion into calcaneum (left and right), plantar fascia 
insertion into calcaneum (left and right).29
Enthesitis Count
Tenderness on examination is recorded as either present (1) or absent (0) for each of the 
16 sites, for an overall score range of 0 – 16.

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Appendix K.
mNAPSI – Modified Nail Psoriasis Severity Index
Modified NAPSI Instructions31
This tool will ask you to assess each abnormality for each of a subject's fingernails.  If you 
question which grade to give, your answer should be the lower of the grades.  
Three features or groups of features (pitting, onycholysis and oil-drop dyschromia, and 
crumbling) of each fingernail will be graded on a scale from 0 to 3, according to the 
directions below.  Four features (leukonychia, splinter hemorrhages, hyperkeratosis, and 
red spots in the lunula) will be graded as either present or absent for each fingernail.  
After you have viewed all the fingernails of a subject, consider all aspects of all of the 
subject's fingernails and place a mark on the visual analog scale giving a global 
assessment of their fingernails.
1.
Onycholysis:  Separation of the nail plate from the nail bed.  The separated part of 
the nail is opaque and can have white, yellow, or greenish tinge.  If there is a piece 
of nail missing, estimate where the nail normally would have ended at the end of 
the nail bed, and count that missing part as involved in onycholysis.
Oil-drop (salmon patch) dyschromia:  Reddish-brown discoloration under the nail 
plate.
Onycholysis and oil-drop dyschromia are considered together.  When looking at 
the nail, combine the total percentage area of the nail that is affected by either and 
use that combined total to score the nail.
Score
Percent of Nail with Onycholysis or Oil-Drop Dyschromia Present
0
No onycholysis or oil drop dyschromia present
1
1 – 10% of the nail has onycholysis or oil-drop dyschromia
2
11 – 30% of the nail has onycholysis or oil-drop dyschromia
3
> 30% of the nail has onycholysis or oil-drop dyschromia
2.
Pitting:  Small, sharply defined depressions in the nail surface.  Pits are discrete 
abnormalities ("ice-pick-like").  If there is nail plate crumbling that is confluent 

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with pits, do not score for pits.  If the pits are separate from crumbling, they may be 
scored regardless of whether crumbling is present or not.
Score
Number of Pits
0
0
1
1 – 10
2
11 – 49
3
> 50
3.
Nail plate crumbling:  Crumbling or fragmentation of friable nail plate which may 
be associated with confluent pitting.  Crumbling involves alteration of the nail plate 
surface.  Horizontal ridging of the nail, "wave-like" appearance, and horizontal 
lines are all features of crumbling.
Score
Percent of Nail with Crumbling Present
0
No crumbling
1
1 – 25% of the nail has crumbling
2
26 – 50% of the nail has crumbling
3
> 50% of the nail has crumbling
The next 4 abnormalities are scored only by their presence or absence.  A score of 1 
indicates present and a score of zero indicates not present.
1.
Leukonychia:  White spots in the nail plate due to psoriasis in the mid matrix.  
Leukonychia are just color changes.  If it appears that there is depression or 
irregularity to the nail surface, this may be pitting or crumbling, not leukonychia.  
If the leukonychia is adjacent to, or confluent with crumbling or pits, it is counted 
as part of the crumbling or pitting and not as a separate abnormality.
2.
Splinter hemorrhages:  Small, longitudinal, linear, dark brown hemorrhage under 
the fingernail.
3.
Nail bed hyperkeratosis:  Thickened keratin in the nail bed.

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4.
Red spots in the lunula:  Small pink or red macules in the lunula.

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Appendix L.
ACR Response Criteria
ACR response criteria is scored as follows:2
ACR 20:
●
At least 20% improvement in SJC* compared to baseline AND
●
At least 20% improvement in TJC* compared to baseline AND
●
At least 20% improvement in at least 3 out of the following 5 variables 
ACR 50:
●
At least 50% improvement in SJC* compared to baseline AND
●
At least 50% improvement in TJC* compared to baseline AND
●
At least 50% improvement in at least 3 out of the following 5 variables
ACR 70:
●
At least 70% improvement in SJC* compared to baseline AND
●
At least 70% improvement in TJC* compared to baseline AND
●
At least 70% improvement in at least 3 out of the following 5 variables 
1.
Patient's Assessment of PsA Pain Intensity (VAS) (See Appendix R)
2.
Patient's Global Assessment of Disease (VAS) (See Appendix R)
3.
Physician's Global Assessment of Disease Activity (VAS) (See Appendix M)
4.
Patient's Assessment of Disability on HAQ (See Appendix R)
5.
Acute phase reactant (serum CRP) (serum hs-CRP)
*
SJC and TJC are evaluated according to the complete joint count (see Appendix E).

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Appendix M.
Physician's Global Assessment of Disease Activity (PhGA)
The physician's global assessment of disease activity will be performed using 100 mm 
VAS ranging from no disease activity to maximal disease activity, after the question 
"Considering all the ways the disease affects your patient, draw a line on the scale for how 
well his or her condition is today."  To enhance objectivity, the physician must not be
aware of the specific patient's global assessment of disease activity, when performing his 
own assessment on that subject.

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Appendix N.
Minimal Disease Activity
The proportion of subjects achieving minimal disease activity (MDA) will be analysed.  A 
patient is classified as achieving MDA when meeting at least 5 of the 7 following criteria 
are met:25
●
Tender joint count ≤ 1
●
Swollen joint count ≤ 1
●
PASI ≤ 1 or BSA ≤ 3%
●
Patient Assessment of Pain-VAS ≤ 15
●
Patient Global Assessment of Disease Activity VAS ≤ 20
●
HAQ-DI ≤ 0.5
●
Tender entheseal points ≤ 1

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Appendix O.
DAS28 – hsCRP
DAS28-hsCRP will be calculated taking the following variables into account:25
●
TJC (on 28 joints, see Appendix E)
●
SJC (on 28 joints, see Appendix E)
●
Patient's global assessment of the disease on VAS (0 – 100)
●
Serum hsCRP level (mg/L)
The formula used for DAS28 – hsCRP is:  DAS28=0.56*√(TJC) + 0.28*√(SJC) + 0.36 
*Ln(hsCRP+1) + 0.014*VAS + 0.96

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Appendix P.
EULAR Response Criteria
The EULAR response criteria can be defined using the table below:35
Improvement in DAS28 from Baseline:
DAS28 at Endpoint
> 1.2
> 0.6 and ≤ 1.2
≤ 0.6
≤ 3.2
Good
> 3.2 and ≤ 5.1
Moderate
> 5.1
None

