An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)
Conditions: Crohn's Disease, Rheumatoid Arthritis, Psoriasis
Sponsor: AbbVie

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Title Page
Title
An ObserVatIonal STudy of the Effectiveness of 
AdaLimumab on Health and Disability Outcomes in New 
Zealand Patients with Immune-Mediated InflammaTorY
Diseases (VITALITY)
Protocol Version 
Identifier
P15-345
Date of Last Version of 
Protocol
21 April 2015
EU PAS Register 
Number
Not registered
Marketing 
Authorisation Holder(s) 
AbbVie Limited
Research Question and 
Objectives
The objective of this study is to assess the effect of 
adalimumab on health and disability outcomes in patients 
with the immune-mediated inflammatory diseases of
rheumatoid arthritis, Crohn’s disease and psoriasis. 
Country of Study
New Zealand
Author
This study will be conducted in compliance with this protocol.
Confidential Information 
No use or disclosure outside AbbVie is permitted without prior written authorization 
from AbbVie. 

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Marketing Authorisation Holder(s)
Marketing Authorisation Holder(s)
AbbVie Limited
L6, 156–158 Victoria Street
Wellington
PO Box 11437, Manners Street
Wellington
NEW ZEALAND

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1.0
Table of Contents
1.0 
Table of Contents.....................................................................3 
2.0 
Abbreviations...........................................................................5 
3.0 
Responsible Parties..................................................................6 
4.0 
Abstract ....................................................................................9 
5.0 
Amendments and Updates....................................................12 
6.0 
Milestones...............................................................................13 
7.0 
Rationale and Background...................................................13 
8.0 
Research Question and Objectives ......................................15 
8.1 
Hypothesis................................................................................................15 
9.0 
Research Methods .................................................................15 
9.1 
Study Design............................................................................................15 
9.1.1 
Schedule of Events...................................................................................18 
9.2 
Setting ......................................................................................................21 
9.2.1 
Inclusion Criteria: ....................................................................................23 
9.2.2 
Exclusion Criteria: ...................................................................................23 
9.3 
Investigator Selection Criteria .................................................................24 
9.4 
Variables ..................................................................................................24 
9.5 
Data Sources ............................................................................................25 
9.5.1 
Questionnaires: ........................................................................................25 
9.5.2 
Physician completed assessments............................................................27 
9.6 
Study Size ................................................................................................27 
9.7 
Data Management ....................................................................................27 
9.7.1 
Data Collection ........................................................................................27 
9.7.2 
Data Correction........................................................................................28 
9.7.3 
Source Documentation.............................................................................28 
9.8 
Data Analysis...........................................................................................29 
9.8.1 
Definitions................................................................................................29 
9.8.1.1 
Participant Population..............................................................................29 
9.8.1.2 
Observational Period................................................................................29 
9.8.2 
Statistical Analyses ..................................................................................29 

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9.8.3 
Demographic and Baseline Characteristics .............................................30 
9.8.4 
Primary Efficacy Analyses.......................................................................30 
9.8.5 
Secondary Efficacy Analyses...................................................................30 
9.8.6 
Safety Analyses........................................................................................31 
9.8.7 
Additional Analyses.................................................................................31 
9.9 
Missing Data ............................................................................................32 
9.10 
Interim Analysis.......................................................................................32 
9.11 
Quality Control ........................................................................................32 
9.12 
Limitations of the Research Methods ......................................................33 
9.13 
Other Aspects...........................................................................................33 
9.13.1 
Note To File .............................................................................................33 
9.13.2 
Training Log ............................................................................................33 
9.13.3 
Visitor Log...............................................................................................33 
9.13.4 
Responsibilities of the Principal Investigator ..........................................33 
9.13.5 
End of Trial..............................................................................................33 
10.0 
Protection of Human Subjects..............................................34 
11.0 
Management and Reporting of Adverse 
Events/Adverse Reactions.....................................................34 
11.1 
Adverse Event Definition and Serious Adverse Event Categories..........34 
11.2 
Severity ....................................................................................................36 
11.3 
Relationship to Pharmaceutical Product ..................................................36 
11.4 
Serious Adverse Event Collection Period................................................37 
11.5 
Serious Adverse Event Reporting............................................................37 
11.6 
Pregnancy Reporting................................................................................37 
12.0 
Plans for Disseminating and Communicating Study 
Results.....................................................................................37 
13.0 
References...............................................................................38 
Annex 1. 
Study Questionnaires ............................................................39 

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Abbreviations
CDAI
Crohn’s Disease Activity Index
CRF
Case Report Form
CRP
C-Reactive Protein
DLQI
Dermatology Life Quality Index
EU
European Union
FPFV
First Patient First Visit
FPLV
First Patient Last Visit
GCP
Good Clinical Practice
HAQ-DI
Health Assessment Questionnaire–Disability Index
ICH
International Conference on Harmonization
IEC
Independent Ethics Committee
IMID
Immune-Mediated Inflammatory Diseases 
IRB
Independent Review Board
K10
Kessler Psychological Distress Scale 
LPFV
Last Patient First Visit
LPLV
Last Patient Last Visit
PASI
Psoriasis Area and Severity Index
PDF
Portable Document Format
PP
Per Protocol
PPD
Purified Protein Derivative
PRO
Patient-Reported Outcomes
QoL
Quality of Life
RA
Rheumatoid Arthritis
RAP
Reporting and Analysis Plan
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SD
Standard Deviation
SIBDQ
Short Inflammatory Bowel Disease Questionnaire
SOP
Standard Operating Procedure
TNF
Tumour Necrosis Factor
WHODAS 2.0
The World Health Organisation Disability Assessment Schedule
2.0
WPAI:GH
The Work Productivity and Activity Impairment Questionnaire: 
General Health V2.0

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3.0
Responsible Parties
Sponsor
AbbVie Limited
L6, 156–158 Victoria Street
Wellington
PO Box 11437, Manners Street 
Wellington
New Zealand
Sponsor’s Responsible Person
Principal Investigator:
Clinical Project Manager
Monitoring CRO

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Study-Designated Physician

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PROTOCOL SIGNATURES
Investigator Signature:
I have read and agree to the Protocol Number P15-345, “An Observational Study of the 
Effectiveness of Adalimumab on Health and Disability Outcomes in New Zealand 
Patients with Immune-Mediated Inflammatory Diseases”. I am aware of my 
responsibilities as an investigator under the guidelines of Good Clinical Practices, local 
laws and regulations (as applicable) and the study protocol. I agree to conduct the study 
according to these laws and guidelines and to appropriately direct and assist the staff 
under my control, who will be involved in the study.
Principal (Site) Investigator:
Name (typed or printed):
Institution and Address:
Telephone Number:
Signature:
Date:
(Day/ Month /Year)
Full investigational site contact details, including telephone numbers, will be documented 
in the Study Master File.

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Abstract
Title: An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and 
Disability Outcomes in New Zealand Patients with Immune-Mediated InflammaTorY
Diseases (VITALITY)
Rationale and Background: For public health purposes disability is becoming 
increasingly important as an outcome measure. Despite this, there are few data on the 
effectiveness of adalimumab on disability outcomes in patients with Immune-Mediated 
Inflammatory Diseases (IMIDs), particularly in the Phase IV setting. There are even 
less data available in New Zealand, which did not have the opportunity to participate to 
a major extent in large, multinational, Phase III pivotal studies of adalimumab in 
IMIDs. 
The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a 
simple, validated, free and easy-to-use generic assessment instrument for health and 
disability. It is applicable across cultures, in all adult populations. It is a responsive 
measure that can show what difference a treatment makes.
Results from study of effect of adalimumab on WHODAS scores and other Patient-
Reported Outcomes (PRO) of work activity and well-being will be of interest to a 
variety of stakeholders in the healthcare system including patients, healthcare 
practitioners and payers.
Research Question and Objectives: The objective of this study is to assess the effect 
of adalimumab on health and disability outcomes in patients with the immune-
mediated inflammatory diseases of rheumatoid arthritis, Crohn’s disease and psoriasis.
Study Design:
This is a Phase IV, parallel-group, observational, multicentre study 
designed to investigate the effectiveness of adalimumab on health and disability 
outcomes in New Zealand patients diagnosed with, rheumatoid arthritis, Crohn’s 
disease and psoriasis.
Overall, a minimum of approximately 190 subjects with IMIDs are planned to be 
enrolled in the study at up to 15 sites. Approximately 80 subjects will be enrolled into 
each of 2 parallel study groups of patients diagnosed with rheumatoid arthritis or
Crohn’s disease. A minimum of 30 subjects with psoriasis will also be enrolled. All 
subjects will receive at least 3 months of treatment with adalimumab. Continuation of 
adalimumab will depend upon the patient meeting “Special Authority” response 
criteria between 3 and 6 months, which will allow continuing reimbursement of drug 
supply. 
To assess health and disability outcomes, the WHODAS 2.0 score will be assessed at 
baseline, 2, 4 and 6 months after treatment initiation with adalimumab. In addition, 
other PROs of work activity and well-being, including the Work Productivity and 
Activity Impairment Questionnaire: General Health (WPAI:GH) V2.0, Kessler 

