A Phase 2, Multicenter, Double-Blind, Parallel Group Long Term Extension Study in Rheumatoid Arthritis Subjects Who Have Completed a Preceding Phase 2 Randomized Controlled Trial With ABBV-105 Given Alone or in Combination With Upadacitinib (ABBV-599)
Phase: PHASE2
Conditions: Rheumatoid Arthritis (RA)
Sponsor: AbbVie

NCT03823378

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TABLE OF CONTENTS
1
SYNOPSIS
5
2
INTRODUCTION
8
2.1
BACKGROUND AND RATIONALE
8
2.2
BENEFITS AND RISKS TO SUBJECTS
8
3
STUDY OBJECTIVES AND ENDPOINTS
10
3.1
OBJECTIVES
10
3.2
EFFICACY ENDPOINTS
10
3.3
SAFETY ENDPOINTS
11
3.4
BIOMARKER RESEARCH
12
4
INVESTIGATIONAL PLAN
12
4.1
OVERALL STUDY DESIGN AND PLAN
12
4.2
DISCUSSION OF STUDY DESIGN
13
5
STUDY ACTIVITIES
14
5.1
ELIGIBILITY CRITERIA
14
5.2
CONTRACEPTION RECOMMENDATIONS
17
5.3
PROHIBITED MEDICATIONS AND THERAPY
18
5.4
PRIOR AND CONCOMITANT THERAPY
20
5.5
WITHDRAWAL OF SUBJECTS AND DISCONTINUATION OF STUDY
21
5.6
FOLLOW-UP FOR SUBJECT WITHDRAWAL FROM STUDY
23
5.7
STUDY DRUG
24
5.8
RANDOMIZATION/DRUG ASSIGNMENT
25
5.9
PROTOCOL DEVIATIONS
25
6
SAFETY CONSIDERATIONS
26
6.1
COMPLAINTS AND ADVERSE EVENTS
26
6.2
TOXICITY MANAGEMENT
30
7
STATISTICAL METHODS & DETERMINATION OF SAMPLE SIZE
31
7.1
STATISTICAL AND ANALYTICAL PLANS
31

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7.2
DEFINITION FOR ANALYSIS POPULATIONS
31
7.3
STATISTICAL ANALYSES FOR EFFICACY
31
7.4
STATISTICAL ANALYSES FOR SAFETY
32
7.5
INTERIM ANALYSIS
32
8
ETHICS
33
8.1
INDEPENDENT ETHICS COMMITTEE/INSTITUTIONAL REVIEW BOARD
33
8.2
ETHICAL CONDUCT OF THE STUDY
33
8.3
SUBJECT CONFIDENTIALITY
33
9
SOURCE DOCUMENTS AND CASE REPORT FORM COMPLETION
33
10 DATA QUALITY ASSURANCE
33
11 COMPLETION OF THE STUDY
34
LIST OF TABLES
TABLE 1.
EXAMPLES OF COMMONLY USED STRONG CYP3A OR CYP1A2 INHIBITORS AND INDUCERS
19
TABLE 2.
STUDY DRUG
24
TABLE 3.
ADVERSE EVENTS REQUIRING SUPPLEMENTAL REPORTS
27
LIST OF FIGURES
FIGURE 1.
PERIOD 1 SCHEMATIC
13
LIST OF APPENDICES
APPENDIX A.
STUDY-SPECIFIC ABBREVIATIONS AND TERMS
35
APPENDIX B.
RESPONSIBILITIES OF THE INVESTIGATOR
37
APPENDIX C.
LIST OF PROTOCOL SIGNATORIES
38
APPENDIX D.
ACTIVITY SCHEDULE
39
APPENDIX E.
PROTOCOL AMENDMENT SUMMARY OF CHANGES
41

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APPENDIX F.
OPERATIONS MANUAL
43

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2 INTRODUCTION
2.1 Background and Rationale
Why This Study Is Being Conducted
This study will provide data on the long-term safety, tolerability, and efficacy of ABBV-105 and ABBV-599 
in rheumatoid arthritis (RA) subjects who have completed the Phase 2 study of these compounds 
(Study M16-063).  ABBV-105 is a novel, covalent Bruton's tyrosine kinase (Btk) inhibitor being developed 
for the treatment of immune-mediated inflammatory diseases including RA.  ABBV-105 may be given 
alone or in combination with upadacitinib, which is known as ABBV-599.
Btk is a non-receptor tyrosine kinase expressed in multiple immune cell types associated with the 
pathogenesis of RA and other autoimmune diseases.  Btk is required for the propagation of pro-
inflammatory signals downstream of immunoreceptors that promote autoimmune disease 
pathogenesis.  Compared to other Btk inhibitors, such as CC-292 (Celgene) and ibrutinib 
(Pharmacyclics/Janssen), ABBV-105 showed better potency, superior selectivity, and less off-target 
activity, which is considered favorable for administration in humans.
Upadacitinib is a novel Janus kinase (JAK) inhibitor, which displays unique selectivity for the JAK1 
receptor.  Upadacitinib is currently being developed for the treatment of adult patients with moderately 
to severely active RA (Phase 3), psoriatic arthritis (Phase 3), atopic dermatitis (Phase 3), Crohn's disease 
(Phase 3), ulcerative colitis (Phase 2), axial spondyloarthritis (Phase 2), and giant cell arteritis (Phase 2).  
Development of other indications of interest (i.e., dermatomyositis and/or Takayasu arteritis) are under 
discussion.  As of 20 June 2017, a total of 1232 subjects have received upadacitinib, which includes 
469 healthy volunteers, 553 RA patients, and 210 Crohn's disease patients.  Upadacitinib was generally 
well-tolerated, and the types of adverse events (AEs) seen were typical of patients treated with 
immunosuppressant therapies.
ABBV-105 given alone or as the ABBV-599 combination therapy (with upadacitinib) are anticipated to be 
effective in decreasing signs and symptoms associated with active RA in patients with inadequate 
response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs) by interfering 
with the JAK1/Btk pathways.  Concurrent inhibition of JAK1/Btk pathways in RA may increase percent of 
those responding, as well as depth of response (relative to inhibiting either pathway alone), while 
maintaining an acceptable safety profile.
Clinical Hypothesis
The safety and efficacy of ABBV-105 and ABBV-599 will be maintained over an extended period of 
treatment.
2.2 Benefits and Risks to Subjects
Preclinical toxicology studies of ABBV-105 in animals and ex vivo human samples suggest that the 
potential risks to human subjects of ABBV-105 are anemia, bleeding associated with platelet 