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Appendix Q.
PsARC Response
A subject is defined as a PsARC responder if, and only if, they have an improvement in 
two of the following four factors (with at least one factor being a joint count) and no 
worsening in the remaining factors:6
●
Patient global assessment of disease activity (0 – 100 mm VAS scale, 
improvement defined as decrease of ≥ 20 mm) 
●
Physician global assessment of disease activity (0 – 100 mm VAS scale, 
improvement defined as decrease ≥ 20 mm)
●
Tender 68-joint count (improvement defined as decrease of ≥ 30%)
●
Swollen 66-joint count (improvement defined as decrease of ≥ 30%)

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Appendix R.
Patient Reported Outcomes
Patient's Assessment of PsA Pain Intensity
The pain-VAS will be self-administered by the patient at visits indicated in the 
Appendix C.
The patient's assessment of PsA pain intensity will be performed using a horizontal 
100 mm visual analog scale (VAS), ranging from 0 (no pain) to 100 (severe pain) after the 
question:
"Please indicate with a vertical mark ( | ) through the horizontal line the most pain you had 
from your psoriatic arthritis today."
Patient's Global Assessment of Disease Activity
The patient global assessment VAS will be self-administered by the patient at visits 
indicated in Appendix C.
The patient's global assessment of disease activity will be performed using a horizontal 
100 mm VAS, ranging from 0 (very well) to 100 (very poor) after the question:
"Considering all the ways psoriatic arthritis affects you, please indicate with a vertical 
mark ( | ) through the horizontal line how well you are doing today."
Health Assessment Questionnaire Disability Index (HAQ-DI)
The HAQ-DI is a twenty-item patient reported outcome instrument that assesses current 
physical function/disability.  The HAQ-DI covers eight categories (dressing and 
grooming, hygiene, arising, reach, eating, grip, walking and common daily activities).  
There are four response options, ranging from 0 (no difficulty) to 3 (unable to do).  
HAQ-DI score is reported as a mean score between 0 and 3 by dividing the total score by 
the number of items answered.28

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The HAQ-DI has been the most-widely used instrument to assess physical function 
clinical trials of treatments for rheumatoid and psoriatic arthritis and has extensive 
evidence of its validity and other psychometric properties in this context.28
The HAQ-DI will be self-administered by the patient at visits indicated in Appendix C.
Medical Outcome Short Form Health Survey (SF-36) Version 2 (Acute Form)1,4
The SF-36 is a widely used and extensively studied instrument to measure health-related 
quality of life among healthy subjects and patients with acute and chronic conditions.  It 
consists of eight subscales that can be scored individually:  Physical Functioning, Role-
Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and 
Mental Health.4  Two overall summary scores, the Physical Component Summary (PCS) 
and the Mental Component Summary (MCS) also can be computed.1  The SF-36 has 
proven useful in monitoring general and specific populations, comparing the relative 
burden of different disease, differentiating the health benefits produced by different 
treatments, and in screening individual subjects.
The purpose of the SF-36 in this study is to assess the Health Related Quality of Life 
(HRQoL) of subjects.  Given the acute nature of this disease, version 2, with a 1-week 
recall period, will be used in this study.
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)7,8,34
The FACIT-F is a 13-item questionnaire that assesses self-reported fatigue and its impact 
upon daily activities and function.
The purpose of FACIT-F in this study is to assess the impact of fatigue on subjects with 
PsA.
Number of items:  13 items.

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Response options/scale:  Answers are based on a 5-point Likert scale.  Responses of "not 
at all," "a little," "somewhat," "quite a bit," and "very much" are available for each 
question, and correspond to scores of 0, 1, 2, 3, and 4, respectively.
Recall period for items:  7 days.
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)33
Each question is answered on a 0 to 10 scale.  For Questions 1 – 5, 0 means none and 
10 means very severe; for Question 6, 0 means 0 hours and 10 means 2 or more hours.  
All questions refer to last week.
1.
How would you describe the overall level of fatigue/tiredness you have 
experienced?
2.
How would you describe the overall level of AS neck, back or hip pain you have 
had?
3.
How would you describe the overall level of pain/swelling in joints other than 
neck, back or hips you have had? 
4.
How would you describe the overall level of discomfort you have had from any 
areas tender to touch or pressure? 
5.
How would you describe the overall level of morning stiffness you have had from 
the time you wake up?
6.
How long does your morning stiffness last from the time you wake up?
Calculation of BASDAI:  compute the mean of Questions 5 and 6.  Calculate the sum of 
the values of Questions 1 – 4 and add the result to the mean of Questions 5 and 6.  Divide 
the result by 5.

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Appendix S.
Rheumatology Common Toxicity Criteria v.2.0 Example
For designation of adverse event terms not shown in the Rheumatology Common Toxicity 
Criteria v.2.011 table, the approach described in Row 1 should be used.

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Rheumatology Common Toxicity Criteria v.2.0
Standardizing Assessment and Reporting of Adverse Effects in Rheumatology Clinical Trials:  Enabling Description of Comparative Safety Profiles for 
Antirheumatic Therapies
1 – Mild
Asymptomatic, or transient
Short duration (< 1 week)
No change in life style
No medication or OTC
2 – Moderate
Symptomatic
Duration (1 – 2 weeks)
Alter lifestyle occasionally meds 
relieve.  (May be prescription),
Study drug continued
3 – Severe
Prolonged symptoms, 
reversible, major functional 
impairment
Prescription meds/partial relief
May be hospitalized < 24 hr
Temporary study drug 
discontinuation, or/and dose 
reduced
4 – Includes Life-Threatening
At risk of death
Substantial disability, especially 
if permanent.
Multiple meds
Hospitalised > 24 hr
Study drug discontinued
A.  Allergic/Immunologic
A1.  Allergic 
reaction/hypersensitivity 
(includes drug fever)
Transient rash:  drug fever 
< 38°C:  transient, 
asymptomatic bronchospasm
Generalised urticaria responsive 
to meds; or drug fever > 38°C, 
or reversible bronchospasm
Symptomatic bronchospasm 
requiring meds; symptomatic 
urticaria persisting with meds, 
allergy related 
oedema/angioedema
Anaphylaxis, 
laryngeal/pharyngeal oedema, 
requiring resuscitation
A2.  Autoimmune reaction
Seriologic or other evidence of 
autoimmune reaction, but 
patient asymptomatic:  all 
organ function normal and no 
treatment is required 
(e.g., vitiligo)
Evidence of autoimmune 
reaction involving a 
non-essential organ or functions, 
requiring treatment other than 
immunosuppressive drugs 
(e.g., hypothyroidism)
Reversible autoimmune reaction 
involving function of a major 
organ or toxicity requiring short 
term immunosuppressive 
treatment (e.g., transient colitis 
or anaemia)
Causes major organ dysfunction, 
or progressive, not reversible, or 
requires long-term 
administration of high-dose 
immunosuppressive therapy
A3.  Rhinitis (includes sneezing, 
nasal stuffiness, post nasal 
discharge)
Transient, non-prescription 
meds relieve
Prescription med. required, slow
Corticosteroids or other 
prescription med. with 
persistent disabling symptoms 
such as impaired exercise 
tolerance
NA