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Psychological Distress Scale (K10), Flourishing Scale, Subject Vitality Scale will also 
be administered at these time points. Disease-specific PROs that are commonly used in 
clinical practice (Health Assessment Questionnaire–Disability Index [HAQ-DI], Short 
Inflammatory Bowel Disease Questionnaire [SIBDQ], Dermatology Life Quality Index 
[DLQI]), will also be assessed. Variations of these disease–specific indices were used 
in some of the pivotal Phase III studies for adalimumab.
Population: Subjects will be males and/or females who are attending a routine clinical 
visit and meet all of the inclusion criteria and none of the exclusion criteria.
Inclusion Criteria: 
1. Male and female
2. 18 to 75 years of age, inclusive.
3. Patients with a diagnosis of rheumatoid arthritis, Crohn’s disease or psoriasis 
who have made a decision with their physician to commence treatment with 
adalimumab in accordance with routine medical practice and with the approved 
adalimumab New Zealand datasheet.
4. Patients who have been evaluated for tuberculosis risk factors/exposure for 
active/latent tuberculosis infection (per local requirements and according to the 
approved adalimumab New Zealand Datasheet).
5. Subject has voluntarily signed and dated an informed consent form prior to any 
study-specific procedures.
Exclusion Criteria: 
1.   Previous treatment with adalimumab
2.   Previous treatment with any biologic
3.   Severe infection including sepsis, active tuberculosis or opportunistic infection. 
4.   Moderate to severe heart failure (New York Heart Association Class II/III) 
5.   Concurrent administration with anakinra 
6.   Hypersensitivity to adalimumab or its excipients
7.   Any condition that in the opinion of the investigator would compromise the 
subject’s well-being or ability to perform the study requirements.
Variables: The primary outcome variable is change in WHODAS 2.0 response score 
at 6 months compared to baseline. Secondary outcome variables include WHODAS 2.0 
response score at 2 and 4 months compared to baseline and other PRO measures of 
work activity and well-being, outlined above, at all study time points compared to 
baseline.

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Data Sources: Case Report Forms (CRFs). Collection of data includes but not limited 
to subject demographics, adverse events, serious adverse events and concomitant 
medications. The following questionnaires will be utilized to collect data directly from 
participating subjects:
x
WHODAS 2.0
x
WPAI:GH V2.0
x
K10
x
Flourishing Scale
x
Subject Vitality Scale
x
Disease-specific PROs that are commonly used in clinical practice (HAQ-DI, 
SIBDQ, DLQI)
Study Size:
It is anticipated that the three groups will respond differently to 
adalimumab treatment over the study period and there is reason to believe that these 
groups will be different at baseline. Therefore, the sample size will be powered for 
rheumatoid arthritis and Crohn’s disease. Approximately 80 subjects will be enrolled 
into each of these 2 parallel study groups allowing for detection of within participant 
effect sizes of approximately 0.40 as statistically significant (2-WDLOHG Į  ZLWK
90% power. A minimum of 30 subjects with psoriasis will also be enrolled. A 
minimum number of 190 patients will be enrolled into the study.
Data Analysis: Primary Endpoint Analysis
Change in total WHODAS 2.0 score at 6 months after the initiation of adalimumab, in 
those patients continuing on adalimumab (responder population), across all indications. 
This change will be summarised as the mean and 95% confidence interval and will be 
tested with a paired t-test. 
Secondary Endpoint Analyses
x
Change in disease-specific indices (HAQ-DI, SIBDQ, DLQI), WPAI:GH, K10, 
Flourishing Scale, Subject Vitality Scale at 2, 4 and 6 months after the initiation 
of adalimumab, in those patients continuing on adalimumab (responder 
population). These changes will be summarised as the means and 95% 
confidence intervals and will be tested with paired t-tests.
x
Change in total WHODAS 2.0 score at 6 months after the initiation of 
adalimumab, in those patients continuing on adalimumab (responder 
population), compared with those patients not continuing on adalimumab (non-
responders). The mean changes in these two groups will be compared using an 
independent t-test.

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5.0
Amendments and Updates
Number
Date
Section of Study 
Protocol
Amendment or 
Update
Reason
1
16SEP2015
x Title Page
x Milestones
x Study Design
x Setting
x Management 
and Reporting 
of Adverse 
Events
x Addition of 
acronym to 
study title
x Update 
milestones 
based on FSFD
x Addition of 
guidance on 
discontinuation 
of individual 
subjects
x Addition of 
requirement 
around TB 
screening to 
inclusion 
criteria
x Clarification to
Schedule of 
Events
x Addition of 
requirement 
around 
reporting of 
non-serious 
adverse events 
of malignancy 
LQSDWLHQWV
years of age
x Increase 
physician recall 
of study
x Updated 
timelines
x Process has 
been unclear
x
Observational 
study –
Requirement for 
TB screening 
should follow 
local 
requirements 
and according 
to the approved 
adalimumab 
New Zealand 
Datasheet
x
Clarification of 
what is required 
at Baseline and 
timing of 
questionnaires
x
Global 
Regulatory 
requirement 
A detailed summary of the changes is included in Annex 2.

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6.0
Milestones
Major study milestones and their planned dates are as follows:
Start of Data Collection (FPFV):
06 July 2015
End of Data Collection:
06 September 2016
Database Lock:
20 September 2016
Interim Database Lock:
01 March 2016
Interim Report:
31 March 2016
Final Report of Study Results:
11 November 2016
7.0
Rationale and Background
Disability has been defined as impairments, activity limitations and participation 
restrictions due to personal and environmental factors (1). The concept of disability is one 
where a physical health condition or disease is evaluated in terms of its impact, 
difficulties, or limitations on a range of tasks, activities, or roles that are considered 
typical of everyday life. Examples of affected activities include basic aspects of daily 
living such as eating, bathing, dressing, household chores and meal preparation, or 
participation in society, or participation in work.
Along with traditional indicators of a population’s health status, such as mortality and 
morbidity rates, disability has become increasingly important in measuring disease 
burden. Measuring disease activity and health-related quality of life (HRQOL) has 
become standard in many outcome studies, yet measures of disability are less commonly 
used. A complex interaction exists between all three of these elements.
The number of people with disabilities is growing (2). This is because populations are 
ageing – older people have a higher risk of disability – and because of the global increase 
in chronic health conditions associated with disability, such as the Immune-Mediated 
Inflammatory Diseases (IMIDs) of Crohn’s disease, rheumatoid arthritis, and psoriasis.
Uncontrolled active rheumatoid arthritis causes joint damage, disability, decreased quality 
of life, and cardiovascular and other comorbidities (3). Likewise, patients with active 
Crohn’s disease may experience repeat hospital admissions, multiple operations, poor 
nutrition, and malignancy, which can have a major impact on patients’ education, work, 
and social and family life (4). Psoriasis is characterized by a combination of inflammation 

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and epidermal thickening, resulting in thick, scaly skin patches, leading to a significant 
impairment of quality of life and profound psychosocial disability (5).
Adalimumab is a recombinant human immunoglobulin (IgG1) monoclonal antibody
exclusively containing human peptide sequences. Adalimumab binds to tumour necrosis 
factor (TNF) and neutralises the biological function of TNF by blocking its interaction 
with the p55 and p75 cell surface TNF receptors. TNF is a naturally occurring cytokine 
that is involved in normal inflammatory and immune responses. Elevated levels of TNF 
are found in the synovial fluid of rheumatoid arthritis, including juvenile idiopathic 
arthritis, psoriatic arthritis and ankylosing spondylitis patients and play an important role 
in both the pathologic inflammation and the joint destruction that are hallmarks of these 
diseases. Increased levels of TNF are also found in psoriasis plaques, which contribute to 
the inflammatory response, to the proliferation and decreased maturation of keratinocytes 
and to the associated vascular damages that are characteristic of the disease (6).
Adalimumab has multiple registered indications in New Zealand across the therapeutic 
areas of rheumatology, gastroenterology and dermatology (rheumatoid arthritis, 
polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, 
Crohn’s disease, ulcerative colitis and psoriasis) and is subsidized by the New Zealand 
Government in some of these conditions, according to “Special Authority” criteria, which 
relate to disease severity. Registration and approval for subsidy were based on the results 
of a number of large, multinational, Phase III pivotal studies of adalimumab in IMIDs. 
The primary outcomes in these studies were effects of treatment on disease activity and 
health-related quality of life. 
The World Health Organization Disability Assessment Schedule (WHODAS) 2.0 is a 
simple, validated, free- and easy-to-use generic assessment instrument for health and 
disability. It is applicable across cultures, in all adult populations. It is a responsive 
measure that can show what difference treatment makes (7).
The objective of this study is to assess the effect of adalimumab on health and disability 
outcomes in New Zealand patients with the IMIDs of rheumatoid arthritis, Crohn’s 
disease and psoriasis. Results from study of the effect of adalimumab on WHODAS and 
other measures of work activity and well-being will be of interest to a variety of 
stakeholders in the healthcare system including patients, healthcare practitioners and 
payers in New Zealand.