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dysfunction, and lymphopenia.  Reductions in lymphocytes and the known mechanism of action suggest 
the potential for an increased susceptibility to infection.
ABBV-105 alone and the ABBV-599 combination therapy (with upadacitinib) were well-tolerated with no 
serious adverse events (SAEs) observed in healthy adult subjects at various doses in 3 Phase 1 studies 
(Studies M16-356, M16-357, and M16-044).  The current study is a continuation of the Phase 2 study of 
ABBV-105 and ABBV-599 in RA (Study M16-063).  Taken together, the safety data from the Phase 1 
program and the safe and successful completion of Study M16-063 support further development of 
ABBV-105 and ABBV-599 in Phase 2 in subjects with RA.  
The data from over 4,000 RA patients treated with upadacitinib support an acceptable safety profile and 
a positive risk-benefit for treatment of adult patients with moderately to severely active RA.  
Data from the primary efficacy analyses of the 5 pivotal Phase 3 clinical studies for the upadacitinib RA 
development program consistently demonstrated the efficacy of upadacitinib 15 mg QD and 30 mg QD, 
with both doses of upadacitinib meeting all primary and ranked key secondary endpoints across all 
studies which included all lines of therapy (methotrexate [MTX]-naïve, conventional synthetic disease-
modifying antirheumatic drug [csDMARD]/MTX-inadequate responder [IR], and biologic disease-
modifying antirheumatic drug [bDMARD]-IR).  Upadacitinib 15 mg QD also demonstrated superiority 
over adalimumab across a broad range of efficacy measures.  Overall, the efficacy data in the RA 
development program provide substantial evidence to support the use of upadacitinib as monotherapy 
or in combination with MTX and/or csDMARDs for the treatment of adults with moderately to severely 
active RA.
Serious infections and herpes zoster are identified risks for upadacitinib therapy.  The rates of serious 
infections and herpes zoster for upadacitinib therapy are within the range of other marketed JAK 
inhibitor products.
In regarding to the potential for malignancy, per upadacitinib Investigator's Brochure version 18.0:
Few malignancies were reported in the controlled portions of the upadacitinib Phase 2 and 3 clinical 
studies precluding any conclusions about rates between treatment groups.  The interim rate of total 
malignancies excluding and including non-melanoma skin cancer (NMSC) on upadacitinib in the Phase 2 
open label extension Study M13-538, which includes long-term treatment data, are both 0.7 E/100 PY.  
The malignancy types reported in the clinical program have been consistent with that anticipated in the 
study population including solid tumors such as breast, prostate and lung cancer, lymphoma, and NMSC.  
A number of subjects with malignancy had pre-existing risk factors for malignancy and/or prior history of 
treatment with other immunosuppressive therapy.
The malignancy rate is higher in the upadacitinib 30 mg group compared to the 15 mg treatment group; 
however, the difference in rates is related to more cases of NMSC and not other malignancy types.
For further details, please see findings from completed studies, including safety data, in the most recent 
ABBV-105 and upadacitinib Investigator's Brochures.
For safety monitoring, the following are included in the protocol:
!
Subjects meeting discontinuation criteria as part of the M16-063 study will be excluded.

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!
If a subject develops a serious infection or opportunistic infection with study treatment, study 
drug should be interrupted, and appropriate treatment of the infection should be initiated.
!
SAEs of infection will be reviewed on a real time basis and queried for additional information as 
clinically indicated.
!
A supplemental herpes zoster form will be used to collect additional information for any herpes 
zoster infections.
3 STUDY OBJECTIVES AND ENDPOINTS
3.1 Objectives
The primary objective of this study is to evaluate the long-term safety, tolerability, and efficacy of 
ABBV-105 and ABBV-599 in RA subjects who have completed Study M16-063.
3.2 Efficacy Endpoints
There is no primary efficacy endpoint since this is the extension to the feeder Study M16-063.  Efficacy 
endpoints for this study, measured at each study visit, include the following:
!
Change in disease activity score (DAS)28 (C-reactive protein [CRP]) from baseline of 
Study M16-063;
!
Proportion of subjects achieving DAS Low Disease Activity (LDA), defined as DAS28 CRP ≤3.2;
!
Proportion of subjects achieving DAS Clinical Remission (CR), defined as DAS28 CRP < 2.6;
!
Change in clinical disease activity index (CDAI) from baseline of Study M16-063;
!
Proportion of subjects achieving LDA based on CDAI criteria, defined as CDAI ≤ 10;
!
Proportion of subjects achieving CR based on CDAI criteria, defined as CDAI ≤ 2.8;
!
Proportion of subjects achieving American College of Rheumatology (ACR) 20/50/70 response.  
A subject will be considered an ACR 20/50/70 responder if:
!
The swollen joint count (SJC) and tender joint count (TJC) have decreased from baseline of 
Study M16-063 by 20/50/70% or more.
!
At least 3 of the 5 remaining ACR core set measures (i.e., Patient's Assessment of Pain [using 
visual analog scale, VAS], Patient Global Assessment of Disease Activity [PtGA], Physician 
Global Assessment of Disease Activity [PhGA], Health Assessment Questionnaire Disability 
Index [HAQ-DI], and high-sensitivity C-reactive protein [hsCRP]) show reduction of 
20/50/70% or more from baseline of Study M16-063.
!
Change in individual components of ACR from baseline of Study M16-063, to include:
!
SJC,
!
TJC,

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!
Patient's Assessment of Pain (using VAS),
!
PtGA,
!
PhGA,
!
HAQ-DI, and
!
hsCRP.
!
Change in Morning Stiffness from baseline of Study M16-063.
3.3 Safety Endpoints
Safety evaluations include AE monitoring, physical examinations, vital sign measurements, 
electrocardiogram (ECG), and clinical laboratory testing (hematology, chemistry, and urinalysis) as a 
measure of safety and tolerability for the entire study duration.
An internal data monitoring committee (DMC) will review unblinded safety data on a cohort level 
throughout the course of the study.  A separate DMC charter has been prepared outside of the protocol 
and describes the roles and responsibilities of the DMC members, frequency of data reviews, relevant 
safety data to be assessed, and expectations for blinded communications.
The DMC will be responsible for safeguarding the interests of trial subjects by assessing the safety and, if 
appropriate, the efficacy data of the interventions during the trial, as well as for monitoring the quality 
and integrity of the clinical trial.  The DMC will provide recommendations to the AbbVie contact about 
stopping, modifying or continuing the trial without modification.  The DMC may also formulate 
recommendations relating to the selection/recruitment/retention of subjects, their management, 
improving adherence to protocol-specified regimens and retention of subjects, and the procedures for 
data management and quality control.
The DMC is a multidisciplinary group consisting of clinicians and biostatisticians who, collectively, has 
knowledge in the management of patients with rheumatoid arthritis (RA) and experience in the conduct 
and monitoring of randomized clinical trials.  The DMC reviews the available safety data, and as 
applicable, the critical efficacy endpoints, assessing risks and benefits, and recommends to the AbbVie 
Contact whether to continue without change, modify, or stop the Study M16-063 clinical trial.
All DMC members will be internal AbbVie members with expertise in clinical safety monitoring and who 
have no affiliation with ABBV-599.  Following initiation of the study, DMC members will have no 
involvement in the conduct of Study M16-063 or other ABBV-599 clinical trials outside their role on the 
DMC.  All DMC members have agreed to not discuss unblinded data with those who have involvement 
with Study M16-063 or ABBV-599 development until the Study M16-063 unblinded information is made 
available to the team.
An independent Cardiovascular Adjudication Committee (CAC) will adjudicate blinded cardiac and 
cerebrovascular events.  A CAC charter has been prepared separately from the protocol and defines
objective, scope, frequency, and triggers of data reviews.
The clinical trial is to be discontinued or terminated in case of an unacceptable risk, relevant toxicity, or 
a negative change in the risk/benefit assessment.  This might include the occurrence of adverse events 