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A.  Allergic/Immunologic (Continued)
A4.  Serum sickness
Transient, non-prescription 
meds relieve
Symptomatic, slow response to 
meds (e.g., oral corticosteroids)
Prolonged; symptoms only 
partially relieved by meds; 
parenteral corticosteroids 
required
Major organ dysfunction, 
requires long-term high-dose 
immunosuppressive therapy
A5.  Vasculitis
Localised, not requiring
treatment; or rapid response to 
meds; cutaneous
Symptomatic, slow response to 
meds (e.g., oral corticosteroids)
Generalised, parenteral 
corticosteroids required or/and 
short duration hospitalisation
Prolonged, hospitalisation, 
ischemic changes, amputation
B.  Cardiac
B1.  Arrhythmia
Transient, asymptomatic
Transient, but symptomatic or 
recurrent, responds to meds
Recurrent/persistent; 
maintenance prescription
Unstable, hospitalisation 
required, parenteral meds
B2.  Cardiac function decreased
Asymptomatic decline in 
resting ejection fraction by 
> 10%, but < 20% of baseline 
value
Asymptomatic decline of resting 
ejection fraction ≥ 20% of 
baseline value
CHF responsive to treatment
Severe or refractory CHF
B3.  Edema
Asymptomatic 
(e.g., 1 + feet/calves), 
self-limited, no therapy 
required
Symptomatic 
(e.g., 2 + feet/calves), requires 
therapy
Symptoms limiting function 
(e.g., 3 + feet/calves, 
2 + thighs), partial relief with 
treatment prolonged
Anasarca; no response to 
treatment
B4.  Hypertension (new onset or 
worsening)
Asymptomatic, transient 
increase by > 20 mmHg 
(diastolic) or to > 150/100 if 
previously normal, no therapy 
required
Recurrent or persistent increase 
> 150/100 or by > 10 mmHg 
(diastolic), requiring and 
responding readily to treatment
Symptomatic increase 
> 150/100, > 20 mmHg, 
persistent, requiring 
multi agency therapy, difficult 
to control
Hypertensive crisis
B5.  Hypotension (without 
underlying diagnosis)
Transient, intermittent, 
asymptomatic, orthostatic 
decrease in blood pressure 
> 20 mmHg
Symptomatic, without 
interference with function, 
recurrent or persistent 
> 20 mmHg decrease, responds 
to treatment
Syncope or symptomatic, 
interferes with function, 
requiring therapy and sustained 
medical attention, dose 
adjustment or drug 
discontinuation
Shock

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B.  Cardiac (Continued)
B6.  Myocardial ischaemia
Transient chest pain/ECG 
changes; rapid relief with nitro
Recurring chest pain, transient 
ECG ST-T changes; treatment 
relieves
Angina with infarction, no or 
minimal functional compromise, 
reduce dose or discontinue 
study drug
Acute myocardial infarction, 
arrthymia or/and CHF
B7.  Pericarditis/pericardial 
effusion
Rub heard, asymptomatic
Detectable effusion by 
echocardiogram, symptomatic 
NSAID required
Detectable on chest x-ray,
dyspnoea; or pericardiocentesis; 
requires corticosteroids
Pulsus alternates with low 
cardiac output; requires surgery
B8.  
Phlebitis/thrombosis/Embolism 
(excludes injection sites)
Asymptomatic, superficial, 
transient, local, or no treatment 
required
Symptomatic, recurrent, deep 
vein thrombosis, no 
anticoagulant therapy required
Deep vein thrombosis requiring 
anticoagulant therapy
Pulmonary embolism
C.  General (Constitutional)
C1.  Fatigue/malaise (asthenia)
Increase over baseline; most 
usual daily functions 
maintained, short term
Limits daily function 
intermittently over time
Interferes with basic ADL, 
persistent
Unable to care for self, bed or 
wheelchair bound > 50% of day 
debilitating, hospitalisation
C2.  Fever (pyrexia) (note:  
fever due to drug allergy should 
be coded as allergy)
Transient, few symptoms 
37.7 – 38.5°C
Symptomatic, recurrent 
38.6 – 39.9°C.  Relieved by 
meds
≥ 40°C; ≤ 24 h, persistent 
symptoms; partial response to 
meds
≥ 40°C, debilitating, > 24 h, 
hospitalisation; no relief with
meds
C3.  Headache
Transient or intermittent, no 
meds or relieved with OTC
Persistent, recurring, 
non-narcotic analgesics relieve
Prolonged with limited response 
to narcotic medicine
Intractable, debilitating, requires 
parenteral meds
C4.  Insomnia
Difficulty sleeping, short term, 
no interfering with function
Difficulty sleeping interfering 
with function, use of 
prescription med
Prolonged symptoms, with 
limited response to narcotic 
meds
Debilitating, hospitalisation; no 
relief with meds
C5.  Rigors, chills
Asymptomatic, transient, no 
meds, or non-narcotic meds 
relieve
Symptomatic, narcotic meds 
relieve
Prolonged symptoms, with 
limited response to narcotic 
meds
Debilitating, hospitalisation; no 
relief with meds
C6.  Sweating (diaphoresis)
Episodic, transient
Frequent, short term
Frequent, drenching, disabling
Dehydration, requiring IV 
fluids/hospitalization > 24 hrs