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8.0
Research Question and Objectives
The objective of this study is to assess the effect of adalimumab on health and disability 
outcomes in patients with the immune-mediated inflammatory diseases of rheumatoid 
arthritis, Crohn’s disease, and psoriasis. The effect of adalimumab on health and disability 
outcomes in these patients will be assessed by the primary outcome measure which is the 
change in total WHODAS 2.0 (7) score at 6 months after the initiation of adalimumab, 
across all indications. It will also be assessed by the secondary outcome measures which 
are changes to the WPAI:GH V2.0 score (8), K10 score (9), Flourishing Scale (10) and 
Subject Vitality Scale (11) score at 6 months after the initiation of adalimumab, across all 
indications.
8.1
Hypothesis
Adalimumab treatment will improve disability in subjects with rheumatoid arthritis,
Crohn’s disease, and psoriasis.
9.0
Research Methods
9.1
Study Design
This is a Phase IV, parallel-group, observational, multicentre study designed to investigate 
the effectiveness of adalimumab on health and disability outcomes in New Zealand 
patients diagnosed with rheumatoid arthritis, Crohn’s disease and psoriasis.
The decision to commence treatment with adalimumab is to be made by the patient and 
the physician before including the patient in this study and has to be clearly separated and 
independent of the decision to include the patient in the study.
Overall, a minimum of approximately 190 subjects with these three IMIDs are planned to 
be enrolled in the study at up to 15 sites. Approximately 80 subjects will be enrolled into 
each of 2 parallel study groups of patients diagnosed with rheumatoid arthritis or Crohn’s 
disease. A minimum of 30 subjects with psoriasis will also be enrolled. All subjects will 
receive at least 3 months of treatment with adalimumab. AbbVie is not supplying 
adalimumab; adalimumab is to be used according to the approved adalimumab New 
Zealand Datasheet and is to be prescribed by the physician under usual and customary 
practice of physician prescription. Continuation of adalimumab will depend upon the 
patient meeting the disease-specific response criteria as determined by the investigator

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between 3 and 6 months, which will allow continuing reimbursement of drug supply
under “Special Authority”.
To assess health and disability outcomes, the WHODAS 2.0 score will be assessed at 
baseline, 2, 4 and 6 months after treatment initiation with adalimumab. Work productivity 
will be assessed at these time points using the WPAI:GH V2.0 (8). Psychological distress 
will be measured using the K10 scale (9). Subject happiness will also be measured,
Flourishing Scale (10), Subject Vitality Scale (11). Disease-specific patient reported 
outcomes (PROs) that are more commonly used in clinical practice; Health Assessment 
Questionnaire–Disability Index (HAQ-DI) (12), Short Inflammatory Bowel Disease 
Questionnaire (SIBDQ) (13), Dermatology Life Quality Index (DLQI) (14) will also be 
assessed. Variations of these disease–specific indices were used in some of the pivotal 
Phase III studies for adalimumab.
As this is a non-interventional, observational study, no restrictions on dose modification 
or concomitant medications will be imposed at any time throughout the course of the 
study. Administration of adalimumab and follow up visits will be carried out according to 
investigators’ normal practice.
Primary Endpoint
Change in total WHODAS 2.0 score at 6 months after the initiation of adalimumab, across 
all indications. 
Secondary Endpoints
x
Change in total WHODAS score 2 and 4 months after the initiation of adalimumab 
across all indications 
x
Change in total WHODAS score 6 months after the initiation of adalimumab in 
each indication
x
Changes in WPAI:GH V2.0 Scores, K10 scale, Flourishing Scale, Subject Vitality 
Scale at 6 months after the initiation of adalimumab, across all indications
x
Change in disease-specific scores (HAQ-DI, SIBDQ, DLQI) at 6 months after the 
initiation of adalimumab, in each indication
x
Proportion of patients at 6 months who remain on adalimumab, having satisfied 
the requirements for application for renewal of subsidy by “Special Authority”:
o
5KHXPDWRLG DUWKULWLV  GHFUHDVH LQ DFWLYH MRLQW FRXQW IURP EDVHOLQH
AND a clinically significant response to treatment in the opinion of the 
physician
o
Crohn’s disease: Crohn's Disease Activity Index (CDAI) score reduction 
E\SRLQWVRU&'$,VFRUH

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o
Psoriasis: Psoriasis Area and Severity Index (PASI) score reduction of 
RULQWKHFDVHRIDSDWLHQWKDGVHYere chronic plaque psoriasis of the 
face, or palm of a hand or sole of a foot at the start of treatment, the patient 
has a reduction in the PASI symptom subscores for all 3 of erythema, 
WKLFNQHVVDQGVFDOLQJWRVOLJKWRUEHWWHU25UHGXFWLRQLQDIIHFted 
skin area.
No restriction on current standard of care is imposed. Physicians should treat their patients 
as they would in their routine clinical practice. Prior medical history, the use of any 
concomitant medication and any and all adverse events will be captured and recorded in 
the CRF. 
As all procedures will be conducted in accordance with routine medical practice, 
participation in the study does not convey any additional risks for the subject. However, 
the subject will be provided with information on the benefits and risks of their medical 
treatment by the physician, in accordance with their routine medical practice. 
Prior to collecting any study related information, written informed consent must be 
obtained.
Each subject has the right to withdraw from the study at any time.  In addition, the 
investigator may discontinue a subject from the study at any time if the investigator 
considers it necessary for any reason, including the occurrence of an adverse event or
noncompliance with the protocol.  
In the event that a subject withdraws or is discontinued from the study, the primary reason 
for discontinuation and any other reason(s) for the discontinuation from the study will be 
recorded. If the reason for treatment discontinuation is due to a serious adverse event, it 
should be reported to AbbVie within 24 hours of physician's awareness.
Subjects will be withdrawn from the study immediately if any of the following occur:
•
The investigator believes it is in the best interest of the subject.
•
The subject or subject's guardian requests withdrawal from the study.
•
A selection criteria violation was noted after the subject started adalimumab.
The study procedures to be conducted (if part of routine clinical practice) are outlined in 
the schematic presented in Table 1

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9.1.1
Schedule of Events
Table 1. Study Activities- Clinic Visits (Day 1/Baseline Through 6 months)
Activity
Baseline (Day 1)a
Any time 
point between 
3-6 months
Inclusion/Exclusion Criteria
X
Informed Consent
X
Demographics†
Medical History*
X
TB History Assessmentb
X
Concomitant Medications, Including Changes to
X
X
CRP (if available)c
X
X
Physician’s Assessment of Disease Activity: Active joint count, or CDAI, or PASI
X
X
Adverse Eventsd
X
X
† Once the physician has determined that the patient is eligible for inclusion, and the patient has agreed to be included in the observational study, the patient's 
demographic data (including year of birth, gender, ethnicity) will be recorded on the CRFs at the Baseline visit
*The physician will determine the patient's current health status and obtain a complete medical history including history of tobacco, date of diagnosis, disease 
activity, concomitant medications and TB exposure/risk factors at the Baseline visit.

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Table 2. Study Activities- Patient Activities (Day 1/Baseline Through 6 months)
Activity
Baseline (Day 1)a
2 months
4 months
6 months
WHODAS 2.0 12-item version, self-administered
X
X
X
X
Disease-specific patient reported outcomes: HAQ-DI or SIBDQ or DLQI
X
X
X
X
Kessler Psychological Distress Scale (K10)
X
X
X
X
Work Productivity and Activity Impairment Questionnaire
X
X
X
X
Flourishing Scale
X
X
X
X
Subject Vitality Scale
X
X
X
X
a.
The Baseline visit date will serve as the reference for all subsequent visits. A ± 7 day window is permitted around scheduled study visits, however at 
Baseline patient questionnaires must be completed prior to the first dose of adalimumab.
b.
An assessment of TB exposure/risk factors for active and latent TB (per local requirements and according to the approved adalimumab NZ Datasheet) 
must have been completed prior to the first dose of adalimumab with documented history of results
c.
CRP will only be collected if procedure is performed as part of the usual standard of care
d.
Collection of adverse events begins the day the Subject signs the informed consent

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Figure of study design:
*Disease-specific measure of response to treatment:
•
Active joint count, or CDAI, or PASI
**PRO questionnaires (all self-administered):
•
WHODAS 2.0 12-item version
•
WPAI:GH V2.0 
•
K10
•
Flourishing Scale
•
Subject Vitality Scale
•
Disease-specific outcomes: HAQ-DI or SIBDQ or DLQI
9.1.2
Physician’s assessment of disease activity: Active joint 
count, or CDAI, or PASI 
An assessment of disease activity by the Physician will be recorded at the Baseline Visit 
and within 3–6 months of initiation, as per standard of care.
9.1.3
PRO Questionnaires
Patients will complete the following questionnaires at the visits identified on the Study 
Activities Table (Table 1). 