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of which character, severity or frequency is new in comparison to the existing risk profile.  In addition 
any data deriving from other clinical trials or toxicological studies which negatively influence the 
risk/benefit assessment might cause discontinuation or termination of the study.
3.4 Biomarker Research
Optional samples (whole blood, serum, and plasma) will be collected at specific time points as described 
in the Activity Schedule (Appendix D) to evaluate known and or novel disease related or drug related 
biomarkers.  Types of biomarkers may include nucleic acids, proteins, lipids, and/or metabolites.  The 
objective of research is to analyze samples for biomarkers that will help to understand RA, related 
conditions, and response to treatment with ABBV-105 and upadacitinib or similar compounds.  Research 
on samples collected in Germany will be limited to RA, ABBV-105, and upadacitinib.  Research may also 
include changes in epigenetics, gene expression, and proteomics that may be associated with RA, 
related conditions, or the subject's response to treatment.  This research is exploratory in nature, and 
the results may not be included with the clinical study report.
4 INVESTIGATIONAL PLAN
4.1 Overall Study Design and Plan
This is a Phase 2, double-blind, multicenter, long-term extension (LTE) study to assess the safety, 
tolerability, and efficacy of ABBV-105 and ABBV-599 in RA subjects who have completed Study M16-063.  
Subjects who meet eligibility criteria (Section 5.1) and enter the study on ABBV-105, ABBV-599, or 
upadacitinib from Study M16-063 will continue on their previously-assigned treatment through the end 
of the LTE study.  Subjects who meet eligibility criteria and enter the study on placebo for both 
ABBV-105 and upadacitinib from Study M16-063 will receive ABBV-599.  Study drug treatment 
assignments include the following:
!
Group 1:  ABBV-599 (ABBV-105 60 mg and upadacitinib 15 mg) administered once a day (QD),
!
Group 2:  ABBV-105 60 mg and upadacitinib placebo QD,
!
Group 3:  ABBV-105 20 mg and upadacitinib placebo QD
!
Group 4:  ABBV-105 5 mg and upadacitinib placebo QD, and
!
Group 5:  Upadacitinib 15 mg and ABBV-105 placebo QD.
This study plans to enroll subjects who completed Study M16-063 at approximately 39 sites in Canada 
and the European Union.  The number, allocation, and location of sites may vary depending on 
operational aspects of the study.  Study sites and subjects will remain blinded for the duration of the 
study.
The duration of the LTE study will be approximately 52 weeks.  This includes a 48-week double-blind 
treatment period with study visits conducted at Weeks 18, 24, 30, 36, 48, and 60 from the baseline visit 
of Study M16-063.  In addition, subjects will also have a telephone follow-up call 30 days after their last 
visit to determine the status of any ongoing AEs/SAEs or the occurrence of any new AEs/SAEs.

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The schematic of the study is shown in Figure 1.  Further details regarding study procedures are located 
in the Operations Manual.
Figure 1.
Period 1 Schematic
QD = administered once a day
4.2 Discussion of Study Design
Choice of Control Group
Subjects will roll over from Study M16-063 and continue on their originally randomized treatment, with 
the exception of those originally randomized to placebo, who will roll over to ABBV-599.  The objective 
of this LTE study is to evaluate long term safety and efficacy of ABBV-105 and ABBV-599, and thus 
primary comparison will be relative to the safety and efficacy profile observed in each arm during the 
initial randomized study.
Appropriateness of Measurements
Standard statistical, clinical, and laboratory procedures will be utilized in this study.  All efficacy 
measurements in this study are standard for assessing disease activity in subjects with RA.  All clinical 
and laboratory procedures in this study are standard and generally accepted.
Suitability of Subject Population
This LTE study will enroll subjects who have completed Study M16-063.  Only those subjects who have 
met all of the specified eligibility criteria will have an option to enter into the LTE study to receive 

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continued therapy, provided the subject is willing and the investigator believes that continuing therapy 
is appropriate.
Selection of Doses in the Study
Since the study is a continuation of the initial Phase 2 dose exploration study of ABBV-105 and 
ABBV-599, the doses selected for this study are the same as those used previously in Study M16-063.  
These doses were determined based on an analysis of pharmacokinetic, pharmacodynamic, and safety 
data from Phase 1 studies in healthy volunteers for ABBV-105 and Phase 2 and Phase 3 studies for 
upadacitinib, in addition to efficacy data for upadacitinib in RA.
5 STUDY ACTIVITIES
5.1 Eligibility Criteria
Subjects must meet all of the following criteria in order to be included in the study.  Anything other than 
a positive response to the questions below will result in exclusion from study participation.
Consent
1. Subjects or their legally authorized representative 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 screening or study-specific procedures.
Demographic and Laboratory Assessments
2. Subjects have completed Study M16-063 (i.e., the preceding study of ABBV-105 and 
ABBV-599) and have not developed any laboratory or clinical discontinuation criteria as defined 
in that study.
Relevant Study M16-063 eligibility requirements applicable to Study M16-763 are as follows:
a.
Subjects or their legally authorized representative 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 screening or study-specific procedures.
b.
Adult male or female, at least 18 years old.
c.
Laboratory values not meeting toxicity management criteria from the Study M16-063 study:
d.
Diagnosis of RA for ≥ 3 months based on the 2010 ACR/European League Against 
Rheumatism (EULAR) classification criteria for RA.
e.
No history of any of the following cardiovascular conditions:
!
Moderate to severe congestive heart failure (New York Heart Association Class III or IV).
!
Recent history (within past 6 months) of cerebrovascular accident (CVA), myocardial 
infarction, and/or coronary stenting.
!
Uncontrolled hypertension as defined by a persistent systolic blood pressure (BP) 
> 160 mmHg or diastolic BP > 100 mmHg.  For subjects with known hypertension, the 

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subject's BP must be stable for at least 4 weeks on current, stable anti-hypertensive 
medications.
!
Prior unprovoked deep vein thrombosis or pulmonary embolism (PE) (i.e., any 
spontaneous event not directly attributable to trauma or vascular instrumentation).
!
Any other condition which, in the opinion of the Investigator, would put the subject at 
risk by participating in the protocol.
f.
No history of any arthritis with onset prior to age 17 years or current diagnosis of 
inflammatory joint disease other than RA (including but not limited to gout, systemic lupus 
erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis 
and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue 
diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active 
symptoms], or any arthritis with onset prior to age 17 years).  Current diagnosis of 
secondary Sjogren's Syndrome is permitted.
g.
Must not have been treated with any investigational drug, other than those supplied in 
Study M16-063, within 30 days or five half-lives of the drug (whichever is longer) prior to the 
first dose of study drug or is currently enrolled in another clinical study, other than 
Study M16-063.
h.
Females must not be pregnant, breastfeeding, or considering becoming pregnant during the 
study or for approximately 30 days after the last dose of study drug.
i.
For all females of child-bearing potential:  a negative serum pregnancy test at the Screening 
Visit and a negative urine pregnancy test at baseline prior to the first dose of study drug in 
the Study M16-063 study as well as persistently negative urine pregnancy test throughout 
Study M16-063 and at entrance into this study.
j.
Female subjects of childbearing potential must practice at least 1 protocol-specified method 
of birth control that is effective from Study Day 1 through at least 30 days after last dose of 
study drug.  Female subjects of non-childbearing potential do not need to use birth control.
k.
Must not have any active or recurrent viral infection that, based on the Investigator's clinical 
assessment, makes the subject an unsuitable candidate for the study, including hepatitis B 
virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) 
herpes zoster, disseminated (even a single episode) herpes simplex, or human 
immunodeficiency virus (HIV).
Active HBV, HCV, and HIV are defined as:
HBV:  Hepatitis B surface antigen (HBs Ag) positive (+) or, for hepatitis B core antibody (HBc 
Ab) positive subjects, detection of HBV DNA by polymerase chain reaction (PCR);
HCV:  HCV RNA detectable in any subject with anti-HCV antibody (HCV Ab);
HIV:  Confirmed positive anti-HIV antibody (HIV Ab) test.
l.
Must not have active TB or meets TB exclusionary parameters (defined as the presence of 
active TB or latent TB not adequately treated as per protocol requirements).
m. Must not have used known strong cytochrome P450 (CYP)3A or CYP1A2 inhibitors or strong 
CYP3A or CYP1A2 inducers from Screening through the end of the study.