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C.  General (Constitutional) (Continued)
C7.  Weight gain
5% – 9.9%
10% – 19.9%
20% – 30%
NA
C8.  Weight loss
5% – 9.9%
10% – 19.9%
20% – 30%
NA
D.  Dermatologic
D1.  Alopecia
Subjective, transient
Objective, fully reversible
Patchy, wig used, partly 
reversible
Complete, or irreversible even if 
patchy
D2.  Bullous eruption
Localised, asymptomatic
Localised, symptomatic, 
requiring treatment
Generalised, responsive to 
treatment; reversible
Prolonged, generalised, or 
requiring hospitalisation for 
treatment
D3.  Dry skin
Asymptomatic, controlled with 
emollients
Symptoms eventually 
(1 – 2 wks) controlled with 
emollients
Generalised, interfering with 
ADL > 2 wks, persistent 
pruritis, partially responsive to 
treatment
Disabling for extended period, 
unresponsive to ancillary therapy 
and requiring study drug 
discontinuation for relief
D4.  Injection site reaction
Local erythema, pain, pruritis, 
< few days
Erythema, pain, oedema, may 
include superficial phlebitis,
1 – 2 wks
Prolonged induration, 
superficial ulceration; includes 
thrombosis
Major ulceration necrosis 
requiring surgery
D5.  Petechiae (without 
vasculitis)
Few, transient asymptomatic
Dependent areas, persistent up to 
2 wks
Generalised, responsive to 
treatment; reversible
Prolonged, irreversible, disabling
D6.  Photosensitivity
Transient erythema
Painful erythema and oedema 
requiring topical treatment
Blistering or desquamation, 
requires systematic 
corticosteroids
Generalised exfoliation or 
hospitalisation
D7.  Pruritis
Localised, asymptomatic, 
transient, local treatment
Intense, or generalised, relieved 
by systematic medication
Intense or generalised; poorly 
controlled despite treatment
Disabling, irreversible
D8.  Rash (not bullous)
Erythema, scattered 
macular/popular eruption; 
pruritis transient; TOC or no 
meds
Diffuse macular/popular 
eruption or erythema with 
pruritus; dry desquamation; 
treatment required
Generalised, moist 
desquamation, requires systemic 
corticosteroids; responsive to 
treatment; reversible
Exfoliative or ulcerating; or 
requires hospitalisation; or 
parenteral corticosteroids

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D.  Dermatologic (Continued)
D9.  
Induration/fibrosis/Thickening 
(not sclerodermal)
Localized, high density on 
palpation, reversible, no effect 
on ADL and not disfiguring
Local areas < 50% body surface, 
not disfiguring, transient 
interference with ADL, 
reversible
Generalized, disfiguring, 
interferes with ADL, reversible
Disabling, irreversible, systemic 
symptoms
E.  Ear/Nose/Throat
E1.  Hearing loss
Transient, intermittent, no 
interference with function
Symptomatic, treatment 
required, reversible
Interferes with function; 
incomplete response to 
treatment
Irreversible deafness
E2.  Sense of smell
Slightly altered
Markedly altered
Complete loss, reversible
Complete loss, without recovery
E3.  Stomatitis
Asymptomatic
Painful, multiple, can eat
Interferes with nutrition, slowly 
reversible
Requires enteral support; 
residual dysfunction
E4. Taste disturbance 
(dysgeusia)
Transiently altered; metallic
Persistently altered; limited 
effect on eating
Disabling, effect on nutrition
NA
E5.  Tinnitus
Intermittent, transient, no 
interference with function
Requires treatment, reversible
Disabling, or associated with 
hearing loss
Irreversible deafness
E6.  Voice changes (includes 
hoarseness, loss of voice, 
laryngitis)
Intermittent hoarseness, able to 
vocalise
Persistent hoarseness, able to 
vocalise
Whispered speech, slow return 
of ability to vocalise
Unable to vocalize for extended
E7.  Xerostomia (dry mouth)
Transient dryness
Relief with meds
Interferes with nutrition, slowly 
reversible
Extended duration interference 
with nutrition, requires 
parenteral nutrition
F.  Eye/Ophthalmologic
F1.  Cataract
Asymptomatic, no change in 
vision, non-progressive
Symptomatic, partial visual loss, 
progressive
Symptoms impairing function, 
vision loss requiring treatment, 
including surgery
NA
F2.  Conjunctivitis
Asymptomatic, transient, rapid 
response to treatment
Symptomatic, responds to 
treatment, changes not 
interfering with function
Symptoms prolonged, partial 
response to treatment, interferes 
with function
NA

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F.  Eye/Ophthalmologic (Continued)
F3.  Lacrimation increased 
(tearing, watery eyes)
Symptoms not requiring 
treatment, transient
Symptomatic, treatment 
required, reversible
Unresponsive to treatment with 
major effect on function
NA
F4.  Retinopathy
Asymptomatic, 
non-progressive, no treatment
Reversible change in vision; 
readily responsive to treatment
Disabling change in vision 
ophthalmological findings 
reversible, sight improves over 
time
Loss of sight
F5.  Vision changes 
(e.g., blurred, photophobia, 
night blindness, vitreous 
floaters)
Asymptomatic, transient, no 
treatment required
Symptomatic, vision changes not 
interfering with function, 
reversible
Symptomatic, vision changes 
interfering with function
Loss of sight
F6.  Xerophtalmia (dry eyes)
Mild scratchiness
Symptomatic without interfering 
with function, requires artificial 
tears
Interferes with vision/function, 
corneal ulceration
Loss of sight
G.  Gastrointestinal
G1.  Anorexia
Adequate food intake, minimal 
weight loss
Symptoms requiring oral 
nutritional supplementation
Prolonged, requiring iv support
Requires hospitalization for 
nutritional support
G2.  Constipation
Asymptomatic, transient, 
responds to stool softener, OTC 
laxatives
Symptomatic, requiring 
prescription laxatives, reversible
Obstipation requiring medical 
intervention
Bowel obstruction.  Surgery 
required.
G3.  Diarrhea
Transient, increase of 
2 – 3 stools/day over 
pre-treatment (no blood or 
mucus), OTC agents relieve
Symptomatic, increase 
4 – 6 stools/day, nocturnal 
stools, cramping, requires 
treatment with prescription meds
Increase > 6 stools/day, 
associated with disabling 
symptoms, e.g., incontinence, 
severe cramping, partial 
response to treatment.
Prolonged, dehydration, 
unresponsive to treatment, 
requires hospitalization
G4.  Dyspepsia (heartburn)
Transient, intermittent, 
responds to OTC antacids, 
H-2 blockers
Prolonged, recurrent, requires 
prescription meds, relieved by 
meds
Persistent despite treatment, 
interferes with function, 
associated with GI bleeding
NA