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x
WHODAS 2.0 
x
WPAI:GH V2.0
x
K10
x
Flourishing Scale
x
Subject Vitality Scale
x
A Disease-Specific patient reported outcome questionnaire:
o
HAQ-DI for patients with rheumatoid arthritis 
o
SIBDQ for patients with Crohn’s disease  
o
DLQI for patients with psoriasis  
At the Baseline visit, the questionnaires must be completed before the first dose of 
adalimumab.
9.1.4
Adalimumab dosing
The participating Physician will provide the patient with a prescription for adalimumab,
along with instructions for appropriate use. The date of first dose of adalimumab will be 
recorded in the CRF and should closely align with the Baseline visit, but not before 
completion of the PRO questionnaires.  
9.1.5
Product Supply
Adalimumab will be obtained as commercially available medication. AbbVie will not
provide the medication for this study.
9.2
Setting
The study will take place in New Zealand with multiple centres across the country. The 
study population shall comprise of male and/or female patients who are attending a 
routine clinical visit and meet all of the inclusion criteria and none of the exclusion 
criteria. Overall, a minimum of approximately 190 subjects with the three IMIDs are 
planned to be enrolled in the study at up to 15 sites.

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As part of the inclusion criteria, the subjects will come from three clinically diagnosed 
areas:
x
rheumatoid arthritis (80 patients)
x
Crohn’s disease (80 patients)
x
psoriasis (30 patients)
The approved indications for the use of adalimumab in New Zealand for treatment of 
these conditions are as follows:
Rheumatoid Arthritis
Humira is indicated for reducing signs and symptoms, as well as inhibiting the 
progression of structural damage in adult patients with moderate to severely active 
rheumatoid arthritis. This includes the treatment of patients with recently diagnosed 
moderate to severely active disease who have not received methotrexate.
Humira can be used alone or in combination with methotrexate. 
&URKQ¶V'LVHDVHLQ$GXOWVDQG&KLOGUHQ\HDUV
Humira is indicated for the treatment of moderate to severe Crohn’s disease to reduce the 
signs and symptoms of the disease and to induce and maintain clinical remission in 
patients;
• who have had an inadequate response to conventional therapies, or,
• who have lost response to or are intolerant of infliximab.
Psoriasis
Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in 
adult patients who are candidates for systemic therapy or phototherapy.
AbbVie is not supplying adalimumab; adalimumab is to be used according to the 
approved adalimumab New Zealand Datasheet and is to be prescribed by the physician 
under usual and customary practice of physician prescription. To be eligible to receive 
New Zealand Government-subsidised access to adalimumab for these conditions, patients 
must meet certain “Special Authority” criteria, as defined by the Pharmaceutical 
Management Agency (PHARMAC). These criteria for initiation of adalimumab therapy 
are detailed in the inclusion/exclusion criteria. For continuation of subsidised access to 
adalimumab documentation of response to treatment must also be made.
It is the Investigator’s responsibility to ensure that all inclusion/exclusion criteria are met. 
Subject selection may be completed by use of a relevant record (e.g. checklist of 
inclusion/exclusion criteria). Site personnel should thoroughly assess the eligibility 
criteria and evidence of this should be stored with the source documentation at site.

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Where there is any deviation from the inclusion/exclusion criteria, the patient should be 
excluded from the study.
9.2.1
Inclusion Criteria: 
1. Male and female
2. 18 to 75 years of age, inclusive.
3. Patients with a diagnosis of rheumatoid arthritis, Crohn’s disease or psoriasis who 
have made a decision with their physician to commence treatment with adalimumab in 
accordance with routine medical practice and with the approved adalimumab New 
Zealand datasheet.
4. Patients who have been evaluated for tuberculosis risk factors/exposure for 
active/latent tuberculosis infection (per local requirements and according to the 
approved adalimumab New Zealand Datasheet).
5. Subject has voluntarily signed and dated an informed consent form, prior to any study-
specific procedures.
9.2.2
Exclusion Criteria: 
1. Previous treatment with adalimumab
2. Previous treatment with any biologic
3. Severe infection including sepsis, active tuberculosis or opportunistic infection. 
4. Moderate to severe heart failure (New York Heart Association Class II/III) 
5. Concurrent administration with anakinra 
6. Hypersensitivity to adalimumab or its excipients
7. Any condition that in the opinion of the investigator would compromise the subject’s 
well-being or ability to perform the study requirements.
The duration of the study will be up to 6 months. Study visits are Screening/Baseline (Day 
1) and 2 months, 4 months and 6 months.
There is a ± seven (7) day window for all study visits. An effort will be made to bring 
subjects back to their original scheduled visit (calculated from Baseline) if they are out of 
the visit window for more than one visit.
For subjects who discontinue from the study prematurely a phone call will be made 30
days after the last dose of adalimumab is administered to obtain follow-up information on 
any ongoing or new adverse events.

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9.2.3
Discontinuation of Individual Subjects: 
Each subject has the right to withdraw from the study at any time.  In addition, the 
investigator may discontinue a subject from the study at any time if the investigator 
considers it necessary for any reason, including the occurrence of an adverse event.  If the 
reason for treatment discontinuation is due to a serious adverse event, it should be 
reported to AbbVie within 24 hours of physician's awareness. 
In the event that a subject withdraws or is discontinued from the study, the primary reason 
for discontinuation and any other reason(s) for the discontinuation from the study will be
recorded. Following discontinuation of the study drug, the patient will be treated in 
accordance with the Investigator's best clinical judgment.
For subjects who discontinue from the study prematurely a phone call will be made 30 
days after the last dose of adalimumab is administered to obtain follow-up information on 
any ongoing or new adverse events.
Subjects will be withdrawn from the study immediately if any of the following occur:
x
The investigator believes it is in the best interest of the subject.
x
The subject or subject's guardian requests withdrawal from the study.
x
A selection criteria violation was noted after the subject started study drug.
9.3
Investigator Selection Criteria
Selection of investigators will be made based on qualification by training and experience. 
Confirmation of adequate resources to properly conduct the trial according to the protocol 
will be obtained through site evaluation/selection visit prior to study initiation and a 
signed copy of the investigator agreement page of this protocol.
9.4
Variables
The primary outcome variable is change in WHODAS 2.0 response score at 6 months 
compared to Baseline. 
Secondary outcome variables include WHODAS 2.0 response score at 2 and 4 months 
compared to Baseline and other PRO scores of work activity and well-being at all study 
time points compared to Baseline.

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Pre-specified safety variables include subject demographics (age, ethnicity, smoking 
status etc.) serious adverse events (SAEs), adverse events, adverse events leading to 
discontinuation, concomitant vital signs, and pregnancy outcomes.
9.5
Data Sources
Designated investigator staff will collect data required by the protocol on paper Case 
Report Forms (CRFs). Collection of data includes but not limited to subject 
demographics, adverse events, serious adverse events and concomitant medications. 
Designated investigator staff should not enter any data until they have completed 
appropriate training. The sites are requested to send a copy of the CRF (scanned copy is 
acceptable) through to the Data Manager to enter into the database within 10 working 
days. Where there are discrepancies with the data, data clarification forms should be 
raised for the designated investigator staff to clarify and return to the Sponsor.
9.5.1
Questionnaires:
Subject self-assessment questionnaires will be utilized in this study to determine patients’ 
improvement over time. Patients will require Internet access as the questionnaires are 
administered electronically through an online portal. For patients unable to utilize the 
online questionnaires paper-and-pencil versions of questionnaires will be provided and 
can be self-administered in person in a quiet and private area of the clinic. In addition, for 
subjects completing paper and pencil versions, the questionnaires can be administered 
over the telephone if the questionnaire time-point does not coincide with a clinic visit.
Data collected via paper and pencil versions of the questionnaires will be transcribed by 
site staff into the online portal on behalf of the patient. Data will be retrieved directly by 
the Data Manager for analysis. Based on a pilot evaluation of the study questionnaires in a 
small number of patients, they are expected to take approximately 10 minutes per visit, 
per subject, to administer. Patients should ensure that their subject number and the date  
the questionnaire was completed is entered onto the questionnaire.
Each patient will complete six (6) common questionnaires at Baseline, Month 2, Month 4 
and Month 6:
x
WHODAS 2.0
o
Covers six different domains: cognition, mobility, self-care, getting along, 
life activities and participation.
o
Does not have a set cut point to define disability
o
12 items

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x
WPAI:GH V2.0
o
This questionnaire looks at the effect of health problems on ability to work 
and perform regular activities.
o
Time missed from work, impairment of work
o
6 items
x
K10
o
Intended to yield a global measure of distress based on questions about 
anxiety and depressive symptoms that a person has experienced in the most 
recent 4 week period.
o
Strong psychometric properties
o
10 items
x
Flourishing Scale
o
Eight items describing important aspects of human functioning ranging 
from positive relationships, to feelings of competence, to having meaning 
and purpose in life.
x
Subject Vitality Scale
o
The state of feeling alive and alert - to having energy available to the self.
o
7 items
x
A Disease-Specific patient reported outcome questionnaire:
o
HAQ-DI for patients with rheumatoid arthritis

Developed as a comprehensive measure of functional status in 
patients with a wide variety of rheumatic diseases

15 items
o
SIBDQ for patients with Crohn’s disease  

The SIBDQ is a simple, validated, 10 item questionnaire, taken 
from the original 32 question IBDQ, that can be easily scored and 
interpreted by clinicians. 