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n.
Must not have had receipt of any live vaccine within 4 weeks prior to the first dose of study 
drug, or expected need of live vaccination during study participation including at least 
4 weeks after the last dose of oral study drug.
o.
Must not have a history of any malignancy except for successfully treated non-melanoma 
skin cancer (NMSC) or localized carcinoma in situ of the cervix.
p.
Must not have a history of clinically significant (per Investigator's judgment) drug or alcohol 
abuse within the last 6 months.
q.
Must not have a history of gastrointestinal perforation (other than appendicitis or 
penetrating injury), diverticulitis or significantly increased risk for gastrointestinal 
perforation per investigator judgment.
r.
Must not have any conditions that could interfere with drug absorption including but not 
limited to short bowel syndrome.
s.
Must not be a recipient of an organ transplant.
t.
Must not have history of clinically significant medical conditions or any other reason that in 
the opinion of the Investigator would interfere with the subject's participation in this study 
or would make the subject an unsuitable candidate to receive study drug.
u.
Must not have had an active infection(s) requiring treatment with parenteral anti-infectives 
within 30 days, or oral anti-infectives within 14 days prior to the first dose of study drug.
v.
Must not have a history of an allergic reaction or significant sensitivity to constituents of the 
study drugs (and its excipients) and/or other products in the same class.
w. Subjects must have been treated for ≥ 3 months with ≥ 1 bDMARD therapy but continue to 
exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of 
treatment duration.
x.
Subjects must have been receiving csDMARD therapy ≥ 3 months prior to Study M16-063 
baseline visit. 
The following csDMARDs are allowed:  oral or parenteral methotrexate (MTX) (7.5 to 
25 mg/week), sulfasalazine (≤ 3000 mg/day), hydroxychloroquine (≤ 400 mg/day), 
chloroquine (≤ 250 mg/day), and leflunomide (≤ 20 mg/day).
A combination of up to two background csDMARDs is allowed EXCEPT the combination of 
MTX and leflunomide.
y.
Subjects must have discontinued all bDMARDs prior to the first dose of study drug.  The 
washout period for bDMARDs prior to the first dose of study drug is specified below or 
should be at least five times the mean terminal elimination half-life of a drug:
≥ 4 weeks for etanercept;
≥ 10 weeks for adalimumab, infliximab, certolizumab, golimumab, tocilizumab, and 
abatacept;
≥ 1 year for rituximab OR ≥ 6 months if B cells have returned to pretreatment level or 
normal reference range (central lab) if pretreatment levels are not available.

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z.
Subjects must have discontinued all high-potency opiates at least 1 week and oral 
traditional Chinese medicine for at least 4 weeks prior to the first dose of study drug (refer 
to Section 5.3 for prohibited medications).
3. Subject is willing and/or able to comply with procedures required in this protocol.
Concomitant Medications
4. Subject must not be currently enrolled in any study (except the preceding Study M16-063) or 
planning to enroll in another interventional clinical study while participating in this study.
5. Subject must not require vaccination with any live vaccine during study participation, 
including at least 30 days after the last dose of study drug.
5.2 Contraception Recommendations
Contraception Requirements for Females
Subjects must follow the following contraceptive guidelines as specified:
!
Females, Non-Childbearing Potential
Females do not need to use birth control during or following study drug treatment if considered 
of non-childbearing potential due to meeting any of the following criteria:
!
Postmenopausal, age > 55 years with no menses for 12 or more months without an 
alternative medical cause.
!
Postmenopausal, age ≤ 55 years with no menses for 12 or more months without an 
alternative medical cause AND a follicle-stimulating hormone (FSH) level > 40 IU/L.
!
Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or 
hysterectomy).
!
Females, of Childbearing Potential
Females of childbearing potential must avoid pregnancy while taking study drug(s) and for at 
least 30 days after the last dose of study drug.  Females must commit to one of the following 
methods of birth control:
!
Combined (estrogen and progestogen containing) hormonal birth control (oral, intravaginal, 
transdermal, injectable) associated with inhibition of ovulation initiated at least 1 month 
prior to study Baseline Day 1.
!
Progestogen-only hormonal birth control (oral, injectable, implantable) associated with 
inhibition of ovulation initiated at least 1 month prior to study Baseline Day 1.
!
Bilateral tubal occlusion/ligation (can be via hysteroscopy, provided a hysterosalpingogram 
confirms success of the procedure).
!
Intrauterine device (IUD).
!
Intrauterine hormone-releasing system (IUS).

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!
To have a vasectomized partner(s) (the vasectomized partner[s] has received medical 
assessment of the surgical success and is the sole sexual partner of the trial subject).
!
To practice true abstinence (if acceptable per local guidelines), defined as:  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).
If required per local practices, male or female condom with or without spermicide OR cap, diaphragm, 
or sponge with spermicide should be used in addition to one of the highly effective birth control 
methods listed above (excluding true abstinence).  A condom is required in the following countries:  UK, 
Germany, and Spain.
Concomitant conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) (i.e., MTX, 
sulfasalazine, etc.) have been prescribed per standard of care prior to study entry and are allowed to be 
continued during the study.  Contraception should continue while the subject is on the concomitant 
csDMARD(s) and that duration of contraception after discontinuation of the csDMARD(s) should be 
based on the local label.  Additional local requirements may apply.
5.3 Prohibited Medications and Therapy
JAK Inhibitor
Initiation of any new JAK inhibitors (including, but not limited to, tofacitinib [Xeljanz®], baricitinib 
[Olumiant®], and filgotinib) is not allowed.
Corticosteroids
Oral corticosteroids > 10 mg prednisone/day or equivalent and intra-articular, intramuscular, 
intravenous, trigger point or tender point, intra-bursa, and intra-tendon sheath corticosteroids are NOT 
allowed during this study except as described in Section 5.4 (Prior and Concomitant Therapy) for 
treatment of an RA flare, as defined by the investigator.
Any csDMARD/Immunosuppressive Therapy Not Listed in Section 5.4 (Prior and Concomitant Therapy)
All biologic therapies are prohibited during the study.  Examples of biologic therapies include but are not 
limited to the following:
!
Humira® (adalimumab)
!
Enbrel® (etanercept)
!
Remicade® (infliximab)
!
Kineret® (anakinra)
!
Rituxan® (rituximab)
!
Cimzia® (certolizumab pegol)
!
Simponi® (golimumab)

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!
Actemra® (tocilizumab)
!
Raptiva® (efalizumab)
!
Tysabri® (natalizumab)
!
Stelara® (ustekinumab)
!
Benlysta® (belimumab)
!
Orencia (abatacept)
Strong CYP3A or CYP1A2 Inhibitors or Inducers
Systemic use of known strong inhibitors or inducers of CYP3A or CYP1A2 is excluded from the Screening 
Visit through the end of the study.  The most common strong CYP3A or CYP1A2 inhibitors and inducers 
are listed in Table 1.
Table 1.
Examples of Commonly Used Strong CYP3A or CYP1A2 Inhibitors and Inducers
Strong CYP3A Inhibitors
Strong CYP3A Inducers
Boceprevir
Cobicistat
Clarithromycin
Conivaptan
Grapefruit (fruit or juice)
Indinavir
Itraconazole
Ketoconazole
Lopinavir/Ritonavir
Mibefradil
Nefazodone
Nelfinavir
Posaconazole
Ritonavir
Saquinavir
Telaprevir
Telithromycin
Troleandomycin
Voriconazole
Carbamazepine
Phenytoin
Rifampin
Rifapentine
St. John's Wort
Strong CYP1A2 Inhibitors
Strong CYP1A2 Inducers
Fluvoxamine
Ciprofloxacin
Enoxacin
Zafirlukast
Rifampin
Live Vaccines
Use of live vaccines is prohibited during the study and must be avoided for four weeks after the last 
dose of study drug.  Examples of live vaccines include, but are not limited to, the following:

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!
Monovalent live influenza A (H1N1) (intranasal);
!
Seasonal trivalent live influenza (intranasal);
!
Herpes zoster;
!
Rotavirus;
!
Varicella (chicken pox);
!
Measles-mumps-rubella or measles mumps rubella varicella;
!
Oral polio vaccine;
!
Smallpox;
!
Yellow fever;
!
Bacille Calmette-Guérin (BCG);
!
Typhoid.
5.4 Prior and Concomitant Therapy
Subjects should continue on their previous background csDMARD therapy from Study M16-063, 
restricted to the following:  oral or parenteral methotrexate (7.5 to 25 mg/week), sulfasalazine 
(≤3000 mg/day), hydroxychloroquine (≤ 400 mg/day), chloroquine (≤ 250 mg/day), and/or leflunomide 
(≤ 20 mg/day).  Combinations of up to two csDMARDs are allowed except for the combination of MTX 
and leflunomide.
At any time, the csDMARD dose may be decreased for safety reasons.  Subjects taking MTX should take 
a dietary supplement of oral folic acid (or equivalent, such as folinic acid) throughout study 
participation.  Folic acid dosing and timing of regimen should be followed according to Investigator's 
instructions.  AbbVie will not provide the csDMARDs (or folic acid, if taking MTX).
Subjects should continue on their stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs), 
acetaminophen/paracetamol, oral corticosteroids (equivalent to prednisone ≤ 10 mg/day), or inhaled 
corticosteroids.
!
If taking any of the above on a scheduled basis, subjects should continue to take them as they 
did at study entry with no change in dose or frequency, including on study visit days.
!
If subject was not taking any of the above at baseline, these must not be initiated except where 
permitted by protocol (i.e., after Week 18).
!
If taking any of the above, including low-potency analgesics (i.e., tramadol, codeine, 
hydrocodone, or propoxyphene) at baseline on an as-needed (PRN) basis, subjects should 
continue to use them for the same reason and same dose each time, but they should not be 
taken within the 24 hours prior to any study visit to avoid bias in outcome measurements.
Calculation of the Clinical Disease Activity Index (CDAI) is required to determine if a subject fails to 
achieve LDA.  Calculation of CDAI will be performed at the Week 18 visit by Interactive Response 

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Technology (IRT) with input from site personnel on joint counts and PtGA and PhGA score.  The 
calculation used to determine CDAI score at Week 18 is as follows:
CDAI = TJC28 + SJC28 + PtGA (cm) + PhGA (cm)
Beginning at Week 18, subjects who fail to achieve CDAI ≤ 10 should have background medication(s) 
adjusted or initiated.  Initiation of or change in corticosteroids, NSAIDs, or acetaminophen, or 
adding/increasing csDMARD doses (restricted to oral or parenteral MTX, sulfasalazine, 
hydroxychloroquine, chloroquine, and leflunomide, except for the combination of MTX and 
leflunomide), is allowed as per local label and at investigator discretion.  If necessary, a burst of systemic 
corticosteroids (maximum dose of 0.5 mg/kg of prednisone or its equivalent) is allowed, after which 
subject should resume their usual daily oral corticosteroid dose.
Intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, and intra-tendon 
sheath injections of corticosteroids, at dosage and frequency per standard of care, are allowed after the 
Week 18 assessments have been performed and at time points thereafter.  For the analysis of the TJC 
and SJC, injected joints will be considered "not assessable" for 3 months from the time of the intra-
articular injection.
In the event of tolerability (or other safety) issues, the doses of these medications may be decreased or 
discontinued with substitution of another permitted medication from that class.  PRN use of inhaled 
corticosteroids is permitted at any time.
Study drug interruption is allowed up to 30 consecutive days.  If the subject undergoes elective surgery, 
the study drug should be interrupted 2 weeks prior to the planned surgery.  If the subject must undergo 
emergency surgery, the study drug should be interrupted at the time of surgery.  In either case, study 
drug may be reintroduced once the physician has examined the surgical site and determined that it has 
healed and there is no sign of infection.
Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, and/or 
herbal supplements) that the subject receives during the study should be recorded through the follow-
up phone call 30 days after the last treatment visit (Week 60).
Any questions regarding concomitant or prior therapy should be raised to the AbbVie emergency 
contact.  Information regarding potential drug interactions with ABBV-105 or ABBV-599 can be located 
in the ABBV-105 or upadacitinib Investigator's Brochures.
5.5 Withdrawal of Subjects and Discontinuation of Study
A subject may voluntarily withdraw or be withdrawn from the study at any time for reasons including, 
but not limited to, the following:
!
Clinically significant abnormal laboratory results or AEs, which rule out continuation of the study 
drug, as determined by the investigator or the AbbVie Therapeutic Area Medical Director.
!
Serious infections (e.g., sepsis) that cannot be adequately controlled within 2 weeks by anti-
infective treatment or would put the subject at risk for continued participation in the trial as 
determined by the Investigator.

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!
The investigator believes it is in the best interest of the subject.
!
The subject requests withdrawal from the study.
!
Eligibility criteria violation was noted after the subject started study drug and continuation of 
the study drug would place the subject at risk.
!
Introduction of prohibited medications or dosages and continuation of the study drug would 
place the subject at risk.
!
Subject is non-compliant with tuberculosis (TB) prophylaxis (if applicable) or develops active TB 
at any time during the study.
!
The subject becomes pregnant while on study drug.
!
Malignancy, except for localized NMSC or carcinoma in-situ of the cervix.
!
Subject is significantly noncompliant with study procedures, which would put the subject at risk 
for continued participation in the trial.
!
Subject develops a gastrointestinal perforation.
In addition, the following discontinuation criteria also apply:
!
Subjects not responding to therapy can discontinue study drug (or withdraw from study) at any 
time for any reason during the study in order to receive standard of care.
!
Subjects who demonstrate worsening of joint count (SJC and/or TJC) at 2 consecutive visits 
(scheduled or unscheduled) should be discontinued from study drug and treated with standard 
of care at the discretion of the clinician.
!
Starting at the Week 18 visit (after the Week 18 assessments have been performed) and at visits 
thereafter, subjects who fail to achieve at least 20% improvement in TJC and SJC should be 
discontinued.
!
Starting at the Week 18 visit (after the Week 18 assessments have been performed) and at visits 
thereafter, subjects who fail to achieve CDAI ≤ 10 should have background medication(s) 
adjusted or initiated (i.e., initiation of or change in corticosteroids, NSAIDs, acetaminophen or 
adding or increasing doses in csDMARDs [restricted to oral or parenteral MTX, sulfasalazine, 
hydroxychloroquine, chloroquine and leflunomide except the combination of MTX and 
leflunomide is allowed as per local label]).
!
Starting at the Week 18 visit (after Week 18 assessments have been performed) and at visits 
thereafter, intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa,
and intra-tendon sheath injections of corticosteroids, dosage and frequency per standard of 
care are allowed.  For the analysis of the TJC and SJC, injected joints will be considered "not 
assessable" for 3 months from the time of the intra-articular injection.
!
Starting at the Week 24 visit and at visits thereafter, subjects achieving 20% improvement in TJC 
and SJC but not achieving CDAI ≤10 should be considered for discontinuation to standard of care 
at the discretion of the clinician.

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Subjects who prematurely discontinue study drug should complete a Premature Discontinuation (PD) 
Visit as soon as possible, preferably within 2 weeks of discontinuation.  See Section 5.6 for information 
regarding early discontinuation.
For subjects to be considered lost to follow-up, reasonable attempts must be made to obtain 
information on the subject's final status.  At a minimum, 2 telephone calls must be made and 1 certified 
letter must be sent and documented in the subject's source documentation.
AbbVie may terminate this study prematurely, either in its entirety or at any site.  The investigator may 
also stop the study at his/her site if he/she has safety concerns.  If AbbVie terminates the study for 
safety reasons, AbbVie will promptly notify the investigator.
5.6 Follow-Up for Subject Withdrawal from Study
To minimize missing data for efficacy and safety assessments, subjects who prematurely discontinue 
study drug treatment should continue to be followed for all regularly scheduled visits, unless subjects 
have decided to discontinue the study participation entirely (withdrawal of informed consent).  Subjects 
should be advised on the continued scientific importance of their data even if they discontinue 
treatment with study drug early.
Following discontinuation of study drug, the subject should be treated in accordance with the 
investigator's best clinical judgment irrespective of whether the subject decides to continue
participation in the study.  In addition, all future rescue- and efficacy-driven discontinuation criteria no 
longer apply.  This includes 20% TJC/SJC calculations at Weeks 12 through 24, Weeks 36 through 40 and 
Week 48 and thereafter, as well as CDAI calculation at Week 26, if applicable.  If at any point a subject 
no longer wants to provide assessments (withdrawal of informed consent) following discontinuation of 
study drug, a second PD visit is not required.
If a subject prematurely discontinues study participation (withdrawal of informed consent), the 
procedures outlined for the PD visit should be completed as soon as possible, preferably within 2 weeks.  
In addition, if subject is willing, a 30-day follow-up phone call after the last dose of study drug may be 
completed to ensure all treatment-emergent AEs/SAEs have been resolved.
All attempts must be made to determine the date of the last study drug dose and the primary reason for 
discontinuation of study drug or study participation.  The information will be recorded on the 
appropriate electronic case report form (eCRF) page.  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.  Following discontinuation of study drug, the subject should 
be treated in accordance with the Investigator's best clinical judgment irrespective of whether the 
subject decides to continue participation in the study.
If a subject withdraws from the main study, biomarker research samples will continue to be stored and 
analyzed.  A subject must contact the study investigator if they no longer want their samples to be 
stored and analyzed.  Once AbbVie is notified, no new information will be collected, no new analysis will 
be started, and the samples will be destroyed unless a regulatory authority requires AbbVie to keep 
them.  However, if AbbVie (or people or companies working with AbbVie) collected any information or 

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AbbVie will not supply drug other than ABBV-105, upadacitinib, and matching placebo for this study.  
ABBV-105, upadacitinib, and matching placebo will be packaged in bottles with quantities sufficient to 
accommodate study design.  Each kit will be labeled per local requirements, and this label must remain 
affixed to the kit.  Upon receipt, study drug should be stored as specified on the label and kept in a 
secure location.
Each kit will contain a unique kit number.  This kit number is assigned to a subject via interactive 
response technology (IRT) and encodes the appropriate study drug to be dispensed at the subject's 
corresponding study visit.  Site staff will complete all blank spaces on the label before dispensing to 
subjects.  Study drug will only be used for the conduct of this study.
5.8 Randomization/Drug Assignment
All subjects were assigned a unique identification number by the IRT at the screening visit for 
Study M16-063.  Subjects who enter the study on active ABBV-105 and/or upadacitinib from 
Study M16-063 will continue on their previously-assigned treatment through the end of the LTE study.  
Subjects who previously received placebo treatment during Study M16-063 will receive ABBV-599 in the 
LTE study.
All AbbVie personnel with direct oversight of the conduct and management of the trial (with the 
exception of AbbVie Drug Supply Management Team), the investigator, study site personnel, and the 
subject will remain blinded to each subject's treatment throughout the study.  To maintain the blind, the 
ABBV-105 capsules and matching placebo capsules and upadacitinib tablets and matching placebo 
tablets provided for the study will be identical in appearance.
In the event of a medical situation that requires unblinding of the study drug assignment, the 
Investigator is requested to contact the AbbVie Therapeutic Area Medical Director prior to breaking the 
blind.  However, if an urgent therapeutic intervention is necessary which warrants breaking the blind 
prior to contacting the AbbVie Therapeutic Area Medical Director, the Investigator can directly access 
the IRT system via the Unblind Subject transaction, which is available to the Investigator.  If the IRT 
system is unavailable, unblinding may occur by contacting EndPoint technical support via either phone 
(preferred) or email (support@endpointclinical.com).  For country-specific phone numbers, please see 
the following website:  http://www.endpointclinical.com/help-desk/.  In the event that the blind is 
broken before notification to the AbbVie Therapeutic Area Medical Director, we request that the AbbVie 
Therapeutic Area Medical Director be notified within 24 hours of the blind being broken.  
5.9 Protocol Deviations
The investigator is responsible for complying with all protocol requirements, written instructions, and 
applicable laws regarding protocol deviations.  Protocol deviations are prohibited except when 
necessary to eliminate an immediate hazard to study subjects.  If a protocol deviation occurs (or is 
identified), the investigator is responsible for notifying the IEC/IRB, regulatory authorities (as 
applicable), and AbbVie.

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6 SAFETY CONSIDERATIONS
6.1 Complaints and Adverse Events
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.  Complaints associated with any component of this investigational 
product must be reported to AbbVie.
Product Complaints
A product complaint is any complaint 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 (e.g., printing illegible), missing components/product, device not working properly, 
or packaging issues.
Product complaints concerning the investigational product and/or device must be reported to AbbVie 
within 1 business day of the study site's knowledge of the event.  Product complaints occurring during 
the study will be followed up to a satisfactory conclusion.
Medical Complaints/Adverse Events and Serious Adverse Events
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject 
administered a pharmaceutical product and which does not necessarily have a causal relationship with 
this treatment.  An AE 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.
The investigators will monitor each subject for clinical and laboratory evidence of AEs on a routine basis 
throughout the study.  All AEs will be followed to a satisfactory conclusion.
An elective surgery/procedure scheduled to occur during a study will not be considered an AE 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 AE.
If any of the following AEs in Table 3 are reported, the following supplemental report(s) must be 
completed.

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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.
All AEs reported from the time of study drug administration until 30 days after discontinuation of study 
drug administration will be collected, whether solicited or spontaneously reported by the subject.  In 
addition, SAEs and protocol-related nonserious AEs will be collected from the time the subject signs the 
study-specific informed consent.
AbbVie will be responsible for Suspected Unexpected Serious Adverse Reactions (SUSAR) reporting for 
the Investigational Medicinal Product (IMP) in accordance with global and local requirements.
AEs will be monitored throughout the study to identify any of special interest that may indicate a trend 
or risk to subjects.
Adverse Events of Special Interest
The following adverse events of special interest (AESI) will be monitored during the study:
!
Serious infections
!
Opportunistic infections
!
Herpes zoster
!
Tuberculosis
!
Malignancy (all types)
!
Gastrointestinal perforations
!
Adjudicated cardiovascular events (e.g., major adverse cardiovascular event [MACE])
!
Anemia
!
Neutropenia

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!
Lymphopenia
!
Increased serum creatinine and renal dysfunction
!
Hepatic events and increased hepatic transaminases
!
Elevated creatine phosphokinase
!
Embolic and thrombotic events (non-cardiac, non-CNS)
Adverse Event Severity and Relationship to Study Drug
The investigator will rate the severity of each AE according to the Rheumatology Common Toxicity 
Criteria v.2.0.  If no grading criteria are provided for the reported event, then the event should be 
graded as follows:
!
Mild (Grade 1):  Asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated.
!
Moderate (Grade 2):  Minimal, local or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living (ADL) (instrumental ADL refer to preparing 
meals, shopping for groceries or clothes, using the telephone, managing money, etc.).
!
Severe (Grade 3):  Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL (self 
care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden);
!
Life-threatening (Grade 4):  Urgent intervention indicated or death related to AE.
The investigator will use the following definitions to assess the relationship of the AE to the use of study 
drug:
Reasonable Possibility – After consideration of factors including timing of the event, biologic plausibility, 
clinical judgment, and potential alternative causes, there is sufficient evidence (information) to suggest 
a causal relationship.
No Reasonable Possibility – After consideration of factors including timing of the event, biologic 
plausibility, clinical judgment, and potential alternative causes, there is insufficient evidence 
(information) to suggest a causal relationship.
Pregnancy
While not an AE, pregnancy in a study subject must be reported to AbbVie within 1 working day after 
the site becomes aware of the pregnancy.  Subjects who become pregnant must be discontinued 
(Section 5.5).  Information regarding the pregnancy and the outcome will be collected.
The pregnancy outcome of an elective or spontaneous abortion, stillbirth, or congenital anomaly is 
considered a SAE and must be reported to AbbVie within 24 hours after the site becomes aware of the 
event.

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6.2 Toxicity Management
The management of specific AEs and laboratory parameters is described in the Operations Manual.
The toxicity management of AEs, including AESIs, consists of safety monitoring (review of AEs on an 
ongoing basis and periodic/ad hoc review of safety issues by a data monitoring committee [DMC]), 
interruption of study drug dosing with appropriate clinical management (if applicable), and 
discontinuation of the subjects from study drug.  The management of specific AEs and laboratory 
parameters is described below.
For subjects who have had study drug discontinued and are instead on standard of care therapies, these 
toxicity management requirements do not apply (including alerts from the central lab), and any 
intolerability to standard of care therapies should be managed by the prescribing physician.
Serious Infections: Subjects should be closely monitored for the development of signs and symptoms of 
infection during and after treatment with study drug.  Study drug should be interrupted if a subject 
develops a serious infection or an opportunistic infection.  A subject who develops a new infection 
during treatment with study drug should undergo prompt diagnostic testing appropriate for an 
immunocompromised subject.  As appropriate, antimicrobial therapy should be initiated, and the 
subject should be closely monitored.  Study drug may be restarted once the infection has been 
successfully treated.  Subjects who develop active TB or experience hepatitis B reactivation must be 
discontinued from study drug.  To further monitor subjects for serious infections, subjects will complete 
at-home weekly temperature monitoring.  If above 100.5 degrees Fahrenheit (38 degrees Celsius), 
subject should inform their study doctor to assess the need for further evaluation. 
Subjects should be advised to follow local public health guidelines in order to prevent subjects enrolled 
in these trials from acquiring TB. 
Serious Gastrointestinal Events:  Subjects presenting with the onset of signs or symptoms of a serious 
gastrointestinal event should be evaluated promptly for early identification of gastrointestinal 
perforation.  If the diagnosis of gastrointestinal perforation is confirmed, the subject must be 
discontinued from study drug.
Cardiovascular Events (MACE):  Subjects presenting with potential cardiovascular events should be 
carefully monitored.  These events will be reviewed and adjudicated by the independent CAC in a 
blinded manner.
Malignancy:  Subjects who develop malignancy other than NMSC or carcinoma in situ of the cervix must 
be discontinued from study drug.  Information, including histopathological results, should be queried for 
the confirmation of the diagnosis.
ECG Abnormality: Subjects must be discontinued from study drug for an ECG change considered 
clinically significant and with reasonable possibility of relationship to study drug OR a confirmed 
absolute QT interval corrected for heart rate using Fridericia's correction formula (QTcF) value 
> 500 msec.
Management of Select Laboratory Abnormalities:  For any given laboratory abnormality, the 
Investigator should assess the subject and apply the standard of care for medical evaluation and 

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treatment following any local guidelines.  Specific toxicity management guidelines for abnormal 
laboratory values are described in the operations manual and may require an appropriate supplemental 
eCRF be completed.  All abnormal laboratory tests that are considered clinically significant by the 
Investigator will be followed to a satisfactory resolution.  If a repeat test is required, the repeat testing 
must occur as soon as possible.
7 STATISTICAL METHODS & DETERMINATION OF SAMPLE SIZE
7.1 Statistical and Analytical Plans
Complete and specific details of the statistical analysis will be described and fully documented in the 
Statistical Analysis Plan (SAP).  The SAP will be finalized prior to the database lock.  The statistical 
analyses will be performed using SAS (SAS Institute Inc., Cary, North Carolina, USA).
7.2 Definition for Analysis Populations
The Full Analysis Set (FAS) includes all subjects who completed Study M16-063 and received at least 
1 dose of assigned study drug in Study M16-763.  The FAS will be used for efficacy and baseline analyses.  
Subjects will be grouped according to treatments as randomized for Study M16-063.
The Safety Analysis Set also includes all subjects who completed Study M16-063 and received at least 
one dose of assigned study drug in Study M16-763.  Subjects will be grouped according to treatments 
actually received in Study M16-763.  The Safety Analysis Set will be used for safety analyses.  
7.3 Statistical Analyses for Efficacy
Analysis of efficacy endpoints will be conducted on the FAS based on treatments as randomized for 
Study M16-063.  The analysis will be based on As Observed data, and no imputation will be conducted.  
The analysis treatment groups will be described as follows indicating from Study M16-063 to extension 
Study M16-763:
!
Group 1:  ABBV-599 to ABBV-599
!
Group 2:  ABBV-105 60 to 105 60 mg
!
Group 3:  ABBV-105 20 to 105 20 mg
!
Group 4:  ABBV-105 5 to 105 5 mg
!
Group 5:  Upadacitinib 15 to Upadacitinib 15 mg, and
!
Group 6:  Placebo to ABBV-599
!
Group 7:  All ABBV-599 (Group 1 and 6)
The baseline for all efficacy analyses in this study will be the baseline in Study M16-063.

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There is no primary efficacy endpoint and no formal statistical tests will be applied.  Only descriptive 
statistics will be used for all efficacy endpoints.  Descriptive statistics will be provided for each treatment 
group for all visits.  These include the number of observations, mean with 95% confidence interval, 
standard deviation, median, minimum and maximum for continuous endpoints (or the change from 
baseline measurements), and frequencies and percentages with 95% confidence interval for binary 
endpoints.  
No missing data imputation will be applied.  All efficacy analyses will be based on As Observed analysis, 
and thus a subject who does not have an evaluation at the primary analysis time point will not be 
included.
Details on efficacy analyses are provided in the SAP.
Sample Size Estimation
This is the LTE study for Study M16-063.  All eligible subjects who completed Study M16-063 will be 
enrolled in this study if the subject signs and dates the informed consent.  Based on discontinuation 
criteria mandating efficacy, it is estimated that 20 - 60% of subjects (i.e., between 40 and 120 subjects) 
will ultimately complete the LTE.
7.4 Statistical Analyses for Safety
All safety analyses will be performed in the Safety Analysis Set.
All treatment-emergent adverse events (TEAEs), SAEs, AEs leading to discontinuation, and AESI will be 
collected during the study.  A TEAE is defined as an event with onset or worsening after the first study 
dose of study drug and within 30 days after the last dose of study drug administration.  The number and 
percentages of subjects experiencing TEAEs will be tabulated using the Medical Dictionary for Drug 
Regulatory Activities (MedDRA®) system organ class and preferred term.  Summaries (including 
percentages and event per 100 patient-year) of SAEs, deaths, AEs leading to discontinuation, and AESI 
will be provided as well.  For selected laboratory and vital signs parameters, mean change from baseline 
and percentage of subject with evaluations meeting pre-defined criteria for Potentially Clinically 
Important values will be summarized.
7.5 Interim Analysis
An unblinded interim analysis to review long-term safety and efficacy will be conducted after the 
Study M16-063 unblinded Week 12 database lock and analysis.  The descriptive statistics will be 
presented for key efficacy and safety endpoints with all available data at the interim analysis.  Detailed 
interim analyses are provided in the SAP.

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8 ETHICS
8.1 Independent Ethics Committee/Institutional Review Board
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the IEC/IRB for review and approval.  Approval of both the protocol and the informed 
consent form(s) must be obtained before any subject is enrolled.  Any amendment to the protocol will 
require review and approval by the IEC/IRB before the changes are implemented to the study.  In 
addition, all changes to the consent form(s) will be IEC/IRB approved.
8.2 Ethical Conduct of the Study
The study will be conducted in accordance with the protocol, Operations Manual, International Council 
for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (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 investigator are specified in 
Appendix B.
8.3 Subject Confidentiality
To protect subjects' confidentiality, all subjects and their associated samples will be assigned numerical 
study identifiers or "codes."  No identifiable information will be provided to AbbVie.
9 SOURCE DOCUMENTS AND CASE REPORT FORM 
COMPLETION
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported.  All source documents should be attributable, legible, contemporaneous, original, 
accurate, and complete to ensure accurate interpretation of data.  Clinical site monitoring is conducted 
to ensure that the rights and well-being of human subjects are protected, that the reported trial data 
are accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the 
currently approved protocol, ICH Good Clinical Practice (GCP), and applicable local regulatory 
requirement(s).
10 DATA QUALITY ASSURANCE
AbbVie will ensure that the clinical trial is conducted with a quality management system that will define 
quality tolerance limits in order to ensure human subject protection and reliability of study results.  Data 
will be generated, documented, and reported in compliance with the protocol, ICH GCP, and applicable 
regulatory requirements.

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11 COMPLETION OF THE STUDY
The investigator will conduct the study in compliance with the 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 submit, maintain, and archive any records related to the study according to ICH 
GCP and all other applicable regulatory 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 accordance with the European Medicines Agency Guidance 
on Investigator's Signature for Study Reports.
The end of study is defined as the date of the last subject's last contact, which will be a follow-up phone 
call 30 days after the last dose.

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APPENDIX A. STUDY-SPECIFIC ABBREVIATIONS AND TERMS
ACR
American College of Rheumatology
AE
adverse event
ADL
activities of daily living
AESI
adverse event(s) of special interest
ALT
alanine aminotransferase
AST
aspartate aminotransferase
BCG
Bacille Calmette-Guérin
bDMARD
biologic disease-modifying antirheumatic drug
Btk
Bruton's tyrosine kinase
CAC
Cardiovascular Adjudication Committee
CDAI
Clinical Disease Activity Index
CNS
central nervous system
CR
clinical remission
CRP
C-reactive protein
csDMARD
conventional synthetic disease-modifying antirheumatic drug
CYP1A2
cytochrome P450 1A2 isoform
CYP3A
cytochrome P450 3A isoform
DAS
disease activity score
DAS28
disease activity score (28 joints)
DMC
data monitoring committee
ECG
electrocardiogram
eCRF
electronic case report form
EudraCT
European Clinical Trials Database
FAS
full analysis set
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
HAQ-DI
Health Assessment Questionnaire Disability Index
HBV, HCV
hepatitis B virus, hepatitis C virus
HIV
human immunodeficiency virus
hsCRP
high-sensitivity C-reactive protein
ICH
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use

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IEC
independent ethics committee
IGRA
interferon gamma release assay
IMP
Investigational Medicinal Product
IRB
institutional review board
IRT
interactive response technology
IU
International Unit
IUD
intrauterine device
IUS
intrauterine hormone-releasing system
JAK
Janus kinase
LDA
low disease activity
LTE
long-term extension
MACE
major adverse cardiovascular event
MedDRA
Medical Dictionary for Regulatory Activities
MTX
methotrexate
NMSC
non-melanoma skin cancer
NSAID
nonsteroidal anti-inflammatory drug
PD
premature discontinuation
PhGA
Physician's Global Assessment of Disease Activity
PtGA
Patient's Global Assessment of Disease Activity
PRN
as needed (pro re nata)
QD
once a day
QTc
corrected QT
QTcF
Fridericia-corrected QT interval
RA
rheumatoid arthritis
RNA
ribonucleic acid
SAE
serious adverse event
SAP
statistical analysis plan
SJC
swollen joint count
SUSAR
Suspected Unexpected Serious Adverse Reaction
TB
tuberculosis
TEAE
treatment-emergent adverse event
TJC
tender joint count
ULN
upper limit of normal
VAS
visual analog scale

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APPENDIX B. RESPONSIBILITIES OF THE INVESTIGATOR
Protocol M16-763:  ABBV-105, Given Alone or in Combination with Upadacitinib (ABBV-599), in Adult 
Subjects with Active Rheumatoid Arthritis Who Have Completed a Preceding Phase 2 Randomized 
Controlled Trial
Protocol Date:  06 February 2020
Clinical research studies sponsored by AbbVie are subject to the International Council for Harmonisation 
of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practices (GCP) and 
local regulations and guidelines governing the study at the site location.  In signing the Investigator 
Agreement, the investigator is agreeing to the following:
1.
Conducting the study in accordance with ICH GCP, the applicable regulatory requirements, 
current protocol and operations manual, and making changes to a protocol only after notifying 
AbbVie and the appropriate Institutional Review Board (IRB)/Independent Ethics Committee 
(IEC), except when necessary to protect the subject from immediate harm.
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., IEC or IRB) review and approval of the protocol and its amendments.
4.
Reporting complaints that occur in the course of the investigation(s) to AbbVie.
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 protocol and all of its amendments.
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. Providing direct access to source data documents for study-related monitoring, audits, IEC/IRB 
review, and regulatory inspection(s).
Signature of Principal Investigator
Date
Name of Principal Investigator (printed or typed)

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APPENDIX C. LIST OF PROTOCOL SIGNATORIES
Name
Title
Functional Area
Immunology
Clinical Program Development
Study Project Management
Data and Statistical Sciences
Data and Statistical Sciences
Clinical Pharmacology and 
Pharmacometrics
Medical Writing

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APPENDIX E. PROTOCOL AMENDMENT SUMMARY OF 
CHANGES
Previous Protocol Version
Protocol 
Date
Version 1.0
06 August 2018
Version 1.1 (Canada Only)
12 October 2018
Version 2.0
12 October 2018
Version 2.1 (VHP)
17 December 2018
Version 3.0
17 January 2019
!
Added CDAI efficacy endpoints to Section 3.2.
Rationale:  To add endpoints that use a disease activity index that is not influenced by CRP, 
who's synthesis by the liver is directly blocked by JAK inhibition.
!
Added further detail to Eligibility Criterion 2j in Section 5.1.
Rationale:  To clarify proper birth control practices that are to be followed during the study.
!
Removed "relative to baseline from Study M16-063" from discontinuation criteria around 
worsening of SJC and/or TJC, subjects failing to achieve at least 20% improvement in SJC and TJC 
starting at Week 18, and subjects who fail to achieve CDAI ≤10 starting at Week 18
(Section 5.5).
Rationale:  To clarify discontinuation criteria.
!
Added further detail to study drug discontinuation instructions in Section 5.6.
Rationale:  To ensure study drug discontinuation processes are clear.
!
Added clarification to the study drug dispensation instructions in Section 5.7.
Rationale:  To ensure that study drug is properly dispensed.
!
Added information around the Safety Analysis set to Section 7.2 and Section 7.4.
Rationale:  To clarify the Safety Analysis Set parameters.
!
Added an All ABBV-599 efficacy analysis set and clarifying language in Section 7.3.
Rationale:  To run an efficacy analysis on all subjects who received study drug.
!
Added an Interim Analysis (Section 7.5).
Rationale:  To explain the planned, unblinded interim analysis that will be conducted after the 
Study M16-063 Week 12 database lock.
!
Removed Troponin and Troponin + CK MB testing from Section 3.11 of the Operations Manual 
(Protocol Appendix F).

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Rationale:  Asymptomatic CPK elevation is a known JAK inhibitor class effect and is described in 
the Rinvoq USPI and SmPC.  Testing asymptomatic subjects with more specific tests designed 
only for those with suspicion for myocardial infarction (CK-MB and troponin is not warranted and 
may lead to unnecessary cardiac evaluations and patient anxiety).
!
Added clarification around which type of herpes zoster vaccine the instructions are referring to 
in Section 3.11 of the Operations Manual (Protocol Appendix F).
Rationale:  To ensure it's understood that this requirement only applies to those taking a live 
herpes zoster vaccine.
!
Remove reference to liver biopsies from Section 4.1 of the Operations Manual (Protocol 
Appendix F).
Rationale:  To clarify that there are no liver biopsies at Screening or any time during the Study.
In addition to these modifications, the Amendment contains the following minor changes:
Update Section 2.1 to align with current upadacitinib development program.
Update wording in Section 2.1 and Section 2.2 for clarity.
Update wording in Section 3.3 to clarify that separate DMC and CAC charters have been prepared 
outside of the protocol.
Update wording around study drug discontinuation in Section 6.2 for clarity.
Update Sponsor/Emergency Medical Contact throughout.
Update to protocol signatories (Appendix C, List of Protocol Signatories).
Added Appendix F to align with the updated AbbVie Protocol template.
Update abbreviations throughout for consistency.

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APPENDIX F. OPERATIONS MANUAL