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G.  Gastrointestinal (Continued)
G5.  GI bleed (gastritis, gastric 
or duodenal ulcer 
diagnosed-define aetiology)
Asymptomatic, endoscopic 
finding, haemocult + stools, no 
transfusion, responds rapidly to 
treatment
Symptomatic, transfusion 
≤2 units needed; responds to 
treatment
Haematemesis, transfusion 
3 – 4 units, prolonged 
interference with function
Recurrent, transfusion > 4 units, 
perforation, requiring surgery, 
hospitalisation
G6.  Haematochezia (rectal 
bleeding)
Haemorrhodial, asymptomatic, 
no transfusion
Symptomatic, transfusion 
≤2 units, reversible
Recurrent, transfusion 
> 3 – 4 units
> 4 units, hypotension, requiring 
hospitalization
G7.  Hepatitis
Laboratory abnormalities, 
asymptomatic, reversible
Symptomatic laboratory 
abnormalities, not interfering 
with function, slowly reversible
Laboratory abnormalities 
persistent > 2 wks, symptoms 
interfere with function
Progressive, hepato-renal, 
anasarca, pre-coma or coma
G8.  Nausea, or nausea/vomiting 
(use diagnostic term)
Transient, intermittent, minimal 
interference with intake, rapid 
response to meds
Persistent, recurrent, requires 
prescription meds, intake 
maintained
Prolonged, interferes with daily 
function and nutritional intake, 
periodic iv fluids
Hypotensive, hospitalization, 
parenteral nutrition, 
unresponsive to out-patient 
management
G9.  Pancreatitis
Amylase elevation, intermittent 
nausea/vomiting, transient, 
responds rapidly to treatment
Amylase elevation with 
abdominal pain, nausea, 
occasional vomiting, responsive 
to treatment
Severe, persistent abdominal 
pain with pancreatitic enzyme 
elevation, incomplete or slow 
response to treatment
Complicated by shock, 
haemorrhage (acute circulatory 
failure)
G10.  Proctitis
Perianal pruritus, haemorrhoids 
(new onset), transient, or 
intermittent, relieved by OTC 
meds
Tenesmus or ulcerations, anal 
fissure, responsive to treatment, 
minimal interference with 
function
Unresponsive to treatment, 
marked interference with 
function
Mucosal necrosis with 
haemorrhage, infection, surgery 
required.
H.  Musculoskeletal
H1.  Avascular necrosis
Asymptomatic MRI changes, 
non-progressive
MRI changes and symptoms 
responsive to rest and analgesia
MRI changes, symptoms 
requiring surgical intervention
Wheelchair bound; surgical 
repair not possible
H2.  Arthralgia
Intermittent transient 
symptoms, no meds or relieved 
by OTC meds
Persistent or recurrent 
symptoms, resolve with meds, 
little effect on function
Severe symptoms despite meds 
impairs function
Debilitating, hospitalisation 
required for treatment

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H.  Musculoskeletal (Continued)
H3.  Leg cramps
Transient, intermittent, does 
not interfere with function
Recurrent symptoms, minimally 
interferes with function or sleep, 
responds to meds
Persistent, prolonged 
interference with function or 
sleep, partial or no response to 
meds
NA
H4.  Myalgia
Occasional; does not interfere 
with function
Frequent, requires meds 
(non-narcotic); minor effects on 
function
Major change in 
function/lifestyle, narcotic pain 
meds
Debilitating, profound weakness, 
requires wheelchair, 
unresponsive to meds
I.  Neuropsychiatric
I1.  Anxiety or depression 
(mood alteration)
Symptomatic, does not 
interfere with function; no 
meds
Frequent symptoms, responds to 
meds; interferes with ADL at 
times
Persistent, prolonged symptoms, 
partial or no response to meds, 
limits daily function
Suicidal ideation or danger to 
self
I2.  Cerebrovascular ischaemia
NA
Single transient ischaemic event, 
responsive to treatment
Recurrent transient ischaemic 
events
Cerebrovascular vascular 
accident with permanent 
disability
I3.  Cognitive disturbance
Subjective symptoms, transient, 
intermittent, not interfering 
with function
Objective symptoms, persisting, 
interferes with daily function 
occasionally
Persistent, or worsening 
objective symptoms; interferes 
with routine daily routine
Debilitating/disabling and 
permanent; toxic psychosis
I4.  Depressed consciousness 
(somnolence)
Observed, transient, 
intermittent, not interfering 
with function
Somnolence or sedation, 
interfering with function
Persistent, progressive, 
obundation, stupor
Coma
I5.  Inability to concentrate
Subjective symptoms, does not 
interfere with function
Objective findings, interferes 
with function
Persistent, prolonged objective 
findings or organic cause
NA
I6.  Insomnia (in absence of 
pain)
Occasional difficulty sleeping, 
transient intermittent, not 
interfering with function
Recurrent difficulty sleeping; 
requires meds for relief; 
occasional interference with 
function
Persistent or worsening 
difficulty sleeping; severely 
interferes with routine daily 
function
NA
I7.  Libido decreased
Decrease in interest
Loss of interest; influences 
relationship
Persistent, prolonged interfering 
with relationship
NA

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I.  Neuropsychiatric (Continued)
I8.  Peripheral motor neuropathy
Subjective or transient loss of 
deep tendon reflexes; function 
maintained
Objective weakness, persistent, 
no significant impairment of 
daily function
Objective weakness with 
substantial impairment of 
function
Paralysis
I9.  Peripheral sensory 
neuropathy (sensory 
disturbance)
Subjective symptoms without 
objective findings, transient, 
not interfering with function
Objective sensory loss,
persistent, not interfering with 
function
Prolonged sensory loss or 
paraethesias interfering with 
function
NA
I10.  Seizure
NA
Recurrence of old seizures, 
controlled with adjustment of 
medication
Recurrence/exacerbation with 
partial response to medication
Recurrence not controlled, 
requiring hospitalization; new 
seizures
I11.  Vertigo (dizziness)
Subjective symptoms, transient, 
intermittent, no treatment
Objective findings, recurrent, 
meds relieve, occasionally 
interfering with function
Persistent, prolonged, 
interfering with daily function; 
partial response to medication
Debilitating without response to 
medication, hospitalization
J.  Pulmonary
J1.  Asthma
Occasional wheeze, no 
interference with activities
Wheezing, requires oral meds,
occasional interference with 
function
Debilitating, requires nasal O2
Requires ventilator assistance
J2.  Cough
Transient, intermittent, 
occasional OTC meds relieve
Persistent, requires narcotic or 
other prescription meds for relief
Recurrent, persistent coughing 
spasms without consistent relief 
by meds, interferes with 
function
Interferes with oxygenation; 
debilitating
J3.  Dyspnea
Subjective, transient, no 
interference with function
Symptomatic, intermittent or 
recurring, interferes with 
exertional activities
Symptomatic during daily 
routine activities, interferes with 
function, treatment with 
intermittent nasal O2 relieves
Symptomatic at rest, debilitating, 
requires constant nasal O2
J4.  Pleuritic pain (pleurisy)
Transient, intermittent 
symptoms, no treatment or 
OTC meds relieve
Persistent symptoms, requires 
prescription meds for relief
Prolonged symptoms, interferes 
with function, requires frequent 
narcotic pain relief
Debilitation, requiring 
hospitalisation