10 items 
o
DLQI for patients with psoriasis  

Has been used in over 40 different skin conditions 

Most frequently used instrument in studies of randomised 
controlled trials in dermatology. 

10 items 
 
The WHODAS 2.0 will be used to assess the primary endpoint. The WHODAS 2.0 and 
all other questionnaires will be used to assess the secondary endpoints.

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9.5.2
Physician completed assessments
In accordance with the requirements for application for renewal of subsidy by Special 
Authority, a measure of disease activity will be administered within 3–6 months of 
initiation. 
9.6
Study Size
It is anticipated that the three groups will respond differently to adalimumab treatment 
over the study period and there is reason to believe that these groups will be different at 
baseline. Therefore, the sample size will be powered for rheumatoid arthritis and Crohn’s 
disease. Approximately 80 subjects will be enrolled into each of these 2 parallel study 
groups allowing for detection of within participant effect sizes of approximately 0.40 as 
statistically significant (2-WDLOHGĮ ZLWK90% power. A minimum of 30 subjects with 
psoriasis will also be enrolled. A minimum number of 190 patients will be enrolled into 
the study. The maximum number of rheumatoid arthritis and Crohn’s disease patients will 
be N=100 in each arm, respectively.
Psoriasis patients make up a much smaller proportion of the population who currently 
receive adalimumab therapy in New Zealand. Therefore, a smaller number of patients 
(N=30) are sought to be enrolled in this study to ensure the trial population is 
representative of the general patient population. The maximum number of psoriasis 
patients will be N=50.
9.7
Data Management
9.7.1
Data Collection
The Investigator must maintain required records on all study subjects.  Data for this study 
will be recorded in the subject's medical records, study-specific worksheets, CRFs and on 
electronic patient questionnaires provided by Sponsor. All data on the CRFs should be 
recorded with appropriate source documentation.  Upon study completion or at any other 
time specified by the sponsor, a monitor will verify the source documentation records and 
review the data, under the responsibility and authority of the Investigator. The monitor 
will collect the appropriate CRF pages and a complete set of copies will remain at the 
investigational site with any related data clarification forms (DCF).

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9.7.2
Data Correction
Corrections of data entered on original source documents and CRFs must be made in the 
following manner:
x
The incorrect entry must be crossed-out with a single line.  The correct data should 
then be entered next to the entry crossed-out.  Each correction, change or addition 
of new data must be initialed and date by the individual making the correction / 
alteration.
x
Completed source document/CRFs should be ready for review by the Sponsor 
monitor approximately within a week of each study visit for a given subject, 
unless the forms are incomplete because of laboratory data or adverse event 
follow-up that is not yet available.
x
The Sponsor will review the source documents/CRFs, evaluate them for 
completeness and accuracy, and ensure all corrections are made to either the CRF 
or other designated clarification form.
x
Any changes made to the CRF after collection by the Sponsor monitor will be 
discussed and approved by the Investigator (or designee) and corrected on a DCF.
9.7.3
Source Documentation
Investigators must keep accurate separate records (other than the CRFs) of all subjects' 
visits, being sure to include all pertinent study related information.  A statement should be 
made indicating that the subjects have been enrolled in Protocol and have provided 
written Informed Consent.  Any and all side effects and adverse events must be 
thoroughly documented.  Telephone conversations with the subjects concerning the study 
must also be recorded.
The Investigator is responsible for maintaining a Subject Identification Log, which will 
include all subjects who provided informed consent (i.e. to include randomized subjects 
and screening failures). This confidential subject identification code provides the link 
between named subject source records in the subject file and anonymous CRF and 
questionnaire data provided to the sponsor
The Investigator must retain all study related documentation until at least two years after 
at least two years have elapsed since the formal discontinuation of the clinical study.
Study documents should not be destroyed without prior written agreement between the 

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Investigator and the sponsor.  The sponsor must be notified if the Investigator wishes to 
assign the study records to another party, or move them to another location.
9.8
Data Analysis
9.8.1
Definitions
9.8.1.1
Participant Population
All participants who are recruited into the study and start study medication will be used 
for analysis.  A full analysis set will be used for the analysis of the efficacy outcomes with 
all available data used for the analyses of each outcome at the relevant time points. 
Efficacy measures are not assessed after a participant discontinues adalimumab. The 
exception to this will be the analysis of proportion of patients at 6 months who remain on 
adalimumab, having satisfied the requirements for application for renewal of subsidy by 
Special Authority.  Any participants for whom this assessment is not available will be 
assumed to have not met these requirements. The primary population for the evaluation of 
study safety objectives will be the safety population, defined as all participants enrolled 
into the trial who started study medication. Safety outcomes will only be considered while 
the patient is on adalimumab. A standard consort diagram describing participant flow 
(including loss to follow-up and discontinuations for any reason) through the study will be 
generated.
9.8.1.2
Observational Period
The observational period will be from participant enrolment to 6 months or until any 
participant stops study medication or withdraws from the study.
9.8.2
Statistical Analyses
The primary analysis of study efficacy measures will be performed using the full analysis 
set. 

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Tables showing standard descriptive statistics (including means, standard deviations, 
standard errors, medians, ranges and frequencies and percentages), graphs, and participant 
data listings will be used to summarize the baseline demographic and clinical 
characteristics, and the efficacy and safety data at relevant time-points. Tabular and 
graphical summaries will represent data separately for each indication group. 
9.8.3
Demographic and Baseline Characteristics
Participant demographic and baseline clinical characteristics will be summarized 
descriptively by indication group. No hypothesis testing will be performed for these 
summaries.
9.8.4
Primary Efficacy Analyses
The primary efficacy outcome is the change in the total WHODAS 2.0 score at 6 months 
after the initiation of adalimumab, across all indication groups. This change will be 
summarised as the mean and 95% confidence interval and will be tested with a general 
linear model which includes participant, indication and baseline WHODAS 2.0 score as 
terms in the analysis. 
9.8.5
Secondary Efficacy Analyses
The following secondary endpoints will be analysed and summarised using general linear 
models and paired t-tests. The analyses summarising the changes across all indications 
will include participant, baseline levels and indication as terms in the analyses. Those 
analyses analysing changes within indications will use paired t-tests. Mean changes will 
be summarised with 95% confidence intervals derived from these analyses.
x
Change in total WHODAS score 2 and 4 months after the initiation of 
adalimumab across all indications 
x
Change in total WHODAS score 6 months after the initiation of adalimumab 
in each indication
x
Changes in WPAI:GI, K10, Flourishing Scale, and Subject Vitality Scale
scores at 2, 4 and 6 months after the initiation of adalimumab, across all 
indications

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x
Change in disease-specific scores (HAQ-DI, SIBDQ, DLQI) at 2, 4 and 6 
months after the initiation of adalimumab, in each indication
The proportion of patients at 6 months who remain on adalimumab, having satisfied 
the requirements for application for renewal of subsidy by special authority as defined 
below for each indication will be summarised for all indications combined and 
separately. These proportions will be summarised with exact 95% confidence 
intervals. 
x
Rheumatoid arthritis:  GHFUHDVH LQ DFWLYH MRLQW FRXQW IURP EDVHOLQH
AND a clinically significant response to treatment in the opinion of the 
physician
x
Crohn’s disease: &'$,VFRUHUHGXFWLRQE\SRLQWVRU&'$,VFRUH
x
Psoriasis: 3$6,VFRUHUHGXFWLRQRIRULQWKHFDVHRIDSDWLHQWKDGVHYHUH
chronic plaque psoriasis of the face, or palm of a hand or sole of a foot at the 
start of treatment, the patient has a reduction in the PASI symptom subscores 
IRU DOO  RI HU\WKHPD WKLFNQHVV DQG VFDOLQJ WR VOLJKW RU EHWWHU 25 
reduction in affected skin area.
9.8.6
Safety Analyses
Adverse events occurring while participants are on adalimumab will be coded using 
CTCAE classification individually listed by indication groups. The incidences and 
percentages of individuals experiencing AEs and SAEs within each indication will be 
summarized by System Organ Class (SOC) with further summaries by severity and 
relatedness (causality) categories. Adverse events leading to discontinuation and 
concomitant medications will also be listed and summarised.
9.8.7
Additional Analyses
Additional analyses will explore the potential modifying effects of baseline measures on 
the changes in primary and secondary efficacy outcomes. These measures will include 
age, gender, baseline severity, and other diagnoses/co-morbidities. The analyses will 
specifically test for differential changes across the subgroups defined by the potential 
modifiers using general linear models. Further analyses will explore changes in the 