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J.  Pulmonary (Continued)
J5.  Pneumonitis (pulmonary 
infiltrates)
Asymptomatic radiographic 
changes, transient, no treatment 
required
Symptomatic, persistent, 
requiring corticosteroids
Symptomatic, requiring 
treatment including O2
Debilitating, not reversible; or 
requiring assisted ventilation
J6.  Pulmonary function 
decreased (FVC or carbon 
monoxide diffusion capacity –
DLCO)
76% – 90% of pre-treatment 
value
51% – 75% of pre-treatment 
value
26% – 50% of pre-treatment 
value
≤ 25% of pre-treatment value

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Appendix T.
Class VI and Class VII Topical Corticosteroid Examples
Class
Generic Name or Local Equivalent
%
VI
Prednicarbate
0.05
Triamcinolone acetonide
0.025
Desonide
0.05
Fluocinolone acetonide
0.01
Triamcinolone acetonide
0.025
Flumethasone pivalate
0.03
Fluocinolone acetonide
0.01
Desonide
0.05
Triamcinolone acetonide
0.025
Betamethasone valerate
0.01
VII
Betamethasone valerate
0.2
Hydrocortisone acetate
1.0
Hydrocortisone
1.0, 2.5
Methylprednisolone
0.25
Fluorometholone
0.025
Hydrocortisone
1.0, 2.5

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Appendix U.
Follow-up Phone Call 
Site Name/Number: _______/_____
Subject Number: ____________
Contact subjects that signed the protocol Amendment 1 ICF approximately 140 days 
(20 weeks) following last study drug administration.
Date of Call/Visit: ____________
□Lost to Follow-up (check this box if subject was not willing to provide any 
follow-up information or you were unable to speak to the subject following at least 
two phone call attempts and one certified letter).
□No Events Reported
At the Follow-up Phone Call: 
□Record any adverse events (AEs) and/or serious adverse events (SAEs) that 
occurred since the subject's last study visit.  Document all AEs/SAEs in source 
records and EDC system.  Report all SAEs to AbbVie within 24 hours of 
awareness of the event.  
□Request update to the status of any AE that was ongoing at the last study visit. 
□Request update to any concomitant medication(s) that was ongoing at the last 
study visit.  Record any change in concomitant medication in source documents 
and EDC. 
Name of person completing form (printed): ___________________________

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Signature of person completing form: ________________________________
Date: _______________
Please email this completed form to 

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Appendix V.
Protocol Amendment:  List of Changes
The summary of changes is listed in Section 1.1.
Specific Protocol Changes
Section 1.0  Title Page
"Sponsor Contact:" previously read:
Sponsor Contact:
Has been changed to read:
Sponsor Contact:
Section 1.0  Title Page
"Emergency Medical Contact:," "Bldg" previously read:
Bldg AP30
Has been changed to read:
Bldg AP31

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Section 1.1  Synopsis
Subsection Diagnosis and Main Criteria for Inclusion/Exclusion:
Heading "Main Inclusion:"
Criterion 2 previously read:
Women of childbearing potential who are sexually active, must agree to use at least 
one accepted method of contraception throughout the study, including 16 weeks after last 
dose of study drug is given.
Has been changed to read:
Women of childbearing potential who are sexually active, must agree to use at least 
one accepted method of contraception throughout the study, including 20 weeks after last 
dose of study drug is given.
Section 1.1  Synopsis
Subsection Diagnosis and Main Criteria for Inclusion/Exclusion:
Heading "Main Exclusion:"
Criterion 1 previously read:
Female subject who is pregnant, breastfeeding or is considering becoming pregnant 
during study participation, including 16 weeks after the last dose of study drug is given.
Has been changed to read:
Female subject who is pregnant, breastfeeding or is considering becoming pregnant 
during study participation, including 20 weeks after the last dose of study drug is given.
Section 1.2  List of Abbreviations and Definition of Terms
Subsection Abbreviations
Add:
t1/2
Half-life

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Section 3.3  Differences Statement
First sentence previously read:
Study M16-244 is a 52 week multicenter, single-arm, open-label extension (OLE), 
consisting of 36 weeks of study drug administration and 16 weeks follow-up, to 
Study 1311.5.
Has been changed to read:
Study M16-244 is a 52 week multicenter, single-arm, open-label extension (OLE), 
consisting of 36 weeks of study drug administration and 20 weeks follow-up, to 
Study 1311.5.
Section 5.1  Overall Study Design and Plan:  Description
Subsection Follow-Up Period
First paragraph previously read:
Subjects will have follow-up visits at Week 48 and 52.  All Follow-Up Visit procedures 
are noted in Appendix C.  Subjects who discontinue study drug treatment early will need 
to attend an early End of Treatment (EOT) visit ideally within 2 weeks after the decision 
and preferably prior to the administration of any new therapies.  An additional End of 
Study (EOS) visit, 16 weeks after their last dose of study drug, is required to determine 
the status of any ongoing AEs/SAEs or the occurrence of any new AEs/SAEs (see 
Appendix C and Section 5.4.1).
Has been changed to read:
Subjects will have follow-up visits at Week 48 and 52 and a Follow-up Phone call 
20 weeks after the last dose of study drug.  All Follow-up Visit procedures are noted in 
Appendix C.  Subjects who discontinue study drug treatment early will need to attend an 
early End of Treatment (EOT) visit ideally within 2 weeks after the decision and 
preferably prior to the administration of any new therapies.  An End of Study (EOS) visit 
16 weeks after the last dose of study drug and a Follow-up Phone Call 20 weeks after the 
last dose of study drug is required to determine the status of any ongoing AEs/SAEs or the 
occurrence of any new AEs/SAEs (see Appendix C and Section 5.4.1).

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Figure 2.  Study M16-244 Study Design
Previously read:
Has been changed to read:
Section 5.2.1  Inclusion Criteria
Criterion 2 previously read:
Women of childbearing potential must agree to use at least one of the following methods 
of contraception throughout the study including 16 weeks after the last study drug dose is 
given.