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subscales of some of the efficacy measures, for example the six major life domains of the 
total WHODAS score.
9.9
Missing Data
Efficacy measures are not assessed after a participant discontinues adalimumab. The 
exception to this will be the analysis of proportion of patients at 6 months who remain on 
adalimumab, having satisfied the requirements for application for renewal of subsidy by 
special authority. Any participants for whom this assessment is not available will be 
assumed to have not met these requirements. There will be no other imputation for 
missing data. 
9.10
Interim Analysis
An interim analysis will be conducted at the time point indicated in the study milestones 
section (6.0) on data from all patients who have completed the study up to and including 
the 6 month time-point. This analysis will analyse and summarise the changes in the 
primary and secondary efficacy endpoints and the safety data. The results of this analysis 
will not influence the ongoing conduct of the study.
9.11
Quality Control
Steps to be taken to ensure the accuracy and reliability of data include the selection of 
qualified investigators and appropriate study centres, review of protocol procedures with 
the investigator and associated personnel before the study and periodic monitoring visits 
by the sponsor. Written instructions will be provided for administration and collection of 
study questionnaires. 
Guidelines for CRF completion will be provided and reviewed with study personnel 
before the start of the study. The sponsor will review CRFs and subject questionnaires for 
accuracy and completeness during on-site monitoring visits and after transmission to the 
sponsor; any discrepancies will be resolved with the investigator or designee, as 
appropriate. After upload of the data into the clinical study database they will be verified 
for accuracy and consistency with the data sources.

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9.12
Limitations of the Research Methods
9.13
Other Aspects
9.13.1
Note To File
The Principal Investigator or designee will be responsible for documenting study relevant 
information and occurrences that affects the course of the study.  The information and 
occurrences are not protocol deviations but will be documented in a note to file and will 
be communicated to the sponsor. 
9.13.2
Training Log
All designated study personnel must be trained on the study protocol and procedures.  
Training and retraining are documented on the Training Log.
9.13.3
Visitor Log 
All Sponsor or other related individuals who visit the study site must sign the Visitor Log.  
9.13.4
Responsibilities of the Principal Investigator 
The Principal Investigator is responsible for oversight of enrollment, the patient consent 
process, study related procedures, compliance with the protocol, all institutional, state and 
local guidelines. 
It is the responsibility of the Principal Investigator to select, supervise, and delegate 
responsibility for study conduct to staff members. The Principal Investigator is 
responsible for determining the appropriate staff qualifications required for specific study-
related tasks to be delegated. Study-related tasks delegated to staff members will be 
documented on the Site Signature and Delegation Log.
9.13.5
End of Trial
End of Trial is defined as last subject’s last visit (LPLV). 

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10.0
Protection of Human Subjects
This study must be conducted in compliance with the recommendations of the Declaration 
of Helsinki, 2008 (World Medical Association). In addition, this study will adhere to all 
general and local legal and regulatory requirements applicable to non-interventional 
studies.
Informed consent will be obtained from each subject before the subject can participate in 
the study. The contents and process of obtaining informed consent will be in accordance 
with all applicable regulatory requirements.
As required by applicable local regulations, the sponsor’s Regulatory Affairs group will 
ensure all legal regulatory aspects are covered, and obtain approval of the appropriate 
regulatory bodies, prior to study initiation in regions where an approval is required.
This study is non-interventional and falls outside the scope of the EU Directive 
2001/20/EC, the EU Directive 2005/28/EC and International Conference on 
Harmonization (ICH) Good Clinical Practice (GCP) guidelines. 
This study complies with the EU Directive 95/46/EC of the European Parliament and of 
the Council of 24 October 1995 on the protection of individuals with regard to the 
processing of personal data and on the free movement of such data.
11.0
Management and Reporting of Adverse 
Events/Adverse Reactions
11.1
Adverse Event Definition and Serious Adverse Event 
Categories
An adverse event (AE) is defined as any untoward medical occurrence in a patient, which 
does not necessarily have a causal relationship with their 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 product, 
whether or not the event is considered causally related to the use of the product.
Such an event can result from use of the drug as stipulated in the 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.
An elective surgery/procedure scheduled to occur during the 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

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earlier than planned), then the deterioration of the condition for which the elective
surgery/procedure is being done will be considered an adverse event.
If an adverse event meets any of the following criteria, it is considered a serious adverse 
event (SAE):
Death of Patient:
An event that results in the death of a patient.
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.
Hospitalization:
An event that results in an admission to the hospital 
for any length of time.  This does not include an 
emergency room visit or admission to an outpatient 
facility.
Prolongation of 
Hospitalization:
An event that occurs while the study patient is 
hospitalized and prolongs the patient's hospital stay.
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 
patient.  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 patient and may require medical or 
surgical intervention to prevent any of the outcomes 
listed above (i.e., death of patient, life threatening, 
hospitalization, prolongation of hospitalization, 
congenital anomaly, or persistent or significant 
disability/incapacity).  Additionally, any elective or 

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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.
11.2
Severity
The following definitions will be used to rate the severity for any adverse event being 
collected as an endpoint/data point in the study and for all serious adverse events.
Mild:
The adverse event is transient and easily tolerated by the patient.
Moderate:
The adverse event causes the patient discomfort and interrupts the 
patient's usual activities.
Severe:
The adverse event causes considerable interference with the 
patient's usual activities and may be incapacitating or life 
threatening.
11.3
Relationship to Pharmaceutical Product
The following definitions will be used to assess the relationship of the adverse event to 
the use of product:
Reasonable Possibility
An adverse event where there is evidence to suggest a 
causal relationship between the product and the adverse 
event.
No Reasonable Possibility
An adverse event where there is no evidence to suggest a 
causal relationship between the product and the adverse 
event.
If no reasonable possibility of being related to product is given, an alternate etiology must 
be provided for the adverse event.

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13.0
References
(1)
World Health Organisation. Disability Fact Sheet. Available 
at: http://www.who.int/mediacentre/factsheets/fs352/en/# Accessed 04-DEC-2014.
(2)
World Health Organisation 2011. World Report On Disability. Available 
at: http://www.who.int. Accessed 04-DEC-2014.
(3)
Scott DL, et al. Lancet 2010 Sep 25;376(9746):1094-108
(4)
Kalla R, et al. BMJ 2014 Nov 19;349:g6670. doi: 10.1136/bmj.g6670
(5)
Griffiths C, et al. Lancet 2007;370, Issue 9583, 21–27 July 2007:263-271
(6)
AbbVie Limited. Humira Data Sheet. 27 November 2014, Version 32. Available 
at www.medsafe.govt.nz Accessed 04-DEC-2014
(7)
World Health Organisation. (2010). World Health Organization Disability 
Asessment Schedule 2.0. Retrieved 
from http://www.who.int/classifications/icf/WHODAS2.0_12itemsINTERVIEW.p
df
(8)
Reilly, M. C., et al. Pharmacoeconomics, 1993;4(5):353-365.
(9)
Kessler R.C., et al. Archives General Psychiatry 2003;60(2):184-189.
(10) Diener E., Biswas-Diener R. (2009), Flourishing Scale. Retrieved 
from http://internal.psychology.illinois.edu/~ediener/Documents/FS.pdf
(11) Ryan, R. M., & Frederick, C. M. Journal of Personality 1997;65;529-565.
(12) Fries, J. F., et al. Arthritis & Rheumatism 1980;23(2):137-145.
(13) Irvine, E.J., et al. American Journal of Gastroenterology 1996;91(8):1571.
(14) Finlay, A.Y., Khan, G.K. Clinical and  Experimental Dermatology 1994;19:210–
216.

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Annex 1.
Study Questionnaires
A.
WHODAS 2.0 questionnaire 12-item version, self-administered
The World Health Organization Disability Assessment Schedule (WHODAS 2.0) is a 
generic assessment instrument developed to provide a standardized method for measuring 
health and disability across cultures. It was developed from a comprehensive set of 
International Classification of Functioning, Disability and Health (ICF) items that are 
sufficiently reliable and sensitive to measure the difference made by a given intervention. 
This is achieved by assessing the same individual before and after the intervention.
WHODAS 2.0 has been found to be useful for assessing health and disability levels in the 
general population through surveys and for measuring the clinical effectiveness and 
productivity gains from interventions.
WHODAS 2.0 captures the level of functioning in six domains of life:
• Domain 1: Cognition – understanding and communicating
• Domain 2: Mobility – moving and getting around
• Domain 3: Self-care – attending to one’s hygiene, dressing, eating and staying alone
• Domain 4: Getting along – interacting with other people
• Domain 5: Life activities – domestic responsibilities, leisure, work and school
• Domain 6: Participation – joining in community activities, participating in society.
For all six domains, WHODAS 2.0 provides a profile and a summary measure of 
functioning and disability that is reliable and applicable across cultures, in all adult 
populations.
WHODAS 2.0 provides a common metric of the impact of any health condition in terms 
of functioning. Being a generic measure, the instrument does not target a specific disease 
– it can thus be used to compare disability due to different diseases. WHODAS 2.0 also 
makes it possible to design and monitor the impact of health and health-related 
interventions. The instrument has proven useful for assessing health and disability levels 
in the general population and in specific groups (e.g. people with a range of different 
mental and physical conditions). 
Aspects that make WHODAS 2.0 particularly useful are its sound theoretical 
underpinnings, good psychometric properties, numerous applications in different groups 
and settings, and ease of use. WHODAS 2.0 can be self-administered in around 5 minutes, 

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and administered through an interview in 20 minutes. The instrument is easy to score and 
interpret (Ustun, Kostanjsek, Chatterji, & Rehm, 2010).