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Has been changed to read:
Women of childbearing potential must agree to use at least one of the following methods 
of contraception throughout the study including 20 weeks after the last study drug dose is 
given.
Section 5.2.2  Exclusion Criteria
Criterion 1 previously read:
Female subject who is pregnant, breastfeeding or is considering becoming pregnant 
during study participation, including 16 weeks after the last dose of study drug is given.
Has been changed to read:
Female subject who is pregnant, breastfeeding or is considering becoming pregnant 
during study participation, including 20 weeks after the last dose of study drug is given.
Section 5.2.4  Contraception Recommendations and Pregnancy
First paragraph, last sentence previously read:
The method chosen must be practiced throughout the study including 16 weeks after the 
last dose of study drug is given.
Has been changed to read:
The method chosen must be practiced throughout the study including 20 weeks after the 
last dose of study drug is given.
Section 5.4.1  Discontinuation of Individual Subjects
First bullet previously read:
A subject does not attain a protocol defined (defined as an improvement in tender and
swollen joint count of ≥ 20% compared with the baseline in Study 1311.5) at 2 
consecutive visits at Week 12 visit, or thereafter.

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Has been changed to read:
A subject does not attain a protocol defined response (defined as an improvement in 
tender and swollen joint count of ≥ 20% compared with the baseline in Study 1311.5) at 2 
consecutive visits at Week 12 visit, or thereafter.
Section 5.4.1  Discontinuation of Individual Subjects
Third paragraph, last sentence previously read:
For subjects that prematurely discontinue, study drug will not be given at the early EOT 
visit and subjects should attend their EOS Visit 16 weeks after last study drug dose to 
determine the status of any ongoing AEs/SAEs or the occurrence of any new AEs/SAEs 
(see Appendix C).
Has been changed to read:
For subjects that prematurely discontinue, study drug will not be given at the early EOT 
visit and subjects should attend their EOS Visit 16 weeks after last study drug dose and 
complete a Follow-up Phone Call 20 weeks after the last dose of study drug to determine 
the status of any ongoing AEs/SAEs or the occurrence of any new AEs/SAEs (see 
Appendix C).
Section 6.1.4  Adverse Event Collection Period
First paragraph, first sentence previously read:
All adverse events reported from the time of study drug administration until 16 weeks, 
following discontinuation of study drug administration have elapsed will be collected, 
whether solicited or spontaneously reported by the subject.
Has been changed to read:
All adverse events reported from the time of study drug administration until 20 weeks, 
following discontinuation of study drug administration have elapsed will be collected, 
whether solicited or spontaneously reported by the subject.

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Figure 3.  Adverse Event Collection
Previously read:
Has been changed to read:
Section 6.1.5  Adverse Event Reporting
"Primary Therapeutic Area Medical Director:," "Bldg" previously read:
Bldg AP30
Has been changed to read:
Bldg AP31

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Section 7.0  Protocol Deviations
"Alternate Contact:" previously read:
Has been changed to read:
Section 8.1.6.2.1  Treatment-Emergent Adverse Events
First paragraph, last sentence previously read:
AEs starting more than 105 days following the last dose of study drug will not be included 
in summaries of TEAEs

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Has been changed to read:
AEs starting more than 140 days following the last dose of study drug will not be included 
in summaries of TEAEs.
Section 13.0  Completion of the Study
Fourth paragraph previously read:
The end-of-study is defined as the date of the last subject's last visit, 16 weeks after the 
final dose of study drug, see Appendix C.
Has been changed to read:
The EOS is defined as the date of the last subject's last scheduled visit or the date of the 
Follow-up Phone Call, whichever is later, see Appendix C.
Appendix B.  List of Protocol Signatories
Previously read:
Name
Title
Functional Area
Clinical
Clinical
Statistics
Pharmacokinetics
BioAnalytics
Clinical 
Has been changed to read:
Name
Title
Functional Area
Clinical
Clinical
Statistics
Pharmacokinetics
Clinical 
Medical Writing

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Appendix C.  Study Activities
Previously read:
Treatment
Follow-Up
V1
V2
V3
V4
V5 (EOT/Early 
EOTs)
V6
EOS 
(EOT/Early 
EOT + 
16 Weeks)
Week
0a
4t
12
24
36
48
52
Day
1
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
Informed Consentb
X
Inclusion/exclusion criteria
X
Medical/Surgical Historyc
Xa
Patient's Global Assessment of Disease 
Activity (VAS) (PtGA)d
Xa
X
X
X
X
X
X
Patient's Assessment of PsA Pain 
Intensity (VAS)d
Xa
X
X
X
X
X
X
HAQ-DId
Xa
X
X
X
X
X
X
BASDAId,m
Xa
X
X
X
X
SF-36v2d
Xa
X
X
X
X
X
X
FACIT-Fd
Xa
X
X
X
Vital Signse
Xa
X
X
X
X
X
X
ECGe
Xa
X
X
X
Physical Exame
(c = complete, t = targeted)
X-ca
X-t
X-t
X-t
X-t
X-t
X-c

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Treatment
Follow-Up
V1
V2
V3
V4
V5 (EOT/Early 
EOTs)
V6
EOS 
(EOT/Early 
EOT + 
16 Weeks)
Week
0a
4t
12
24
36
48
52
Day
1
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
Concomitant Therapyf
Xa
X
X
X
X
X
X
Adverse Event Assessmentg
Xa
X
X
X
X
X
X
Tender Joint Count (TJC 68)h
Xa
X
X
X
X
X
X
Swollen Joint Count (SJC 66)h
Xa
X
X
X
X
X
X
PASIh,u
Xa
X
X
X
X
X
X
BSAh
Xa
X
X
X
X
X
X
Static Physician's Global Assessment for 
Psoriasis (sPGA)h,u
Xa
X
X
X
X
X
X
Physician's Global Assessment of Disease 
Activity (PhGA) (VAS)h
Xa
X
X
X
X
X
X
Leeds Dactylitis Index (LDI)h
Xa
X
X
X
X
X
Leeds Enthesitis Index (LEI)h
Xa
X
X
X
X
X
SPARCCh
Xa
X
X
X
X
X
mNAPSIh
Xa
X
X
X
X
X
mTSS (X-ray)i
X
X
Pregnancy Testj
Xa
X
X
X
X
X
X

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Treatment
Follow-Up
V1
V2
V3
V4
V5 (EOT/Early 
EOTs)
V6
EOS 
(EOT/Early 
EOT + 
16 Weeks)
Week
0a
4t
12
24
36
48
52
Day
1
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
Safety Labs (Chemistry, Hematology, 
Urinalysis)k,v
Xa
X
X
X
X
X
X
hsCRP for DASk
Xa
X
X
X
X
X
X
Blood Sample for PKk,l
Xa
X
X
X
X
X
X
Blood Sample for ADA Assayk,l
Xa
X
X
X
X
X
X
TB screeningk,n
X
Xr
Local tolerabilityo
X
X
X
X
X
Study drug administration
X
Xp
(additional)
X
X
X
Monitoring for hypersensitivity reactionq
X
X
X
X
X
Conclusion of Subject participation
X

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Has been changed to read:
Treatment
Follow-Up
V1
V2
V3
V4
V5 
(EOT/Early 
EOTs)
V6
EOS (EOT/Early 
EOT + 16 Weeks)
Follow-up 
Phone Call
Week
0a
4t
12
24
36
48
52
56
Day
1
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
392 ± 4
Informed Consentb
X
Inclusion/exclusion criteria
X
Medical/Surgical Historyc
Xa
Patient's Global Assessment of 
Disease Activity (VAS) (PtGA)d
Xa
X
X
X
X
X
X
Patient's Assessment of PsA Pain 
Intensity (VAS)d
Xa
X
X
X
X
X
X
HAQ-DId
Xa
X
X
X
X
X
X
BASDAId,m
Xa
X
X
X
X
SF-36v2d
Xa
X
X
X
X
X
X
FACIT-Fd
Xa
X
X
X
Vital Signse
Xa
X
X
X
X
X
X
ECGe
Xa
X
X
X
Physical Exame
(c = complete, t = targeted)
X-ca
X-t
X-t
X-t
X-t
X-t
X-c
Concomitant Therapyf
Xa
X
X
X
X
X
X
X

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Treatment
Follow-Up
V1
V2
V3
V4
V5 
(EOT/Early 
EOTs)
V6
EOS (EOT/Early 
EOT + 16 Weeks)
Follow-up 
Phone Call
Week
0a
4t
12
24
36
48
52
56
Day
1
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
392 ± 4
Adverse Event Assessmentg
Xa
X
X
X
X
X
X
X
Tender Joint Count (TJC 68)h
Xa
X
X
X
X
X
X
Swollen Joint Count (SJC 66)h
Xa
X
X
X
X
X
X
PASIh,u
Xa
X
X
X
X
X
X
BSAh
Xa
X
X
X
X
X
X
Static Physician's Global 
Assessment for Psoriasis 
(sPGA)h,u
Xa
X
X
X
X
X
X
Physician's Global Assessment of 
Disease Activity (PhGA) (VAS)h
Xa
X
X
X
X
X
X
Leeds Dactylitis Index (LDI)h
Xa
X
X
X
X
X
Leeds Enthesitis Index (LEI)h
Xa
X
X
X
X
X
SPARCCh
Xa
X
X
X
X
X
mNAPSIh
Xa
X
X
X
X
X
mTSS (X-ray)i
X
X
Pregnancy Testj
Xa
X
X
X
X
X
X
Safety Labs (Chemistry, 
Hematology, Urinalysis)k,v
Xa
X
X
X
X
X
X

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Treatment
Follow-Up
V1
V2
V3
V4
V5 
(EOT/Early 
EOTs)
V6
EOS (EOT/Early 
EOT + 16 Weeks)
Follow-up 
Phone Call
Week
0a
4t
12
24
36
48
52
56
Day
1
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
392 ± 4
hsCRP for DASk
Xa
X
X
X
X
X
X
Blood Sample for PKk,l
Xa
X
X
X
X
X
X
Blood Sample for ADA Assayk,l
Xa
X
X
X
X
X
X
TB screeningk,n
X
Xr
Local tolerabilityo
X
X
X
X
X
Study drug administration
X
Xp
(additional)
X
X
X
Monitoring for hypersensitivity 
reactionq
X
X
X
X
X
Conclusion of Subject 
participation
X

Risankizumab/ABBV-066
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EudraCT 2016-003113-94
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Appendix D.  Local Requirements
Subsection Local Requirements – Japan
Heading "Section 7.0:  Protocol Deviations"
"Alternate Contact:" previously read:
Has been changed to read:

Risankizumab/ABBV-066
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Appendix D.  Local Requirements
Subsection Local Requirements – Japan
Heading "Appendix C:  Study Activities Table"
Table previously read:
Treatment
Follow-Up
V1
V2
V3
V4
V5 
(EOT/Early 
EOT)
V6
EOS 
(EOT/Early 
EOT + 
16 Weeks)
Week
0
4
12
24
36
48
52
Day
1 ± 4
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
HBV DNA*
X
X
X
Has been changed to read:
Treatment
Follow-Up
V1
V2
V3
V4
V5 
(EOT/Early 
EOT)
V6
EOS 
(EOT/Early 
EOT + 
16 Weeks)
Follow-up 
Phone 
Call
Week
0
4
12
24
36
48
52
56
Day
1 ± 4
29 ± 4
85 ± 4
169 ± 4
253 ± 4
336 ± 4
365 ± 4
365 ± 4
HBV 
DNA*
X
X
X
Appendix J.  Spondyloarthritis Research Consortium of Canada (SPARCC) 
Enthesitis Index
Subsection Enthesitis Count
Previously read:
Tenderness on examination is recorded as either present (1) or absent (0) for each of the 
18 sites, for an overall score range of 0 – 16.
Has been changed to read:
Tenderness on examination is recorded as either present (1) or absent (0) for each of the 
16 sites, for an overall score range of 0 – 16.

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Appendix U.  Follow-up Phone Call
Add:  new appendix title and text
Appendix U.
Follow-up Phone Call
Site Name/Number: _______/_____
Subject Number: ____________
Contact subjects that signed the protocol Amendment 1 ICF approximately 140 days 
(20 weeks) following last study drug administration.
Date of Call/Visit: ____________
□Lost to Follow-up (check this box if subject was not willing to provide any 
follow-up information or you were unable to speak to the subject following at least 
two phone call attempts and one certified letter).
□No Events Reported
At the Follow-up Phone Call: 
□Record any adverse events (AEs) and/or serious adverse events (SAEs) that 
occurred since the subject's last study visit.  Document all AEs/SAEs in source 
records and EDC system.  Report all SAEs to AbbVie within 24 hours of 
awareness of the event.  
□Request update to the status of any AE that was ongoing at the last study visit. 
□Request update to any concomitant medication(s) that was ongoing at the last 
study visit.  Record any change in concomitant medication in source documents 
and EDC. 

Risankizumab/ABBV-066
M16-244 Protocol Amendment 1
EudraCT 2016-003113-94
159
Name of person completing form (printed): ___________________________
Signature of person completing form: ________________________________
Date: _______________
Please email this completed form to