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© 2010 World Health Organisation

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B. Kessler Psychological Distress Scale (K10)
This is a 10-item questionnaire intended to yield a global measure of distress based on 
questions about anxiety and depressive symptoms that a person has experienced in the 
most recent 4 week period.
© 2003 RC Kessler

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C. Health Assessment Questionnaire–Disability Index (HAQ-DI)

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© 1980 JF Fries

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C. Short Quality of Life in Inflammatory Bowel Disease Questionnaire (IBDQ)
This questionnaire is designed to find out how you have been feeling during the last 2 
weeks. You will be asked about symptoms you have been having as a result of your 
inflammatory bowel disease, the way you have been feeling in general, and how your 
mood has been. Please circle the number of your choice below each question.
1. How often has the feeling of fatigue or being tired and worn out been a problem for you 
during the past 2 weeks?
1. All of the time
2. Most of the time
3. A good bit of the time
4. Some of the time
5. A little of the time
6. Hardly any of the time
7. None of the time
2. How often during the last 2 weeks have you delayed or canceled a social engagement 
because of your bowel problem?
1. All of the time
2. Most of the time
3. A good bit of the time
4. Some of the time
5. A little of the time
6. Hardly any of the time
7. None of the time
3. As a result of your bowel problems, how much difficulty did you experience doing 
leisure or sports activities you would have liked to have done during the past 2 weeks?
1. A great deal of difficulty; activities made impossible
2. A lot of difficulty
3. A fair bit of difficulty
4. Some difficulty
5. A little difficulty
6. Hardly any difficulty
7. No difficulty; the bowel problem did not limit sports or leisure activities
4. How often during the past 2 weeks have you been troubled by pain in the abdomen?
1. All of the time
2. Most of the time
3. A good bit of the time
4. Some of the time
5. A little of the time

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6. Hardly any of the time
7. None of the time
5. How often during the past 2 weeks have you felt depressed or discouraged?
1. All of the time
2. Most of the time
3. A good bit of the time
4. Some of the time
5. A little of the time
6. Hardly any of the time
7. None of the time
6. Overall, in the past 2 weeks, how much of a problem have you had with passing large 
amounts of gas?
1. A major problem
2. A big problem
3. A significant problem
4. Some problem
5. A little trouble
6. Hardly any trouble
7. No trouble
7. Overall, in the past 2 weeks, how much of a problem have you had maintaining or 
getting to the weight you would like to be?
1. A major problem
2. A big problem
3. A significant problem
4. Some problem
5. A little trouble
6. Hardly any trouble
7. No trouble
8. How often during the past 2 weeks have you felt relaxed and free of tension?
1. All of the time
2. Most of the time
3. A good bit of the time
4. Some of the time
5. A little of the time
6. Hardly any of the time
7. None of the time
9. How much of the time during the past 2 weeks have you been troubled by a feeling of 
having to go to the bathroom even though your bowels were empty?
1. All of the time
2. Most of the time

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3. A good bit of the time
4. Some of the time
5. A little of the time
6. Hardly any of the time
7. None of the time
10. How often during the past 2 weeks have you felt angry as a result of your bowel 
problem?
1. All of the time
2. Most of the time
3. A good bit of the time
4. Some of the time
5. A little of the time
6. Hardly any of the time
7. None of the time
© 1996 EJ Irvine

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D. Dermatology Life Quality Index
© 1994 AY Finlay

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E. Work Productivity and Activity Impairment Questionnaire: General Health 
V2.0 (WPAI:GH)
The following questions ask about the effect of your health problems on your ability to 
work and perform regular activities.  By health problems we mean any physical or 
emotional problem or symptom. Please fill in the blanks or circle a number, as 
indicated.
1.      Are you currently employed (working for pay)?    _____NO       
YES
If NO, check "NO" and skip to question 6.
The next questions are about the past seven days, not including today.
2.
During the past seven days, how many hours did you miss from work because 
of your health problems? Include hours you missed on sick days, times you went in 
late, left early, etc., because of your health problems. Do not include time you 
missed to participate in this study.
HOURS
3.
During the past seven days, how many hours did you miss from work because of 
any other reason, such as vacation, holidays, time off to participate in this study?
HOURS
4.      During the past seven days, how many hours did you actually work?
HOURS (If "0," skip to question 6.)
5. During the past seven days, how much did your health problems affect your
productivity while you were working?
Think about days you were limited in the amount or kind of work you could do, days you
accomplished less than you would like, or days you could not do your work as carefully
as usual. If health problems affected your work only a little, choose a low number.
Choose a high number if health problems affected your work a great deal.

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6. During the past seven days, how much did your health problems affect your ability
to do your regular daily activities, other than work at a job?
By regular activities, we mean the usual activities you do, such as work around the
house, shopping, childcare, exercising, studying, etc. Think about times you were limited
in the amount or kind of activities you could do and times you accomplished less than you
would like. If health problems affected your activities only a little, choose a low number.
Choose a high number if health problems affected your activities a great deal.
© 1993 MC Reilly

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F. Flourishing Scale
The Flourishing Scale consists of eight items describing important aspects of human 
functioning ranging from positive relationships, to feelings of competence, to having 
meaning and purpose in life. The scale was called Psychological Well-being in an earlier 
publication, but the name was changed to more accurately reflect the content because the 
scale includes content that goes beyond psychological well-being narrowly defined.
© 2009 E Diener

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G. Subjective Vitality Scale
The concept of subjective vitality refers to the state of feeling alive and alert - to having 
energy available to the self.
© 1997 RM Ryan

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Annex 2.
Protocol Amendment: List of Changes
The summary of changes is listed in Section 1.1.
Specific Protocol Changes:
Title Page
Protocol title previously read: 
An Observational Study of the Effectiveness of Adalimumab on Health and Disability 
Outcomes in New Zealand Patients with Immune-Mediated Inflammatory Diseases
Has been changed to read:
An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability 
Outcomes in New Zealand Patients with Immune-Mediated InflammaTorY Diseases
(VITALITY)
Section 3.0 Responsible Parties
Study-Designated Physician
Landline phone number has been deleted as it no longer exists.
Email address specified.
Section 4.0 Abstract
Subsection: Title
Previously read: 
An Observational Study of the Effectiveness of Adalimumab on Health and Disability 
Outcomes in New Zealand Patients with Immune-Mediated Inflammatory Diseases
Has been changed to read:
An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability 
Outcomes in New Zealand Patients with Immune-Mediated InflammaTorY Diseases
(VITALITY)
Section 4.0 Abstract
Subsection: Inclusion Criteria
Addition of text:

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Patients have been evaluated for tuberculosis risk factors/exposure for active/latent 
tuberculosis infection (per local requirements and according to the approved 
adalimumab New Zealand Datasheet).
Section 6.0 Milestones
Previously read:
Major study milestones and their planned dates are as follows:
Start of Data Collection (FPFV):
13 April 2015
End of Data Collection:
12 April 2016
Database Lock:
26 April 2016
Interim Database Lock:
01 December 2015
Interim Report:
01 February 2016
Final Report of Study Results:
07 June 2016
Has been changed to read:
Major study milestones and their planned dates are as follows:
Start of Data Collection (FPFV):
06 July 2015
End of Data Collection:
06 September 2016
Database Lock:
20 September 2016
Interim Database Lock:
01 March 2016
Interim Report:
31 March 2016
Final Report of Study Results:
11 November 2016
Section 9.0 Research Methods
Subsection 9.1 Study Design, Paragraph 3
Addition of text:
AbbVie is not supplying adalimumab; adalimumab is to be used according to the 
approved adalimumab New Zealand Datasheet and is to be prescribed by the physician 
under usual and customary practice of physician prescription.
Section 9.0 Research Methods
Subsection 9.1 Study Design, Paragraph 8

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Previously read:
No restriction on current standard of care is imposed. The use of any concomitant
medication and any and all adverse events will be captured and recorded in the CRF. 
Has been changed to read:
No restriction on current standard of care is imposed. Physicians should treat their patients 
as they would in their routine clinical practice. Prior medical history, the use of any 
concomitant medication and any and all adverse events will be captured and recorded in 
the CRF. 
Section 9.0 Research Methods
Subsection 9.1 Study Design, Following Paragraph 9
Addition of text:
Prior to collecting any study related information, written informed consent must be 
obtained.
Each subject has the right to withdraw from the study at any time.  In addition, the 
investigator may discontinue a subject from the study at any time if the investigator 
considers it necessary for any reason, including the occurrence of an adverse event or 
noncompliance with the protocol.  
In the event that a subject withdraws or is discontinued from the study, the primary reason 
for discontinuation and any other reason(s) for the discontinuation from the study will be 
recorded. If the reason for treatment discontinuation is due to a serious adverse event, it 
should be reported to AbbVie within 24 hours of physician's awareness.
Subjects will be withdrawn from the study immediately if any of the following occur:
x
The investigator believes it is in the best interest of the subject.
x
The subject or subject's guardian requests withdrawal from the study.
x
A selection criteria violation was noted after the subject started adalimumab.
The study procedures to be conducted (if part of routine clinical practice) are outlined in 
the schematic presented in Table 1
Section 9.0 Research Methods
Subsection 9.1.1 Schedule of Events

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Addition: Row titled “Demographics” to table.
Addition: Footnote for “Demographics”: 
† Once the physician has determined that the patient is eligible for inclusion, and the patient has agreed to 
be included in the observational study, the patient's demographic data (including year of birth, gender, 
ethnicity) will be recorded on the CRFs at the Baseline visit
Addition: Footnote for “Medical History”: 
*The physician will determine the patient's current health status and obtain a complete medical history 
including history of tobacco, date of diagnosis, disease activity, concomitant medications and TB 
exposure/risk factors at the Baseline visit.
TB events previously read:
Have record of a Purified Protein Derivative (PPD) test or Quantiferon Gold Test and a Chest X-Rayb
Has been changed to read:
TB History assessment
Addition: Footnote for “TB History assessment”: 
An assessment of TB exposure/risk factors for active and latent TB (per local requirements and according to 
the approved adalimumab NZ Datasheet) must have been completed prior to the first dose of adalimumab 
with documented history of results
Addition: Footnote for “CRP”: 
CRP will only be collected if procedure is performed as part of the usual standard of care
Section 9.0 Research Methods
Addition of Subsection 9.1.3 Physician’s assessment of disease activity: Active joint 
count, or CDAI, or PASI 
An assessment of disease activity by the Physician will be recorded at the Baseline Visit 
and within 3–6 months of initiation, as per standard of care.
Addition of Subsection 9.1.3 PRO Questionnaires
Patients will complete the following questionnaires at the visits identified on the Study 
Activities Table (Table 1). 
•
WHODAS 2.0 
•
WPAI:GH V2.0
•
K10

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•
Flourishing Scale
•
Subject Vitality Scale
•
A Disease-Specific patient reported outcome questionnaire:
o
HAQ-DI for patients with rheumatoid arthritis 
o
SIBDQ for patients with Crohn’s disease 
o
DLQI for patients with psoriasis 
At the Baseline visit, the questionnaires must be completed before the first dose of 
adalimumab.
Addition of Subsection 9.1.4 Adalimumab dosing
The participating Physician will provide the patient with a prescription for adalimumab, 
along with instructions for appropriate use. The date of first dose of adalimumab will be 
recorded in the CRF and should closely align with the Baseline visit, but not before 
completion of the PRO questionnaires.  
Addition of Subsection 9.1.5 Product Supply
Adalimumab will be obtained as commercially available medication. AbbVie will not 
provide the medication for this study.
Section 9.2 Setting
Paragraph 5
Addition of text:
AbbVie is not supplying adalimumab; adalimumab is to be used according to the 
approved adalimumab New Zealand Datasheet and is to be prescribed by the physician 
under usual and customary practice of physician prescription.
Section 9.2 Setting
Subsection 9.2.1 Inclusion Criteria:
Addition of text:

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Patients who have been evaluated for tuberculosis risk factors/exposure for 
active/latent tuberculosis infection (per local requirements and according to the 
approved adalimumab New Zealand Datasheet).
Addition of Subsection 9.2.3 Discontinuation of Individual Subjects: 
Each subject has the right to withdraw from the study at any time.  In addition, the 
investigator may discontinue a subject from the study at any time if the investigator 
considers it necessary for any reason, including the occurrence of an adverse event.  If the 
reason for treatment discontinuation is due to a serious adverse event, it should be 
reported to AbbVie within 24 hours of physician's awareness. 
In the event that a subject withdraws or is discontinued from the study, the primary reason 
for discontinuation and any other reason(s) for the discontinuation from the study will be 
recorded. Following discontinuation of the study drug, the patient will be treated in 
accordance with the Investigator's best clinical judgment.
For subjects who discontinue from the study prematurely a phone call will be made 30 
days after the last dose of adalimumab is administered to obtain follow-up information on 
any ongoing or new adverse events.
Subjects will be withdrawn from the study immediately if any of the following occur:
x
The investigator believes it is in the best interest of the subject.
x
The subject or subject's guardian requests withdrawal from the study.
x
A selection criteria violation was noted after the subject started study drug.
Section 9.5 Data Sources
Previously read:
Designated investigator staff will collect data required by the protocol on paper Case 
Report Forms (CRFs). Collection of data includes but not limited to subject 
demographics, adverse events, serious adverse events and concomitant medications. 
Designated investigator staff should not enter any data until they have completed 
appropriate training. These paper CRFs will be photocopied by the Sponsor or Sponsor 
Representative (CRA) and brought back for the Data Manager to enter into the database. 

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Where there are discrepancies with the data, data clarification forms should be raised for 
the designated investigator staff to clarify and return to the Sponsor
Has been changed to read:
Designated investigator staff will collect data required by the protocol on paper Case 
Report Forms (CRFs). Collection of data includes but not limited to subject 
demographics, adverse events, serious adverse events and concomitant medications. 
Designated investigator staff should not enter any data until they have completed 
appropriate training. The sites are requested to send a copy of the CRF (scanned copy is 
acceptable) through to the Data Manager to enter into the database within 10 working 
days. Where there are discrepancies with the data, data clarification forms should be 
raised for the designated investigator staff to clarify and return to the Sponsor.
Section 9.5.1 Questionnaires
Paragraph 1
Previously read:
Subject self-assessment questionnaires will be utilized in this study to determine patients’ 
improvement over time. Patients will require Internet access as the questionnaires are 
administered electronically through an online portal. For patients unable to utilize the 
online questionnaires paper-and-pencil versions of questionnaires will be provided and 
can be self-administered in person in a quiet and private area of the clinic. In addition, for 
subjects completing paper and pencil versions, the questionnaires can be administered 
over the telephone if the questionnaire time-point does not coincide with a clinic visit. 
Data collected via paper and pencil versions of the questionnaires will be transcribed by 
site staff into the online portal on behalf of the patient. Data will be retrieved directly by 
the Data Manager for analysis. Based on a pilot evaluation of the study questionnaires in a 
small number of patients, they are expected to take approximately 10 minutes per visit, 
per subject, to administer.
Has been changed to read:
Subject self-assessment questionnaires will be utilized in this study to determine patients’ 
improvement over time. Patients will require Internet access as the questionnaires are 
administered electronically through an online portal. For patients unable to utilize the 
online questionnaires paper-and-pencil versions of questionnaires will be provided and 
can be self-administered in person in a quiet and private area of the clinic. In addition, for 
subjects completing paper and pencil versions, the questionnaires can be administered 
over the telephone if the questionnaire time-point does not coincide with a clinic visit. 
Data collected via paper and pencil versions of the questionnaires will be transcribed by 
site staff into the online portal on behalf of the patient. Data will be retrieved directly by 

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the Data Manager for analysis. Based on a pilot evaluation of the study questionnaires in a 
small number of patients, they are expected to take approximately 10 minutes per visit, 
per subject, to administer. Patients should ensure that their subject number and the date  
the questionnaire was completed is entered onto the questionnaire.
Section 11.0 Management and Reporting of Adverse Events/Adverse Reactions
Subsection 11.1 Adverse Event Definition and Serious Adverse Event Categories
Insertion of new paragraph direcly following Paragraph 1:
An elective surgery/procedure scheduled to occur during the 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.
Section 11.0 Management and Reporting of Adverse Events/Adverse Reactions
Subsection 11.5 Serious Adverse Event Reporting
Previously read:
In the event of a serious adverse event, the physician will:
Ɣ
For events from patients using and AbbVie product - notify the AbbVie
Emergency contact person identified below within 24 hours of the physician 
becoming aware of the event.
Has been changed to read:
In the event of a serious adverse event, and additionally, any non-serious event of malignancy 
in patients 30 years of age and younger, whether related to study drug or not, the Investigator 
will notify AbbVie Drug Safety (email drugsafetyanz@abbvie.com (preferred), fax: +61
2 6100 9780, or Ph: +61 2 9035 8640) within 24 hours of the site being aware of the event.
Section 11.0 Management and Reporting of Adverse Events/Adverse Reactions
Subsection 11.6 Pregnancy reporting
Previously read: