PERSIST: PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS PERSISTENCE OF CT-P13 (INFLIXIMAB) IN PATIENTS WITH RHEUMATOID DISEASES WHO ARE EITHER NAIVE TO BIOLOGICS OR SWITCHED FROM STABLE REMICADE(R) (INFLIXIMAB)
Conditions: Rheumatoid Diseases, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Sponsor: Pfizer

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NON-INTERVENTIONAL (NI) STUDY PROTOCOL 
Study information 
Title 
PERSIST: Prospective ObsErvational CohoRt Study to 
Assess Persistence of CT-P13™ (Infliximab) in patients 
with Rheumatoid Diseases who are either Naive to 
biologics or Switched from sTable Remicade® 
(infliximab) 
Protocol number 
C1231002 
Protocol version identifier 
Version 2.0 
Date of last version of protocol 
17 May 2017 
Active substance 
Infliximab 
Medicinal product 
CT-P13™ (infliximab), Remicade® (infliximab) 
Research question and 
objectives 
Primary study objectives: 
• To evaluate real-life drug persistence in rheumatoid 
arthritis (RA), ankylosing spondylitis (AS), and 
psoriatic arthritis (PsA) patients who are either 
initiated with CT-P13™ as their first biologic, or 
who are switched from stable Remicade® 
• To characterise the patient populations and drug 
utilization patterns of RA, AS, and PsA patients 
who are either initiated with CT-P13CT-P13™ as 
their first biologic, or who are switched from stable 
Remicade® 
• To assess the safety of CT-P13™ in RA, AS, and 
PsA patients who are either initiated with CT-P13™ 
as their first biologic, or who are switched from 
stable Remicade® for up to 2 years including: 
• Serious adverse events (SAE); 
• Adverse events of special interest (AESI); 
• Adverse events (AE). 
Secondary study objectives: 

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x To assess effectiveness of CT-P13™ in the 
treatment of patients with RA, AS, or PsA as 
measured by the Disease Activity Score (DAS28) in 
RA and PsA patients, Ankylosing Spondylitis 
Disease Activity Score (ASDAS), Bath Ankylosing 
Spondylitis Disease Activity Index (BASDAI) and 
Bath Ankylosing Spondylitis Functional Index 
(BASFI) in AS patients over the study period 
x To assess Patients reported Outcomes as measured 
by the Health Assessment Questionnaire Disability 
Index (HAQ-DI), Short Form 12-version 2 
(SF-12v2) and EuroQol 5-dimensions 3-levels 
(EQ-5D-3L) for all patients over the study period 
x To assess the Physician Global Assessment (PGA) 
over the study period  
Author 
 
 
Pfizer Inc.  
 
PPD
PPD

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TABLE OF CONTENTS 
LIST OF TABLES .....................................................................................................................5 
APPENDICES ...........................................................................................................................5 
1. LIST OF ABBREVIATIONS ................................................................................................6 
2. RESPONSIBLE PARTIES ....................................................................................................7 
3. ABSTRACT ...........................................................................................................................8 
4. AMENDMENTS AND UPDATES .....................................................................................12 
5. MILESTONES .....................................................................................................................13 
6. RATIONALE AND BACKGROUND ................................................................................13 
7. RESEARCH QUESTION AND OBJECTIVES .................................................................15 
7.1. Primary Study Objectives ........................................................................................15 
7.2. Secondary Study Objectives ....................................................................................15 
8. RESEARCH METHODS ....................................................................................................16 
8.1. Study Design ...........................................................................................................16 
8.2. Setting ......................................................................................................................16 
8.2.1. Regions/Number of Study Sites ..................................................................16 
8.2.2. Enrolment ...................................................................................................17 
8.2.3. Patient Eligibility ........................................................................................17 
8.2.3.1. Inclusion Criteria .......................................................................17 
8.2.3.2. Exclusion Criteria ......................................................................17 
8.3. Study Variables .......................................................................................................17 
8.3.1. Minimum data set (variables to be collected) .............................................17 
8.3.2. Patient Reported Outcomes for assessment of Health Related Quality 
of Life: .............................................................................................................19 
8.3.3. Data Sources ...............................................................................................20 
8.4. Study Size ................................................................................................................24 
8.5. Data Management ...................................................................................................24 
8.5.1. Electronic Data Capture System .................................................................24 
8.5.2. Data Entry ...................................................................................................24 
8.5.3. Statistical Software .....................................................................................24 
8.6. Data Analysis ..........................................................................................................24 
8.6.1. Demographic and Baseline Characteristics ................................................25 
8.6.2. Study Drug Utilization ................................................................................25 

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8.6.3. Real-life Drug Persistence ..........................................................................25 
8.6.4. Safety Variables ..........................................................................................25 
8.6.4.1. Adverse Events ..........................................................................26 
8.6.4.2. Adverse Events of Special Interest ............................................26 
8.6.4.3. Serious Adverse Events .............................................................26 
8.6.5. Effectiveness ...............................................................................................26 
8.6.6. Patient Reported Outcomes ........................................................................26 
8.6.6.1. Health Related Quality of Life ..................................................26 
8.6.6.2. EuroQoL 5-dimensions 3-levels ................................................27 
8.6.6.3. Patient’s General Health Assessment ........................................27 
8.6.7. Physician’s Global Assessment ..................................................................27 
8.7. Quality Control and Quality Assurance ..................................................................27 
8.7.1. Site Training and Initiation .........................................................................27 
8.7.2. Site Monitoring ...........................................................................................27 
8.8. Limitations of the Research Methods ......................................................................28 
8.8.1. Lost to Follow-up .......................................................................................28 
8.8.2. Study Limitations........................................................................................28 
8.9. Other Aspects ..........................................................................................................29 
8.9.1. National Leaders Committee ......................................................................29 
8.9.2. Concomitant Medication Use .....................................................................29 
8.9.3. Regulatory Authorities................................................................................30 
8.9.4. Protocol Modifications ...............................................................................30 
8.9.5. Compensation to Investigators ...................................................................30 
9. PROTECTION OF HUMAN SUBJECTS ..........................................................................30 
9.1. Patient Information and Consent .............................................................................30 
9.2. Patient withdrawal ...................................................................................................30 
9.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ..............31 
9.4. Ethical Conduct of the Study ..................................................................................31 
10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS ......................................................................................................................32 
10.1. Single reference safety document .........................................................................41 
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS........41 
11.1. Reporting to Regulatory Agencies ........................................................................41 

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11.2. Use of Information and Publications .....................................................................41 
12. REFERENCES ..................................................................................................................43 
13. LIST OF TABLES .............................................................................................................45 
14. LIST OF FIGURES ...........................................................................................................45 
 
LIST OF TABLES 
Table 1. 
Study Data Collection Schedule ...........................................................................21 
 
APPENDICES 
Appendix 1. ANNEX 1. LIST OF STAND ALONE DOCUMENTS ....................................46 
Appendix 2. ANNEX 2. HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY 
INDEX ..................................................................................................................47 
Appendix 3. ANNEX 3. PHYSICIAN GLOBAL ASSESSMENT OF DISEASE 
ACTIVITY ...........................................................................................................51 
Appendix 4. ANNEX 4. EQ-5D-3L ........................................................................................52 
Appendix 5. ANNEX 5 SF-12v2 .............................................................................................56 
Appendix 6. ANNEX 6. STUDY COUNTRIES AND LANGUAGES ..................................60 
Appendix 7. ANNEX 7. DISEASE ACTIVITY SCORE IN 28 JOINTS ...............................61 
Appendix 8. ANNEX 8. BATH ANKYLOSING SPONDYLITIS FUNCTIONAL 
INDEX ..................................................................................................................62 
Appendix 9. ANNEX 9. BATH ANKYLOSING SPONDYLITIS DISEASE 
ACTIVITY INDEX ..............................................................................................63 
Appendix 10. ANNEX 10. ANKYLOSING SPONDYLITIS DISEASE ACTIVITY 
SCORE .................................................................................................................64 

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1. LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
ADR 
adverse drug reaction 
AE 
adverse event 
AEM 
Adverse event monitoring 
AESI 
adverse events of special interest  
AS 
ankylosing spondylitis  
ASDAS 
Ankylosing Spondylitis Disease Activity Score 
ATI 
antibody to infliximab 
BASDAI 
Bath Ankylosing Spondylosis Disease Activity Index 
BASFI 
Bath Ankylosing Spondylitis Functional Index 
BCG 
Bacillus Calmette–Guérin vaccine 
BDMARD 
biologic disease modifying anti rheumatic drugs 
BMI 
body mass index 
CRF 
case report form  
DAS 
Disease Activity Score 
DMARD 
disease-modifying antirheumatic drugs  
EDC 
electronic data capture 
EDP 
Exposure during pregnancy  
EMA 
European Medicines Agency  
EQ-5D-3L 
EuroQol 5-dimensions 3-levels 
EU 
European Union 
FSFV 
First Subject First Visit 
HAQ-DI 
Health Assessment Questionnaire-Disability Index 
HBV 
Hepatitis B virus 
HRQoL 
Health Related Quality of Life 
HSTCL 
Hepatosplenic T-cell lymphoma 
ICF 
informed consent form 
ID 
identification number 
IEC 
independent ethics committee 
IgG 
Immunoglobulin G 
IRB 
institutional review board 
LSLV 
Last Subject Last Visit 
mAb 
monoclonal antibody 
MCS 
Mental Component Summary 
MedDRA 
Medical Dictionary for Regulatory Activities 
NIS 
non-interventional study 
PCS 
Physical Component Summary 
PGA 
Physician Global Assessment 
PI 
Principal Investigator  
PRO 
Patient Reported Outcome 
PsA 
psoriatic arthritis  
RA 
rheumatoid arthritis  
SAE 
serious adverse events  
SAP 
statistical analysis plan 
SAS 
statistical analysis software 
SD 
standard deviation 
SJC 
swollen joint count 
SF-12v2 
Short Form-12 version 2 
SmPC 
Summary of Product Characteristics 
SRSD 
single reference safety document 
TJC 
tender joint count 
TNF 
tumor necrosis factor 
VAS 
Visual Analogue Scale 
WIC 
Written Informed Consent 

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2. RESPONSIBLE PARTIES 
Principal Investigator(s) of the Protocol 
The table below includes the list of National Leaders for the participating countries.  
Name, degree(s) 
Title 
Affiliation 
Address 
 
Professor 
 
 
 Bulgaria 
 
Professor 
 
 
 
 France 
 
 
Professor 
 
 
 
 
 
, Germany 
 
 
Professor, PHD 
 
 
 Greece 
 
Professor 
 
 
 
 Italy 
 
 
Professor 
 
   
 
 Spain 
 
 
 
Professor 
 
 
 
 
 UK 
 
Physician 
 
 
 Canada 
 
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PPD
PP
D

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3. ABSTRACT 
Protocol Title 
Prospective ObsErvational CohoRt Study to Assess Persistence of CT-P13™ (infliximab) in 
patients with Rheumatoid Diseases who are either Naive to biologics or Switched from 
sTable Remicade® (infliximab). 
Rationale and Background 
Rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) are 
inflammatory conditions that typically cause chronic arthritis with variable localization.1  
Timely use of disease-modifying antirheumatic drugs (DMARDs) is an essential aspect of 
disease management, but many patients may not respond even when conventional agents are 
used optimally.2  Widespread use of biologic disease modifying anti rheumatic drugs 
(BDMARDs), including anti tumor necrosis factor (TNF) agents, has revolutionized the 
treatment of these disease entities as evident by a number of randomized controlled trials in 
each of these indications.3,4  Remicade® (infliximab, Janssen Biologics B.V.), an IgG1 
(Immunoglobulin G) chimeric human-murine monoclonal antibody (mAb), was approved in 
Europe in August 1999 and has been widely used in the treatment of RA, AS, and PsA.5 
In September 2013, CT-P13™ (infliximab), a biosimilar to the reference product Remicade® 
(infliximab), was approved by the European Medicines Agency (EMA) based on an 
extensive non clinical and clinical comparability exercise between these two versions of 
infliximab.  This rigorous comparison demonstrated similar quality, pharmacokinetics, 
efficacy, and safety between CT-P13™ and Remicade®.  Marketing authorization of 
CT-P13™ in the European Union (EU) includes all approved indications of Remicade® 
including RA, AS and PsA; Health Canada approved CT-P13™ for RA, AS, PsA, and plaque 
psoriasis in January of 2014.6,7 
Consistent with the basic premise of biosimilars, CT-P13™ is expected to provide similar 
quality, efficacy, and safety as Remicade®.  On this basis it can be expected that CT-P13™ 
will be considered in varied settings in RA, AS, and PsA patients including BDMARDs 
naive patients, and as an alternative in stable patients receiving Remicade®.  
This prospective observational study has therefore been designed to characterize biologic 
naive RA, AS, and PsA patients receiving CT-P13™ or those switched to CT-P13™ from 
stable treatment with Remicade®™. 
Research Objective 
Primary study objectives: 
• To evaluate real-life drug persistence* in RA, AS, and PsA patients who are either 
initiated with CT-P13™ as their first biologic, or who are switched from stable 
Remicade®; 

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• To characterise the populations and drug utilization patterns of RA, AS, and PsA 
patients who are either initiated with CT-P13™ as their first biologic, or who are 
switched from stable Remicade®. 
• To assess the safety of CT-P13™ in RA, AS, and PsA patients who are either 
initiated with CT-P13™ as their first biologic, or who are switched from stable 
Remicade® for up to 2 years including: 
• Serious adverse events (SAE); 
• Adverse events of special interest (AESI); 
• Adverse events (AE). 
*Real-life drug persistence has been suggested as a simple, practically relevant, indirect 
approach for assessing long-term therapeutic benefit and potential harm.  This suggestion is 
based on the assumption that when using a drug that reduces symptoms and prevents 
complications, patients persist with the treatment as long as they experience or perceive a 
benefit and they do not experience (or perceive) an unacceptable amount of harm.  At 
present, a cure for RA, AS, and PsA is not available, long-term anti-inflammatory treatment 
guided by clinical activity defines current state of the art treatment options.  Persistence, as 
one outcome of the study, is defined as a continuous variable to be measured in time from 
index until drug discontinuation. 
Secondary study objectives:  
• To assess effectiveness of CT-P13™ in the treatment of patients with RA, AS, or PsA 
as measured by:  
• the Disease Activity Score (DAS28) in RA and PsA patients, Ankylosing 
Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis 
Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional 
Index for AS patients (BASFI) in AS patients over the study period; 
• To assess Patients reported Outcomes as measured by:  
• the Health Assessment Questionnaire Disability Index (HAQ-DI) for all patients;  
• the Short Form 12-version 2 (SF-12v2) for all patients); 
• the EuroQol 5-dimensions 3-levels for all patients over the study period; 
• To assess the Physician Global Assessment (PGA) over the study period.  

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Study Design 
This is a multi-national, prospective, observational study of RA, AS, and PsA patients 
enrolled after having already been deemed suitable by their physicians for treatment with 
CT-P13™, either as BDMARD naive or after a switch from stable treatment with 
Remicade®.  The study will not interfere with the usual care of patients, and neither study 
visits nor specific diagnostic interventions will be mandated.  
The decision to initiate treatment with CT-P13™ or to switch from stable treatment with 
Remicade® to CT-P13™, as well as the decision to enrol a particular patient in the study will 
be the physician´s responsibility and according to the prescribing recommendation in the 
particular country.  Only patients meeting all eligibility criteria may be invited to enrol in the 
study.  For each eligible patient, informed consent must be obtained prior to any study related 
activities. 
In order to meaningfully characterize the RA, AS, and PsA populations and drug utilization 
patterns associated with the use of CT-P13™, as well as its safety and effectiveness, the 
study plans to enrol approximately 1500 patients in a mix of academic and community sites 
in approximately 9 countries in Europe and Canada.  
All patients are expected to be enrolled over an approximate 16 month period, with each 
patient followed for up to 2 years. However, after 18 months of enrolment, enrolment for the 
study ended on 31st of December 2016 for futility when 351 patients had been enrolled.  
Enrolled patients who permanently discontinue infliximab (CT-P13™ or Remicade®) 
treatment will be encouraged to remain in the study and be followed for the remainder of the 
study period using a simplified case report form (CRF).  Due to the nature of the observation 
study, there will be no study visits mandated per the study protocol.  Patients’ visit schedules 
will follow local standard of care typically coinciding with the schedule of infusions of 
CT-P13™, with additional visits as needed at the treating physician’s discretion. Data for the 
study will be entered into an electronic data capture (EDC) system at enrolment and then 
approximately every 2-6 months thereafter up to 2 years.  Additional data captured will 
include demographics, drug utilization patterns, safety, clinical outcomes, and patient 
reported outcomes (PROs). 
Population 
The target study population will include biologic naive RA, AS, and PsA patients receiving 
CT-P13™ or those switched to CT-P13™ from stable treatment with Remicade®. 
The study variables to be collected include patient demographics, all clinically relevant (RA, 
AS, and PsA) medical history and prior treatment data, clinical assessment of disease 
activity, laboratory measurements and clinical outcomes, medical treatment data, PROs, and 
PGA of Disease activity. 

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Variables – include exposures, outcomes, and key co-variates 
Data Sources 
Case report forms will be designed to gather the data needed for the study that is collected as 
part of local standard of care of the study patients.  Clinical information recorded in the 
patients’ medical charts and/or diagnostic reports will be abstracted and entered into the EDC 
system.  As well, patients will complete the PRO questionnaires.  
Sample Size and Data Analysis 
The study will enrol approximately 1500 patients with RA, AS, or PsA. To effectively 
describe the BDMARD naive and CT-P13™ switch populations, approximately 650 of the 
patients enrolled are expected to be switched from Remicade®, while the remainder will be 
patients enrolled are expected to be BDMARD naive. After 18 month of enrolment, 
enrolment for the study ended on 31st of December 2016 for futility when 351 patients had 
been enrolled.  The study is designed to meaningfully characterize the RA, AS, and PsA 
populations and drug utilization patterns associated with the use of CT-P13™, as well as its 
safety and effectiveness.  The sample size is not driven by power calculations; all analyses 
will be descriptive in nature.  
A statistical analysis plan (SAP) will provide further level of detail to analysis planned to be 
applied to the data derived from the study.  Given the expected heterogeneity of patients 
commonly seen in observational studies, patients will be stratified appropriately based on 
final data available for analysis. 

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4. AMENDMENTS AND UPDATES 
Amend-
ment 
number 
Date 
Substantial or 
administrative 
amendment 
Protocol 
section(s) 
changed  
Summary of amendment(s) 
Reason 
01 
17 March 2017 
Substantial 
All (change in 
template used) 
1. 
Inclusion criteria for 
Informed Consent Form 
(ICF) signature added 
2. 
Safety reporting 
requirement updated 
including Pfizer safety 
reporting details  
3. 
Updated number of 
countries participating in 
the study 
4. 
Updated to Pfizer Protocol 
Template language. 
5. 
Removal of Exploratory 
Objective
 
 
6. 
Changed from Hospira 
Protocol Template to Pfizer 
Protocol Template. 
7. 
Language added to indicate 
enrolment has ended.  
8. 
Switched naming  of drug 
from Inflectra to CT-P13 
9. 
Removal of Product 
Monograph as reference 
safety documen 
 
1. 
Add to clarify 
requirement of ICF as 
a requirement for 
patient enrolment 
2. 
Updated to align with 
Pfizer’s processes 
3. 
Updated to current 
numbers of countries 
4. 
Updated to align with 
Pfizer’s processes 
5. 
Removed due to lack 
of sample size 
6. 
Updated to align with 
Pfizer’s processes. 
7. 
Updated language to 
show total number of 
patients enrolled 
8. 
Switched to molecular 
name 
9. 
Switched to using a 
single safety reference 
document for the 
study. 
 
C
C

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5. MILESTONES 
Milestone 
Planned date 
Start of data collection  First Subject First Visit 
(FSFV) 
10 September 2015 
End of data collection Last Subject Last Visit 
(LSLV).   
31 December 2018 
Final study report 
02 May 2019 
 
6. RATIONALE AND BACKGROUND 
Rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) are 
inflammatory conditions that typically cause chronic arthritis with variable localization.1  
Timely use of disease-modifying antirheumatic drugs (DMARDs) is an essential aspect of 
disease management, but many patients may not respond even when conventional agents are 
used optimally.2  Widespread use of biologic disease modifying anti rheumatic drugs 
(BDMARDs), including anti tumor necrosis factor (TNF) agents, has revolutionized the 
treatment of these disease entities as evident by a number of randomized controlled trials in 
each of these indications.3,4  Remicade® (infliximab, Janssen Biologics B.V.), an IgG1 
(Immunoglobulin G) chimeric human-murine monoclonal antibody (mAb), was approved in 
Europe in August 1999 and has been widely used in the treatment of RA, AS, and PsA.5   
Infliximab was designed to bind to tumour necrosis factor-α (TNF-α), and prevent it from 
binding to its receptors.8  Remicade® (infliximab, Janssen Biotech, Inc.), an IgG1 chimeric 
human-murine monoclonal antibody (mAb), was approved in Europe in August 1999 and has 
been widely used in the treatment of RA, AS, and PsA.5 
In September 2013, CT-P13™ (infliximab), a biosimilar to the reference product Remicade® 
(infliximab), was approved by the European Medicines Agency (EMA) based on an 
extensive non clinical and clinical comparability exercise between these two versions of 
infliximab.  This rigorous comparison demonstrated similar quality, pharmacokinetics, 
efficacy, and safety between CT-P13™ and Remicade®. Marketing authorization of 
CT-P13™ in the European Union (EU) includes all approved indications of Remicade® 
including RA, AS and PsA.6, Health Canada approved CT-P13™ for RA, AS, PsA, and 
plaque psoriasis in January of 2014.7 
The approvals of CT-P13™ in Europe and Canada have added a new choice for 
rheumatologists in their armamentarium of biologic disease modifying anti rheumatic drugs 
(BDMARDs) to treat RA, AS, and PsA. CT-P13™ is now broadly available for prescription 
in both regions.  Consistent with the basic premise of biosimilars, CT-P13™ is expected to 
provide the similar quality, efficacy, and safety as Remicade®.  On this basis, 
rheumatologists have provided feedback that they would consider CT-P13™ in varied 

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settings in their RA, AS, and PsA patients including BDMARD naive patients, and as an 
alternative in stable patients receiving Remicade®. 
The confirmatory clinical trial program conducted for the regulatory assessment of CT-P13™ 
included 2 large, double-blind, randomised clinical trials: a phase I-type Programme 
evaluating CT-P13™ in ankylosing spondylitis (PLANETAS) in 250 patients, and a phase 
III-type study Programme evaluating CT-P13™ in rheumatoid arthritis (PLANETRA) in 
606 patients.  These 2 studies demonstrated that the pharmacokinetics and clinical efficacy of 
CT-P13™ were essentially equivalent based on pre-specified criteria to that of Remicade®, 
and that the 2 treatments were well tolerated with comparable immunogenicity and safety 
profiles.  Long-term extension studies followed both PLANETAS and PLANETRA in 
patients completing 54 weeks of study. Patients in the CT-P13™ study arms received an 
additional 54 weeks of open-label CT-P13™, while patients in the Remicade® treatment 
arms were then switched to open-label CT-P13™ for an additional year.  After 54 weeks, 
clinical efficacy, safety, immunogenicity, and tolerability were found to be highly 
comparable between the patients groups who maintained CT-P13™ and those who switched 
from Remicade® to CT-P13™.9-11 
This prospective observational study has therefore been designed to characterize biologic 
naive RA, AS, and PsA patients receiving CT-P13™ or those switched to CT-P13™ from 
stable treatment with Remicade®. 
Real-life drug persistence has been suggested as a simple, practically relevant, indirect 
approach for assessing long-term therapeutic benefit and potential harm.  This suggestion is 
based on the assumption that when using a drug that reduces symptoms and prevents 
complications, patients persist with the treatment as long as they experience or perceive a 
benefit and do not experience (or perceive) an unacceptable amount of harm.  This 
theoretical perspective on persistence seems to be applicable to TNF antagonist drugs.  
Historically, the primary reasons for discontinuing or switching these drugs in RA for 
example appears to be decreased benefit (36–67% of the discontinuations) or perceived harm 
(30–58%).12-22  
Persistence, as one outcome of the study, is defined as a continuous variable to be measured 
in time from index until drug discontinuation.  Drug discontinuation will be defined as either 
switching to another non infliximab BDMARD or elapsing of a drug free interval of 
16 weeks (ie, 2 skipped doses).  For patients undergoing a switch to CT-P13™ from 
Remicade®, the index date will be considered the date from which Remicade® was 
originally commenced and for patients who initiated treatment with CT-P13™ as their first 
biologic, the index date will be considered the date from which CT-P13™ was initiated.  All 
patients will be followed for up to 2 years after enrolment. 
The real world data collection in this study will not interfere with the usual care of patients, 
and will not mandate specific diagnostic interventions, treatments or study visits. 

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Data generated from this study could be used to better define significant prognostic 
characteristics and guide short-term management and maintenance treatment decisions and to 
identify unmet medical needs, monitor the safety and impact of novel biosimilar medication, 
and direct future research. 
7. RESEARCH QUESTION AND OBJECTIVES 
7.1. Primary Study Objectives 
• To evaluate real-life drug persistence in rheumatoid arthritis (RA), ankylosing 
spondylitis (AS), and psoriatic arthritis (PsA) patients who are either initiated with 
CT-P13™ as their first biologic, or who are switched from stable Remicade®; 
• To characterise the populations and drug utilization patterns of RA, AS, and PsA 
patients who are either initiated with CT-P13™ as their first biologic, or who are 
switched from stable Remicade®; 
• To assess the safety of CT-P13™ in RA, AS, and PsA patients who are either 
initiated with CT-P13™ as their first biologic or who are switched from stable 
Remicade® for up to 2 years including: 
• Serious adverse events (SAE); 
• Adverse events of special interest (AESI); 
• Adverse events (AE). 
7.2. Secondary Study Objectives 
• To assess effectiveness of CT-P13™ in the treatment of patients with RA, AS, or PsA 
as measured by:  
• the Disease Activity Score (DAS28) in RA and PsA patients, Ankylosing 
Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis 
Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional 
Index for AS patients (BASFI) in AS patients over the study period. 
• To assess Patients reported Outcomes as measured by:  
• the Health Assessment Questionnaire Disability Index (HAQ-DI) for all patients;  
• the Short Form 12-version 2 (SF-12v2) for all patients); 
• the EuroQol 5-dimensions 3-levels for all patients over the study period. 
• To assess the Physician Global Assessment (PGA) over the study period. 

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8. RESEARCH METHODS  
8.1. Study Design 
This is a multi-national, prospective, observational study of RA, AS, and PsA patients 
enrolled after having already been deemed suitable by their physicians for treatment with 
CT-P13™, either as BDMARD naive or after a switch from stable treatment with 
Remicade®. The study will not interfere with the usual care of patients, and neither study 
visits nor specific diagnostic interventions will be mandated.  The decision to initiate 
treatment with CT-P13™ or to switch from stable treatment with Remicade® to CT-P13™, 
as well as the decision to enrol a particular patient in the study will be entirely the 
physician´s responsibility and according to the prescribing recommendation in the particular 
country.  Only patients meeting all eligibility criteria may be invited to enrol in the study.  
For each eligible patient, informed consent must be obtained prior to any study related 
activities. 
In order to meaningfully characterize the RA, AS, and PsA populations and drug utilization 
patterns associated with the use of CT-P13™, as well as its safety and effectiveness, the 
study plans to enrol approximately 1500 patients in a mix of academic and community sites 
in approximately 9 countries in Europe and Canada.  To effectively describe the BDMARD 
naive and CT-P13™ switch populations, approximately 650 of the patients enrolled are 
expected to be switched from Remicade®, while the remainder will be patients enrolled are 
expected to be BDMARD naive.  All patients are expected to be enrolled over an 
approximate 16 month period, with each patient followed for up to 2 years.  After 18 months 
of enrolment, enrolment for the study ended on 31st of December 2016 for futility when 
351 patients had been enrolled.  Enrolled patients who permanently discontinue infliximab 
(CT-P13™ or Remicade®) treatment will be encouraged to remain in the study and be 
followed for the remainder of the study period using a simplified case report form (CRF).  
There will be no study visits mandated per the study protocol.  Patients’ visit schedules will 
follow local standard of care typically coinciding with the schedule of infusions of 
CT-P13™, with additional visits as needed at the treating physician’s discretion.  Data for the 
study will be entered into an electronic data capture (EDC) system at enrolment and then 
approximately every 2-6 months thereafter up to 2 years.  Additional data captured will 
include demographics, drug utilization patterns, safety, clinical outcomes, and patient 
reported outcomes (PROs).  The sample size is not driven by power calculations; all analyses 
will be descriptive in nature. 
8.2. Setting 
8.2.1. Regions/Number of Study Sites 
The study will take place in countries in which CT-P13™ and Remicade® are authorized for 
the treatment of RA, AS, and PsA.  A heterogeneous sample of approximately 100 sites is 
planned to be recruited in Canada and Europe.  This will include a mix of academic and 
community centres to ensure broad physician and patient representation. 

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8.2.2. Enrolment 
The study plans to enrol approximately 1500 patients with approximately 650 of the enrolled 
patients being switched to CT-P13™ from stable Remicade®. Enrolment will be closely 
monitored in real time through the EDC system. 
All patients who meet the enrolment criteria are potentially eligible and may be invited to 
participate in the study.  Sites will be asked to record limited, de-identified, information on 
all potentially eligible patients who present to the practice, whether or not they consent and 
are enrolled in the study.  This information will include age, gender, the reason for not 
enrolling in the study (if applicable), and the date the patient enrolled (if applicable).  This 
information will be used to evaluate how likely the study sample compares to the total 
population receiving infliximab that are screened at the participating sites. 
8.2.3. Patient Eligibility 
The target study population will include biologic naive RA, AS, and PsA patients receiving 
CT-P13™ or those switched to CT-P13™ from stable treatment with Remicade®. 
8.2.3.1. Inclusion Criteria    
Patients must meet all of the following inclusion criteria to be eligible for inclusion in 
the study 
1. Patients aged ≥ 18 years old at the time of enrolment. 
2. Patients who are prescribed CT-P13 or Remicade for the treatment of RA, AS or PsA 
prescribed according to the corresponding summary of product characteristics (SmPC 
and Product Monograph) as determined by the investigator. 
3. Patients have consented to participate in the study.  
Evidence of a personally signed and dated informed consent document indicating that the 
patient (or a legally acceptable representative) has been informed of all pertinent aspects of 
the study. 
8.2.3.2. Exclusion Criteria 
Patients meeting any of the following criteria will not be included in the study 
1. Any reported contraindications for CT-P13 according to the SmPC. 
2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its 
excipients or other murine proteins, at the time of enrolment. 
8.3. Study Variables 
8.3.1. Minimum data set (variables to be collected) 
The study protocol does not mandate treatments, nor does it dictate what medical information 
should be entered into patient charts.  Rather, each participating site provides and documents 

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patient care and outcomes according to usual care, physician discretion and local practice 
standards.  Thus, study variables may not be available for all patients at all data collection 
time points if data are not recorded in the chart as per routine medical care.  
The study variables to be collected include: 
1. Patient demographics [Enrolment] 
• Age; 
• Gender; 
• BMI (body mass index). 
2. All clinically relevant (RA, AS, PsA) medical history and prior treatment including 
[Enrolment] 
• Extra-articular manifestations 
3. Clinical assessment of disease activity including [Enrolment and over the study 
period] 
• Clinician evaluation of disease activity at each routine visit–  
a. DAS 28 (eg, swollen joint count (SJC) 28/tender joint count (TJC) 28) 
b. ASDAS/BASDAI  
c. Physical function: BASFI for AS patients 
• Patient self-rated symptoms where clinician evaluation is missing  
a. Number of Tender/Swollen joints (swollen joint count [SJC]28/tender joint 
count [TJC]28) 
b. Spinal pain and stiffness (for axial AS) 
c. Enthesitis/dactylitis (for peripheral AS/PsA) 
d. Fatigue  
e. Pain/Discomfort  
4. Laboratory Measurements and Clinical Outcomes at the Investigators discretion 
[Enrolment and over the study period] 
5. Medical Treatment [Enrolment and over the study period] 
• Corticosteroids (oral, intravenous, or intra-articular) 

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• BDMARDs and non-biologic DMARDs 
• Nonsteroidal anti-inflammatory drugs  
• Other co-medication  
• Medication(s) related to the management of SAE or AESI 
6. Patient reported outcomes [Enrolment and over the study period]  
• EQ-5D-3L 
• SF-12v2 
• Quality of Life measured by HAQ-DI  
7. Data collected after initial Diagnosis [Enrolment and over the study period] 
• Physician’s Global Assessment of Disease activity measured on a visual analogue 
scale (VAS) 
 
Clinical evaluation of disease 
activity/ Functional indexes 
Patient Reported  
Outcomes 
Physi
cian 
report
ed 
Outco
mes 
Patient self-rated symptoms where clinician 
evaluation is missing 
 
DAS28 
23 
ASD
AS24 
BASD
AI*25 
BASFI*
26 
HAQ-
DI 
EQ-
5D-
3L 
SF
-1
2 
PGA 
TJ
C-
28 
SJ
C-
28 
Spin
al 
Pain 
and 
stiffn
ess 
Enthesiti
s/ 
Dactyliti
s 
Fatig
ue 
Pain/ 
Discom
fort 
R
A 
X 
 
 
 
X 
X 
X 
X 
X 
X 
 
 
X 
X 
Ps
A 
X 
 
 
 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
AS 
 
X 
X 
X 
X 
X 
X 
X 
 
 
X 
X 
X 
X 
*Self-reported questionnaire 
RA: rheumatoid arthritis; PsA: psoriatic arthritis; AS: ankylosing spondylitis; DAS: Disease Activity Score; ASDAS: 
Ankylosing Spondylitis Disease Activity Score; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASFI: 
Bath Ankylosing Spondylitis Functional Index; HAQ-DI: Health Assessment Questionnaire Disability Index; EQ-5D-3L: 
EuroQol 5-dimensions 3-levels; SF-12: Short Form 12; PGA: Physician Global Assessment; TJC: tender joint count; SJC: 
swollen joint count 
 
8.3.2. Patient Reported Outcomes for assessment of Health Related Quality of Life: 
The assessment of Health Related Quality of Life (HRQoL) is covered with the HAQ-DI, 
EQ-5D-3L and the SF-12v2.  These 3 instruments all have properties that justify their 
inclusion.  The HAQ-DI is a reliable and valid measure of functional activities and the 
EQ-5D-3L is preference based utility measure.  With the addition of the SF-12v2 there is a 
comprehensive assessment of HRQoL. 

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The SF-12v2 is a brief self-reported tool that provides a general sense of the impact of RA on 
eight domains.  The domains of the SF-12v2 tap into different areas affected by RA than the 
HAQ-DI.  Thus having them both provides a more comprehensive description of the impact 
of RA on HRQoL.  The SF-12v2 results can also be converted to produce utility scores. 
Patient reported outcomes Translation Readiness: 
Patient reported outcomes will be available in all target languages. List of study countries 
and languages are provided in Annex 6.  
8.3.3. Data Sources  
An EDC system will be utilized for data collection, monitoring, and quality control.  Data 
validation will be programmed in the EDC system to automate data queries.  Case report 
forms will be designed to gather the data needed for the study that is collected as part of local 
standard of care of the study patients.  Clinical information recorded in the patients’ medical 
charts and/or diagnostic reports will be abstracted and entered into the EDC system.  As well, 
patients will complete the PRO questionnaires. 
Enrolment and Data Collection 
Upon provision of informed consent, clinical and socio demographic characteristics, 
co-morbidities, medications and PRO data will be collected.  All study data required from the 
enrolment into the study will be collected prospectively from the date of receipt of informed 
consent.  Upon enrolment, data will be obtained from the chart retrospectively from the date 
of informed consent (6 months), and prospectively from time of consent to end of study.  
Follow up Period Physician Reported Data collection 
Following enrolment into the study, neither sites nor patients will be prompted to visit the 
study site except the pre-planned visits for CT-P13™ infusions.  At these visits, study site 
staff will collect treatment patterns and outcomes, vital status, clinical events, SAEs, and 
non-serious AE data from the charts of study patients followed at the participating sites.  At 
the time of these visits patients will be requested to complete PRO questionnaires (including 
EQ-5D-3L) as per the data collection schedule (Table 1) as deemed appropriate by the 
investigator. 
Clinical information recorded in patients’ medical charts and/or diagnostic reports will be 
abstracted and entered into the EDC system, as well as the completed PROs.  Table 1 
summarises the data collection schedule of the study. 
Drug discontinuation visit 
Patients who discontinue infliximab treatment will be followed for the remainder of the study 
period using simplified CRF.  For the drug discontinuation visit, reasons for discontinuation 
(free text), current co-medications (and dosage for RA drugs), SAEs, and non-serious AEs, 
PGA (mandatory) will be collected.  Starting with this discontinuation visit, only these 
parameters will be collected in the study. 

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Table 1. 
Study Data Collection Schedule 

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Table 1. 
Study Data Collection Schedule 
Infusion visits* over the 2-year study period) 
BV 
1 
2 
3 
4 
5 
6 
7 
8 
Additional visits 
as needed per 
standard of care 
Enrolment: (~12 months) 
Documented patient informed consent  
X 
 
Informed consent (documented by primary caregiver) 
X 
Patient/study identification number (ID) 
X 
Inclusion/exclusion criteria check 
X 
Demographics 
X 
Diagnostics and clinical outcomes  
X 
RA/AS/PsA clinical history review up to 6 months prior to study 
enrolment 
X 
Follow-up (Over the 2-year study period) 
Co-morbidities 
X 
 
 
 
 
 
 
 
 
 
Laboratory measurements and clinical outcomes† 
X 
At the Investigators’ discretion  
Co-medication for RA, AS, PsA 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
RA, AS, PsA Diagnosis (in remission during the previous 6 
months)† 
X 
 
Study discontinuation (date and reason) 
Anytime during Enrolment or during the study period 
Drug discontinuation# 
Anytime during the study period 
Patient reported Outcomes§, clinical evaluation of disease activity and Physician’s Global Assessment of Disease activity‡ 
Physician’s Global Assessment of Disease activity measured on a 
visual analogue scale 
X 
X 
 
 
X 
 
 
X 
 
X 
Clinical evaluation of disease activity  
DAS 28, BASDAI, ASDAS, BASFI 
X 
X 
 
 
X 
 
 
X 
 
X 
Patient reported outcomes (PRO) 
HAQ-DI, EQ-5D-3L and SF-12v2  
X 
X 
 
 
X 
 
 
X 
 
X 
Patient self-rated symptoms where clinician evaluation is 
missing  
Number of Tender/swollen Joints (SJC28/TJC28) 
Spinal pain and stiffness for axial AS 
X 
X 
 
 
X 
 
 
X 
 
X 

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Table 1. 
Study Data Collection Schedule 
Infusion visits* over the 2-year study period) 
BV 
1 
2 
3 
4 
5 
6 
7 
8 
Additional visits 
as needed per 
standard of care 
Enthesitis/dactylitis (for peripheral AS/PsA) 
Fatigue 
Pain/Discomfort 
Safety Reporting 
AEs (other than AESIs) 
 
SAEs 
To be reported within 24 hours of becoming aware (from signed informed consent) 
AESIs 
To be reported within 24 hours of becoming aware (from signed informed consent) 
Special situations 
To be reported within 24 hours of becoming aware (from signed informed consent) 
AE: adverse event; AESI: adverse event of special interest; AS: ankylosing spondylitis; ASDAS: Ankylosing Spondylitis Disease Activity Score; BASFI: bath 
ankylosing spondylitis functional index; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BV: baseline visit; DAS 28: Disease Activity Score in 
28 Joints; EQ-5D-3L: EuroQol 5-dimensions 3-levels;; HAQ-DI Health Assessment Questionnaire Disability: Index; ID: identification number; PI: principal 
investigator; PGA: Physician Global Assessment; PRO: Patient Reported Outcome; PsA: psoriatic arthritis, RA: rheumatoid arthritis, SAE: serious adverse 
event, SF-12v2: Short Form 12 version 2; SJC: swollen joint count, TJC: tender joint count; WIC: written informed consent  
*eCRF at infusion and/or clinical visits (approx. at 8 weeks intervals: vital status, clinical events, resource utilization, AEs, SAEs)  
‡It is recommended that the questionnaires listed in this table are completed at least once in 6 months; the parameters listed in this table are suggested 
procedures for each visit only 
§Direct to patient reported quality of life and resource utilization (6 month intervals might be considered) 
†As per investigators’ discretion; should be re-done once in a period of 6 months 
#Patients who discontinue infliximab treatment will be followed for the remainder of the study period using simplified CRF. For the drug discontinuation visit, 
reasons for discontinuation (free text), current co-medications (and dosage for RA drugs), AESIs, SAEs, non-serious-AES, PGA (mandatory) will be collected. 
Starting with this discontinuation visit, only these parameters will be collected in the study 
 
 
 

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8.4. Study Size 
The study will enrol approximately 1,500 RA, AS, and PsA patients who are either initiated 
with CT-P13™ as their first biologic, or who are switched from stable Remicade®.  The 
study is designed to characterize the RA, AS, and PsA populations and drug utilization 
patterns associated with the use of CT-P13™, as well as its safety and effectiveness.  There is 
no calculation of power for this study because the objectives are descriptive rather than 
inferential. 
A statistical analysis plan (SAP) will provide further level of detail to analysis planned to be 
applied to the data derived from the study. 
8.5. Data Management  
8.5.1. Electronic Data Capture System 
The database will be designed using a secure web-based EDC study database.  Hospira, a 
Pfizer company, will contract a third party vendor in accordance with written security 
policies. 
8.5.2. Data Entry 
All reported data from the enrolled investigator’s site will be entered via a secure web-based 
EDC study database.  All sites will be fully trained in using the EDC system, including eCRF 
completion guidelines.  Site personnel will be provided with secure usernames and 
passwords in order to enter study data into the EDC system.  All participating sites will only 
have access to view and enter the data for their own patients.  A data manager will perform 
concurrent review during the course of the data collection period.  The data manager will 
generate ad-hoc queries to sites when required, and the site management team will follow-up 
to request completion of such queries. 
8.5.3. Statistical Software 
All analyses will be performed using statistical analysis software (SAS) for Microsoft 
Windows operating system statistical software (SAS Institute, Cary, North Carolina, 
USA) version 9.2 or higher, using validated implementations of each application or SAS 
custom programming. 
8.6. Data Analysis 
Detailed methodology for summary and statistical analyses of data collected in this study will 
be documented in a Statistical Analysis Plan (SAP), which will be dated, filed and 
maintained by the sponsor.  The SAP may modify the plans outlined in the protocol; any 
major modifications of primary endpoint definitions or their analyses would be reflected in a 
protocol amendment. 

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Considering the observational design of the study and its objectives, the statistical analysis 
will be descriptive in nature.  Descriptive statistics for continuous variables will include the 
number of observations (N), mean, median, standard deviation (SD), minimum and 
maximum.  For categorical variables, N and percent will be provided. 
Patient enrolment will not be stratified by clinical subgroups, but analyses will describe 
patient characteristics and study outcomes for the sub populations or combinations thereof: 
• Treatment with CT-P13™ for RA, AS, or PsA; 
• Treatment with CT-P13™ in naive patients and those who switch from Remicade®; 
• Treatment discontinuation due to loss of efficacy;  
• Treatment discontinuation due to perceived harm. 
There is an option to conduct one or more interim analyses during the course of the study. 
8.6.1. Demographic and Baseline Characteristics 
The demographic and baseline characteristics of patients enrolled will be summarized 
overall, by disease and population sub-groups. 
Baseline value will be defined as the most recent value measured prior to onset of study drug 
infusion. 
8.6.2. Study Drug Utilization 
The total dose of study drug infused, and the length of infusion (minutes) will be summarized 
descriptively overall and by disease sub-groups. 
8.6.3. Real-life Drug Persistence 
Persistence is defined as the time from index until study drug discontinuation. Study drug 
discontinuation will be defined as either switching to another non infliximab BDMARD or 
elapsing of a drug free interval of 16 weeks (ie, 2 skipped doses).  For patients undergoing a 
switch to CT-P13™ from Remicade®, the index date will be considered the date from which 
Remicade® was originally commenced and for patients who initiated treatment with 
CT-P13™ as their first biologic, the index date will be considered the date from which 
CT-P13™ was initiated. 
Descriptive statistics for persistence, as a continuous variable will include N, mean, median, 
SD, minimum, and maximum. 
8.6.4. Safety Variables 
In this study, all SAEs and AEs will be collected. 

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8.6.4.1. Adverse Events 
The number and percentage of patients with AEs will be summarized overall and by disease 
and population sub-groups according to Medical Dictionary for Regulatory Activities 
(MedDRA) system organ class and preferred term.  
A data listing will be provided for all AEs including those reported within the 2 year study 
period. 
8.6.4.2. Adverse Events of Special Interest 
The MedDRA adverse event (AE) dictionary (most recent, available version at the time of 
study initiation) will be used to map AESI descriptions to preferred terms and system organ 
classes.  An AESI will be considered to be treatment-emergent if the event started or 
worsened in severity after the start of study drug infusion up to 24 hours after discontinuation 
of study drug infusion. Only the treatment-emergent AESIs will be analyzed.  However, all 
AESIs will be presented in data listings. 
The number and percentage of patients with treatment-emergent AESIs will be summarized 
overall and by disease and population sub-groups according to MedDRA system organ class 
and preferred term.  Category of AESI severity and category of AESI relationship to study 
drug will be summarized overall and by disease and population sub-groups.  For each 
subject, only the most severe category and the closest relationship will be counted. 
8.6.4.3. Serious Adverse Events 
The number and percentage of patients with treatment-emergent SAEs will be summarized 
overall and by disease and population sub-groups according to MedDRA system organ class 
and preferred term.  Category of SAE relationship to study drug will be summarized overall 
and by disease and population sub-groups. 
A data listing will be provided for all SAEs including those reported within the 2 year 
follow-up period. 
8.6.5. Effectiveness 
Disease Activity Score, including change from baseline, will be summarized by visit using 
descriptive statistics for RA and PsA patients.  On the other hand, ASDAS, BASDAI, and 
BASFI will be summarized for AS patients.  A listing of all measures of effectiveness will be 
generated. 
8.6.6. Patient Reported Outcomes 
8.6.6.1. Health Related Quality of Life 
The Health Assessment Questionnaire Disability Index scores will be summarized overall 
and by population sub-groups.  

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8.6.6.2. EuroQoL 5-dimensions 3-levels 
Results of the EQ-5D-3L will be presented as a measure of overall self-rated health status. 
Mean, SD, median, 1st and 3rd quartiles will be presented by disease and population 
sub-groups. 
8.6.6.3. Patient’s General Health Assessment 
The SF-12v2 scores will be summarized descriptively per visit assessments.  Technical 
details of computation will be discussed in the SAP. 
8.6.7. Physician’s Global Assessment  
Scores of PGA of Disease Activity measured on a VAS, including change from baseline will 
be summarized by study visit. 
8.7. Quality Control and Quality Assurance 
The study will be conducted following International Conference on Harmonisation guidance 
for industry Good Clinical Practices (E6).27  Quality Assurance representative(s) of Hospira 
(or their designee) may conduct audit visits at any time during the study period.  All 
necessary related data and documents will be made available for inspection. 
8.7.1. Site Training and Initiation 
The Sponsor or their designee will train the investigators (treating physicians) and their site 
staff on the study requirements and use of the EDC system.  Sponsor or their designee will 
contact each site to review site initiation procedures.  Ongoing site management will occur 
throughout the entire duration of the study.  Additional outreach and training including 
on-site visits will occur for sites (investigators and staff) needing additional training and to 
address quality concerns prior to analysis. 
8.7.2. Site Monitoring 
Monitoring of the study site via visits or remote monitoring will be made periodically during 
the study to ensure that all aspects of the protocol are followed.  Source documents will be 
reviewed for verification of data recorded on the eCRFs.  Source documents are defined as 
original documents, data, and records.  The investigator and institution guarantee access to 
source documents by the sponsor or its designee (contract research organization) and by the 
Institutional Review Board/Independent Ethics Committees (IRB or IEC) and Regulatory 
authorities. 
All aspects of the study and its documentation will be subject to review by the sponsor or 
designee, including but not limited to the Investigator’s binder, study medication, subject 
medical records, informed consent documentation, documentation of subject authorization to 
use personal health information (if separate from the ICFs), and review of eCRFs and 
associated source documents.  It is important that the investigator and other study personnel 
are available during the monitoring visits and that sufficient time is devoted to the process. 

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8.8. Limitations of the Research Methods 
8.8.1. Lost to Follow-up 
All patients will be followed for up to 2 years.  If a patient misses more than 1 usual care 
visit, the site will attempt to communicate with the patient and document the patient’s reason 
for not returning.  Sites will be requested to attempt to contact patients at various times of the 
day and evening, and on different days of the week.  If the patient cannot be contacted after 
the due diligence process, the treating physician will attempt to contact the patient’s 
designated secondary contacts, including the patient’s general practitioner and next of kin or 
out-of-household contacts to obtain information on the patient’s whereabouts and vital status.  
If the patient’s care has been transferred to another healthcare professional, the treating 
physician at the enrolling site will be responsible for obtaining the required follow-up 
information from the new treating physician.  Patients who do not return for at least 
2 scheduled visits, and for whom no information is available will be considered lost to 
follow-up. 
8.8.2. Study Limitations 
Internationally, real-life data is increasingly used in the development of clear, evidence-based 
documentation for demonstrating value.  With the diverse and growing number of 
stakeholders making treatment and purchasing decisions today, demonstrating product value 
in both clinical and economic terms is critical to achieving successful reimbursement and 
central to enabling the costs and benefits of competing health technologies to be quantified 
for funding decisions. 
Collecting real-life data from various sources includes patient data, data from clinicians, 
hospital data, data from payers and social data.  Through its use alongside traditional data 
sources such as clinical trials, an observational study has the potential to provide new 
insights into medicines and their effects in the context of different patient groups.  This very 
much applies to use of the new infliximab biosimilar – CT-P13™ in a diverse spectrum of 
patients with different types of rheumatic disease. 
There are a number of issues, however, which confound the collection of real-life data.  In 
Europe, for example, there is a lack of good quality and sufficiently representative databases 
in many countries - very different to the United States.  hose that exist are often not complete 
across different health care centers and may be focused on general practitioners or the 
hospital sector, but rarely cover all the different settings that play a role in medical treatment.  
The databases are also often missing data or contain poorly specified information (eg, on the 
severity of the condition).  

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Prospective data collection brings its own challenges.  Even with a careful controlled design, 
there may be various sources of bias that can completely distort the results.  One typical 
example applying to rheumatic disease entities is that different degrees of severity of a 
condition are treated with different drugs.  In consequence, a treatment that is actually more 
effective may look less successful in an observational study, if it is administered to the very 
severe cases only.  Besides, for patients switched from the originator product to the novel 
biosimilar, imposing a “six months previous stable condition under treatment with the 
originator” may introduce some degree of selection bias.  Thorough statistical methods can 
control parts of these biases, however the risk of misinterpreting study results without 
randomized drug allocation remains high.  With uncontrolled data, as in the case of the 
present study, there are even more sources of bias and confounding.  Treatment patterns 
sometimes differ considerably from one country to the other so prospective research must 
often be conducted in a series of countries to enable a meaningful picture to be presented to 
the local reimbursement authorities. 
8.9. Other Aspects 
8.9.1. National Leaders Committee 
A National Leaders Committee has been established which includes clinicians and scientists 
with expertise in RA, AS, and PsA, epidemiology and biostatistics, with a National Leader 
chosen for each country involved in the study.  Committee members will provide ongoing 
subject matter expertise for the program.  In collaboration with Hospira, the Committee will 
be responsible to review the data from the study over time, to make recommendations to 
Hospira regarding study conduct, and assist in study execution at the national and 
international levels . The Committee will be involved in case report form review and 
development, statistical analysis plan development and review, Clinical study report review, 
as well as publication development, if the findings from the study warrant publications in the 
future.  
8.9.2. Concomitant Medication Use 
As this is an observational study, where treatment decisions are left to the discretion of the 
treating physician, prescription of CT-P13™ or any other concomitant medication will not be 
influenced by the study protocol in any way.  Therefore, the current study protocol does not 
impose any restriction on the prescription of concomitant medications.  It is left to treating 
physician’s discretion taking into account local standard of care and SmPC directions.  With 
regard to co-therapy(ies), data on the following drug usage will be extracted from medical 
charts and entered into the EDC system: 
• Corticosteroids (oral, intravenous, intra-articular); 
• Non-steroidal anti-inflammatory drugs; 
• BDMARDs and non-biologic DMARDs; 
• Medication(s) related to the treatment of RA, AS, and PsA or management of the 
symptoms of RA, AS, and PsA; 

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• Medication(s) related to the management of SAE or AESI. 
Information on other types of concomitant medication will be recorded in the patients’ 
medical charts as per routine practice but will not be captured as part of study data. 
8.9.3. Regulatory Authorities  
The approved protocol will be submitted to Competent Authorities in accordance with the 
regulations of the countries and participating sites’ local clinical research regulatory 
requirements when applicable. 
8.9.4. Protocol Modifications 
Amendments to the protocol can only be made by Hospira.  All protocol amendments must 
be signed and dated by the investigator/ physicians, and if required, submitted and approved 
by the Regulatory Authorities and IRB/IEC, prior to implementation of the amendment.  The 
National Leaders Committee may provide feedback to Hospira on protocol modifications. 
8.9.5. Compensation to Investigators 
Study investigators will be compensated for time spent in completing study requirements 
consistent with local prevailing conditions.  This compensation schedule will be determined 
in accordance with national and local IRB/IEC guidelines and fair market value for the work 
performed. 
9. PROTECTION OF HUMAN SUBJECTS 
9.1. Patient Information and Consent 
All parties will ensure protection of patient personal data and will not include patient names 
on any sponsor forms, reports, publications, or in any other disclosures, except where 
required by laws.  In case of data transfer, Hospira will maintain high standards of 
confidentiality and protection of patient personal data. 
The informed consent form must be in compliance with local regulatory requirements and 
legal requirements. 
The informed consent form used in this study, and any changes made during the course of the 
study, must be prospectively approved by both the IRB/IEC and Hospira before use. 
The investigator must ensure that each study patient, or his/her legally acceptable 
representative, is fully informed about the nature and objectives of the study and possible 
risks associated with participation.  The investigator, or a person designated by the 
investigator, will obtain written informed consent from each patient or the patient’s legally 
acceptable representative before any study-specific activity is performed.  The investigator 
will retain the original of each patient's signed consent form. 
9.2. Patient withdrawal 
Patients may withdraw from the study at any time at their own request, or they may be 
withdrawn at any time at the discretion of the investigator or sponsor for safety, behavioral, 

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or administrative reasons.  In any circumstance, every effort should be made to document 
subject outcome, if possible.  The investigator should inquire about the reason for withdrawal 
and follow-up with the subject regarding any unresolved adverse events.   
If the patient withdraws from the study, and also withdraws consent for disclosure of future 
information, no further evaluations should be performed, and no additional data should be 
collected.  The sponsor may retain and continue to use any data collected before such 
withdrawal of consent. 
9.3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
It is the responsibility of the investigator to have prospective approval of the study protocol, 
protocol amendments, and informed consent forms, and other relevant documents, 
(eg, recruitment advertisements), if applicable, from the IRB/IEC.  All correspondence with 
the IRB/IEC should be retained in the Investigator File.  Copies of IRB/IEC approvals should 
be forwarded to Hospira.  
9.4. Ethical Conduct of the Study 
The study will be conducted in accordance with legal and regulatory requirements, as well as 
with scientific purpose, value and rigor and follow generally accepted research practices 
described in Guidelines for Good Pharmacoepidemiology Practices (GPP) issued by the 
International Society for Pharmacoepidemiology (ISPE), Good Epidemiological Practice 
(GEP) guidelines issued by the International Epidemiological Association (IEA), Good 
Practices for Outcomes Research issued by the International Society for Pharmacoeconomics 
and Outcomes Research (ISPOR), International Ethical Guidelines for Epidemiological 
Research issued by the Council for International Organizations of Medical Sciences 
(CIOMS), European Medicines Agency (EMA) European Network of Centres for 
Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological 
Standards in Pharmacoepidemiology, and FDA Guidance for Industry: Good 
Pharmacovigilance and Pharmacoepidemiologic Assessment, FDA Guidance for Industry 
and FDA Staff: Best Practices for Conducting and Reporting of Pharmacoepidemiologic 
Safety Studies Using Electronic Healthcare Data Sets, Guidance for Industry: 
Patient-Reported Outcome Measures: Use in Medical Product Development to Support 
Labeling Claims and/or equivalent 

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10. MANAGEMENT AND REPORTING OF ADVERSE EVENTS/ADVERSE 
REACTIONS  
The table below summarizes the requirements for recording safety events on the case report 
form (CRF) and for reporting safety events on the non-interventional study (NIS) adverse 
event monitoring (AEM) Report Form to Pfizer Safety.  These requirements are delineated 
for three types of events: (1) serious adverse events (SAEs); (2) non-serious AEs (as 
applicable); and (3) scenarios involving drug exposure, including exposure during pregnancy, 
exposure during breast feeding, medication error, overdose, misuse, extravasation, and 
occupational exposure.  These events are defined in the section “Definitions of safety 
events”.   
Safety event 
Recorded on the case report 
form 
Reported on the NIS AEM 
Report Form to Pfizer 
Safety within 24 hours of 
awareness 
SAE 
All 
All 
Non-serious AESI 
All 
Events that are actively 
sought. Actively sought 
events are designated as 
Adverse Events of Special 
Interest (AESI) in the study 
Scenarios involving 
exposure to a drug under 
study, including exposure 
during pregnancy, 
exposure during breast 
feeding, medication error, 
overdose, misuse, 
extravasation; lack of 
efficacy; and occupational 
exposure 
All (regardless of whether 
associated with an AE), 
except occupational 
exposure  
All (regardless of whether 
associated with an AE) 
 

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For each AE, the investigator must pursue and obtain information adequate both to determine 
the outcome of the adverse event and to assess whether it meets the criteria for classification 
as a SAE (see section "Serious Adverse Events” below)  
Safety events listed in the table above must be reported to Pfizer within 24 hours of 
awareness of the event by the investigator regardless of whether the event is determined 
by the investigator to be related to a drug under study.  In particular, if the SAE is fatal or 
life-threatening, notification to Pfizer must be made immediately, irrespective of the extent of 
available event information.  This timeframe also applies to additional new (follow-up) 
information on previously forwarded safety event reports. In the rare situation that the 
investigator does not become immediately aware of the occurrence of a safety event, the 
investigator must report the event within 24 hours after learning of it and document the time 
of his/her first awareness of the events. 
For safety events that are considered serious or that are identified in the far right column of 
the table above that are reportable to Pfizer within 24 hours of awareness, the investigator is 
obligated to pursue and to provide any additional information to Pfizer in accordance with 
this 24-hour timeframe.  In addition, an investigator may be requested by Pfizer to obtain 
specific follow-up information in an expedited fashion.  This information is more detailed 
than that recorded on the case report form.  In general, this will include a description of the 
adverse event in sufficient detail to allow for a complete medical assessment of the case and 
independent determination of possible causality.  Any information relevant to the event, such 
as concomitant medications and illnesses must be provided.  In the case of a patient death, a 
summary of available autopsy findings must be submitted as soon as possible to Pfizer or its 
designated representative.  
Reporting period 
For each patient, the safety event reporting period begins at the time of  the patient’s first 
dose of CT-P13™ or the time of the patient’s informed consent if s/he is already exposed to 
CT-P13™, and lasts through the end of the observation period of the study, which must 
include at least 28 calendar days following the last administration of a drug under study; a 
report must be submitted to Pfizer Safety (or its designated representative) for any of the 
types of safety events listed in the table above occurring during this period.  If a patient was 
administered a drug under study on the last day of the observation period, then the reporting 
period should be extended for 28 calendar days following the end of observation.  Most 
often, the date of informed consent is the same as the date of enrolment.  In some situations, 
there may be a lag between the dates of informed consent and enrolment.  In these instances, 
if a patient provides informed consent but is never enrolled in the study (eg, patient changes 
his/her mind about participation), the reporting period ends on the date of the decision to not 
enrol the patient.   
If the investigator becomes aware of a SAE occurring at any time after completion of the 
study and s/he considers the SAE to be related to CT-P13™, the SAE also must be reported 
to Pfizer Safety.  
Causality assessment 

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The investigator is required to assess and record the causal relationship.  For all AEs, 
sufficient information should be obtained by the investigator to determine the causality of 
each adverse event.  For AEs with a causal relationship to CT-P13™, follow-up by the 
investigator is required until the event and/or its sequelae resolve or stabilize at a level 
acceptable to the investigator, and Pfizer concurs with that assessment.   
An investigator’s causality assessment is the determination of whether there exists a 
reasonable possibility that CT-P13™ caused or contributed to an adverse event. If the 
investigator’s final determination of causality is “unknown” and s/he cannot determine 
whether CT-P13™ caused the event, the safety event must be reported within 24 hours.   
If the investigator cannot determine the etiology of the event but s/he determines that 
CT-P13™ did not cause the event, this should be clearly documented on the case report form 
(CRF) and the NIS AEM Report Form.  
DEFINITIONS OF SAFETY EVENTS 
Adverse events 
An AE is any untoward medical occurrence in a patient administered a medicinal product.  
The event need not necessarily have a causal relationship with the product treatment or 
usage.  Examples of adverse events include but are not limited to:   
• Abnormal test findings (see below for circumstances in which an abnormal test 
finding constitutes an adverse event); 
• Clinically significant symptoms and signs; 
• Changes in physical examination findings; 
• Hypersensitivity; 
• Progression/worsening of underlying disease;  
• Lack of efficacy;  
• Drug abuse;  
• Drug dependency. 
Additionally, for medicinal products, they may include the signs or symptoms resulting from: 
• Drug overdose; 
• Drug withdrawal; 
• Drug misuse;  

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• Off-label use;  
• Drug interactions; 
• Extravasation; 
• Exposure during pregnancy; 
• Exposure during breast feeding; 
• Medication error; 
• Occupational exposure. 
Abnormal test findings 
The criteria for determining whether an abnormal objective test finding should be reported as 
an adverse event are as follows:  
• Test result is associated with accompanying symptoms, and/or 
• Test result requires additional diagnostic testing or medical/surgical intervention, 
and/or 
• Test result leads to a change in study dosing or discontinuation from the study, 
significant additional concomitant drug treatment, or other therapy, and/or 
• Test result is considered to be an adverse event by the investigator or sponsor. 
Merely repeating an abnormal test, in the absence of any of the above conditions, does not 
constitute an adverse event.  Any abnormal test result that is determined to be an error does 
not require reporting as an adverse event. 
Serious adverse events 
A serious adverse event is any untoward medical occurrence in a patient administered a 
medicinal or nutritional product (including pediatric formulas) at any dose that: 
• Results in death; 
• Is life-threatening; 
• Requires inpatient hospitalization or prolongation of hospitalization (see below for 
circumstances that do not constitute adverse events); 

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• Results in persistent or significant disability/incapacity (substantial disruption of the 
ability to conduct normal life functions); 
• Results in congenital anomaly/birth defect. 
Medical and scientific judgment is exercised in determining whether an event is an important 
medical event.  An important medical event may not be immediately life-threatening and/or 
result in death or hospitalization.  However, if it is determined that the event may jeopardize 
the patient or may require intervention to prevent one of the other outcomes listed in the 
definition above, the important medical event should be reported as serious. 
Examples of such events are intensive treatment in an emergency room or at home for 
allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; 
or development of drug dependency or drug abuse. 
Additionally, any suspected transmission via a Pfizer product of an infectious agent, 
pathogenic or non-pathogenic, is considered serious.  The event may be suspected from 
clinical symptoms or laboratory findings indicating an infection in a patient exposed to a 
Pfizer product.  The terms “suspected transmission” and “transmission” are considered 
synonymous.  These cases are considered unexpected and handled as serious expedited cases 
by PV personnel.  Such cases are also considered for reporting as product defects, if 
appropriate. 
Hospitalization 
Hospitalization is defined as any initial admission (even if less than 24 hours) to a hospital or 
equivalent healthcare facility or any prolongation to an existing admission.  Admission also 
includes transfer within the hospital to an acute/intensive care unit (eg, from the psychiatric 
wing to a medical floor, medical floor to a coronary care unit, neurological floor to a 
tuberculosis unit).  An emergency room visit does not necessarily constitute a hospitalization; 
however, an event leading to an emergency room visit should be assessed for medical 
importance.  
Hospitalization in the absence of a medical AE is not in itself an AE and is not reportable. 
For example, the following reports of hospitalization without a medical AE are not to be 
reported.  
• Social admission (eg, patient has no place to sleep); 
• Administrative admission (eg, for yearly exam); 
• Optional admission not associated with a precipitating medical AE (eg, for elective 
cosmetic surgery); 
• Hospitalization for observation without a medical AE; 

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• Admission for treatment of a pre-existing condition not associated with the 
development of a new AE or with a worsening of the pre-existing condition (eg, for 
work-up of persistent pre-treatment lab abnormality); 
• Protocol-specified admission during clinical study (eg, for a procedure required by 
the study protocol). 
Adverse Events of Special Interest  
Adverse Events of Special Interest (AESIs) are AEs of scientific or medical concern specific 
to the product for which ongoing monitoring and rapid communication by the investigator to 
the sponsor can be appropriate.  The following list of AEs are classified as AESIs for this 
study: 
• Serious infections including sepsis (excluding opportunistic infections and 
tuberculosis);  
• Opportunistic infections;  
• Tuberculosis; 
• Bacillus Calmette–Guérin vaccine (BCG) breakthrough infection and agranulocytosis 
in infants with in utero exposure to infliximab;  
• Acute hypersensitivity reactions (including anaphylactic shock)*;  
• Serious infusion reactions during a re-induction regimen following disease flare;  
• Serum sickness (delayed hypersensitivity reactions);  
• Haematological reactions;  
• Systemic lupus erythematosus/lupus-like syndrome;  
• Lymphoma (not Hepatosplenic T-cell lymphoma (HSTCL));  
• Hepatosplenic T-cell lymphoma (HSTCL);  
• Leukaemia;  
• Merkel cell carcinoma;  
• Melanoma;  
• Cervical cancer;  
• Paediatric malignancy;  

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• Hepatobiliary events;  
• Hepatitis B virus (HBV) reactivation;  
• Congestive heart failure;  
• Demyelinating disorders;  
• Sarcoidosis/sarcoid-like reactions;  
• Intestinal or perianal abscess (in Crohn’s disease);  
• Malignancy (excluding lymphoma, HSTCL, paediatric malignancy, leukaemia, 
melanoma, Merkel cell carcinoma, cervical cancer);  
• Colon carcinoma/dysplasia (in ulcerative colitis);  
• Skin cancer (excluding melanoma, Merkel cell carcinoma);  
• Pregnancy exposure;  
• Infusion reaction associated with shortened infusion duration. 
Scenarios necessitating reporting to Pfizer Safety within 24 hours  
Scenarios involving exposure during pregnancy, exposure during breastfeeding, medication 
error, overdose, misuse, extravasation, lack of efficacy, and occupational exposure are 
described below. 
Exposure during pregnancy 
An exposure during pregnancy (EDP) occurs if: 
1. A female becomes, or is found to be, pregnant either while receiving or having been  
exposed to (eg, environmental) CT-P13™, or the female becomes, or is found to be, 
pregnant after discontinuing and/or being exposed to CT-P13™ (maternal exposure). 
An example of environmental exposure would be a case involving direct contact with 
a Pfizer product in a pregnant woman (eg, a nurse reports that she is pregnant and has 
been exposed to chemotherapeutic products). 

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2. A male has been exposed, either due to treatment or environmental exposure to 
CT-P13™ prior to or around the time of conception and/or is exposed during the 
partner pregnancy (paternal exposure). 
As a general rule, prospective and retrospective exposure during pregnancy reports from any 
source are reportable irrespective of the presence of an associated AE and the procedures for 
SAE reporting should be followed. 
If a study participant or study participant’s partner becomes, or is found to be, pregnant 
during the study participant’s treatment with CT-P13™, this information must be submitted 
to Pfizer, irrespective of whether an adverse event has occurred using the NIS AEM Report 
Form and the EDP Supplemental Form.  
In addition, the information regarding environmental exposure to CT-P13™ in a pregnant 
woman (eg, a subject reports that she is pregnant and has been exposed to a cytotoxic product 
by inhalation or spillage) must be submitted using the NIS AEM Report Form and the EDP 
supplemental form.  This must be done irrespective of whether an AE has occurred.   
Information submitted should include the anticipated date of delivery (see below for 
information related to termination of pregnancy). 
Follow-up is conducted to obtain general information on the pregnancy; in addition, 
follow-up is conducted to obtain information on EDP outcome for all EDP reports with 
pregnancy outcome unknown.  A pregnancy is followed until completion or until pregnancy 
termination (eg, induced abortion) and Pfizer is notified of the outcome.  This information is 
provided as a follow up to the initial EDP report.  In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth.  In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
pre-procedure test findings are conclusive for a congenital anomaly and the findings are 
reported). 
If the outcome of the pregnancy meets the criteria for an SAE (eg, ectopic pregnancy, 
spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly [in a 
live born, a terminated fetus, an intrauterine fetal demise, or a neonatal death]), the 
procedures for reporting SAEs should be followed. 
Additional information about pregnancy outcomes that are reported as SAEs follows:  
• Spontaneous abortion includes miscarriage and missed abortion; 
• Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs.  In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to investigational product. 

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Additional information regarding the exposure during pregnancy may be requested.  Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays).   
In the case of paternal exposure, the study participant will be provided with the Pregnant 
Partner Release of Information Form to deliver to his partner.  It must be documented that the 
study participant was given this letter to provide to his partner. 
Exposure during breastfeeding 
Scenarios of exposure during breastfeeding must be reported, irrespective of the presence of 
an associated AE.  An exposure during breastfeeding report is not created when a Pfizer drug 
specifically approved for use in breastfeeding women (eg, vitamins) is administered in 
accord with authorized use.  However, if the infant experiences an AE associated with such a 
drug’s administration, the AE is reported together with the exposure during breastfeeding. 
Medication error 
A medication error is any unintentional error in the prescribing, dispensing or administration 
of a medicinal product that may cause or lead to inappropriate medication use or patient harm 
while in the control of the health care professional, patient, or consumer.  Such events may 
be related to professional practice, health care products, procedures, and systems including: 
prescribing; order communication; product labeling, packaging, and nomenclature; 
compounding; dispensing; distribution; administration; education; monitoring; and use.   
Medication errors include: 
• Near misses, involving or not involving a patient directly (eg, inadvertent/erroneous 
administration, which is the accidental use of a product outside of labeling or 
prescription on the part of the healthcare provider or the patient/consumer); 
• Confusion with regard to invented name (eg, trade name, brand name). 
The investigator must submit the following medication errors to Pfizer, irrespective of the 
presence of an associated AE/SAE: 
• Medication errors involving patient exposure to the product, whether or not the 
medication error is accompanied by an AE. 
• Medication errors that do not involve a patient directly (eg, potential medication 
errors or near misses).  When a medication error does not involve patient exposure to 
the product the following minimum criteria constitute a medication error report: 
• An identifiable reporter; 
• A suspect product; 
• The event medication error. 

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Overdose, Misuse, Extravasation 
Reports of overdose, misuse, and extravasation associated with the use of a Pfizer product are 
reported to Pfizer by the investigator, irrespective of the presence of an associated AE/SAE.  
Lack of Efficacy 
Reports of lack of efficacy to a Pfizer product are reported to Pfizer by the investigator, 
irrespective of the presence of an associated AE/SAE or the indication for use of the Pfizer 
product. 
Occupational Exposure 
Reports of occupational exposure to a Pfizer product are reported to Pfizer by the 
investigator, irrespective of the presence of an associated AE/SAE. 
10.1. Single reference safety document 
The SmPC will serve as the single reference safety document (SRSD) during the course of 
the study, which will be used by Pfizer safety to assess any safety events reported to Pfizer 
Safety by the investigator during the course of this study.  
The SRSD should be used by the investigator for prescribing purposes and guidance. 
11. PLANS FOR DISSEMINATING AND COMMUNICATING STUDY RESULTS 
11.1. Reporting to Regulatory Agencies 
All reports will be submitted to the regulatory authorities by Hospira or designee based on 
country/region reporting requirements and pursuant to required timeframes. 
All serious related adverse events will be expedited within 15 days of receipt and non-serious 
relate adverse events within 90 days of receipt in the EU. 
11.2. Use of Information and Publications 
All data generated from this study are the property of Hospira. Hospira shall have the right to 
publish such data and information without approval from the sites.  Hospira will establish a 
uniform procedure for analysing, publishing, and disseminating findings from this study. 
Co-authors of publications may include participating physicians, Hospira personnel, 
members of the National Leaders Committee, and/or other relevant thought leaders who 
contribute substantially to the publication.  Data from planned interim analyses will be 
published by Hospira at time points deemed appropriate based on study progress. 
Publications will adhere to the International Committee of Medical Journal Editors 
guidelines. Study data may not be published by participating sites without review and 
authorisation by Hospira.  
COMMUNICATION OF ISSUES 

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In the event of any prohibition or restriction imposed (eg, clinical hold) by an applicable 
Competent Authority in any area of the world, or if the investigator is aware of any new 
information which might influence the evaluation of the benefits and risks of a Hospira 
product, Hospira should be informed immediately.   
In addition, the investigator will inform Hospira immediately of any urgent safety measures 
taken by the investigator to protect the study patients against any immediate hazard, and of 
any serious breaches of this NI study protocol that the investigator becomes aware of. 

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12. REFERENCES 
1. 
Salaffi F, Carotti M, Gasparini S, Intorcia M, Grassi W. The health-related quality of 
life in rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis: a comparison 
with a selected sample of healthy people. Health and quality of life outcomes. 
2009;7:25. 
2. 
Malottki K, Barton P, Tsourapas A, et al. Adalimumab, Etanercept, Infliximab, 
Rituximab and Abatacept for the Treatment of Rheumatoid Arthritis After the Failure of 
a Tumour Necrosis Factor Inhibitor: A Systematic Review and Economic Evaluation. 
Southampton (UK): NIHR Journals Library; 2011 Mar. (Health Technology 
Assessment, No. 15.14.) 1, Background. Available from: 
http://www.ncbi.nlm.nih.gov/books/NBK99678/.  
3. 
Tanaka T, Hishitani Y, Ogata A. Monoclonal antibodies in rheumatoid arthritis: 
comparative effectiveness of tocilizumab with tumor necrosis factor inhibitors. 
Biologics : targets & therapy. 2014;8:141-53.  
4. 
Lie E, Fagerli KM, Mikkelsen K, Rodevand E, Lexberg A, Kalstad S, et al. First-time 
prescriptions of biological disease-modifying antirheumatic drugs in rheumatoid 
arthritis, psoriatic arthritis and axial spondyloarthritis 2002-2011: data from the 
NOR-DMARD register. Annals of the rheumatic diseases. 2014;73(10):1905-6. 
5. 
REMICADE (infliximab) summary of product characteristics. Available at: 
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Informatio
n/human/000240/WC500050888.pdf; 2013 [accessed 25 Mar 2015].  
6. 
Committee for Medicinal Products for Human Use. European Medicines Agency. 
CT-P13™ summary of opinion (initial authorization) (2013) 
EMA/CHMP/364710/2013. Available at: 
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initi
al_authorisation/human/002778/WC500144831.pdf [accessed 25 Mar 2015]. 
7. 
Health Canada. Summary basis of decision – CT-P13™ (2014). Available at: 
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_CT-P
13_159493-eng.php [accessed 25 Mar 2015].  
8. 
Maini RN, Feldmann M. How does infliximab work in rheumatoid arthritis? Arthritis 
research. 2002;4 Suppl 2:S22-8.  
9. 
Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, et al. A randomised, 
double-blind, multicentre, parallel-group, prospective study comparing the 
pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients 
with ankylosing spondylitis: the PLANETAS study. Annals of the rheumatic diseases. 
2013;72(10):1605-12.  
10. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, et al. A 
randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy 

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Page 44 of 74 
 
and safety of CT-P13 compared with innovator infliximab when coadministered with 
methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Annals 
of the rheumatic diseases. 2013;72(10):1613-20.  
11. CT-P13TM. European Public Assessment Report (EPAR); EMEA/H/C/002778/0000; 
2013 [Online]. [cited 2015 May 08]. Available from: URL: 
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_
report/human/002778/WC500151490.pdf.  
12. Berthelot JM, Benoist-Gerard S, le Goff B, Muller-Chevalet F, Maugars Y. Outcome 
and safety of TNFalpha antagonist therapy in 475 consecutive outpatients (with 
rheumatoid arthritis or spondyloarthropathies) treated by a single physician according to 
their eligibility for clinical trials. Joint, bone, spine : revue du rhumatisme. 
2010;77(6):564-9.  
13. Carmona L, Gomez-Reino JJ. Survival of TNF antagonists in spondylarthritis is better 
than in rheumatoid arthritis. Data from the Spanish registry BIOBADASER. Arthritis 
research & therapy. 2006;8(3):R72.  
14. Fernandez-Nebro A, Irigoyen MV, Urena I, Belmonte-Lopez MA, Coret V, 
Jimenez-Nunez FG, et al. Effectiveness, predictive response factors, and safety of 
anti-tumor necrosis factor (TNF) therapies in anti-TNF-naive rheumatoid arthritis. The 
Journal of rheumatology. 2007;34(12):2334-42.  
15. Filippini M, Bazzani C, Favalli EG, Marchesoni A, Atzeni F, Sarzi-Puttini P, et al. 
Efficacy and safety of anti-tumour necrosis factor in elderly patients with rheumatoid 
arthritis: an observational study. Clinical reviews in allergy & immunology. 
2010;38(2-3):90-6.  
16. Hetland ML, Christensen IJ, Tarp U, Dreyer L, Hansen A, Hansen IT, et al. Direct 
comparison of treatment responses, remission rates, and drug adherence in patients with 
rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from 
eight years of surveillance of clinical practice in the nationwide Danish DANBIO 
registry. Arthritis and rheumatism. 2010;62(1):22-32.  
17. Hyrich KL, Lunt M, Watson KD, Symmons DP, Silman AJ. Outcomes after switching 
from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor 
alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort 
study. Arthritis and rheumatism. 2007;56(1):13-20.  
18. Kievit W, Fransen J, Adang EM, den Broeder AA, Bernelot Moens HJ, Visser H, et al. 
Long-term effectiveness and safety of TNF-blocking agents in daily clinical practice: 
results from the Dutch Rheumatoid Arthritis Monitoring register. Rheumatology 
(Oxford, England). 2011;50(1):196-203.  
19. Ogale S, Hitraya E, Henk HJ. Patterns of biologic agent utilization among patients with 
rheumatoid arthritis: a retrospective cohort study. BMC musculoskeletal disorders. 
2011;12:204.  

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20. Wolfe F. The epidemiology of drug treatment failure in rheumatoid arthritis. Bailliere's 
clinical rheumatology. 1995;9(4):619-32.  
21. Sokka T, Pincus T. Eligibility of patients in routine care for major clinical trials of 
anti-tumor necrosis factor alpha agents in rheumatoid arthritis. Arthritis and 
rheumatism. 2003;48(2):313-8.  
22. Fisher A, Bassett K, Wright JM, Brookhart MA, Freeman H, Dormuth CR. 
Comparative persistence of the TNF antagonists in rheumatoid arthritis--a 
population-based cohort study. PloS one. 2014;9(8):e105193.  
23. Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel 
PL. Modified disease activity scores that include twenty-eight-joint counts. 
Development and validation in a prospective longitudinal study of patients with 
rheumatoid arthritis. Arthritis and rheumatism. 1995;38(1):44-8.  
24. Lukas C, Landewe R, Sieper J, Dougados M, Davis J, Braun J, et al. Development of an 
ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitis. 
Annals of the rheumatic diseases. 2009;68(1):18-24.  
25. Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new 
approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing 
Spondylitis Disease Activity Index. The Journal of rheumatology. 1994;21(12):2286-91.  
26. Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, et al. A new 
approach to defining functional ability in ankylosing spondylitis: the development of the 
Bath Ankylosing Spondylitis Functional Index. The Journal of rheumatology. 
1994;21(12):2281-5.  
27. International Conference on Harmonisation Harmonised Tripartite Guideline. Guideline 
for Good Clinical Practice: E6 (R1), Current Step 4 version. 1996 Jun 10. 
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/
E6_R1_Guideline.pdf [accessed 26 Mar 2015].  
28. European Medicines Agency and Heads of Medicines Agencies. Guideline on good 
pharmacovigilance practices (GVP) – Annex I (Rev 3) EMA/876333/2011 Rev 3. 
Available at: 
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/
WC500143294.pdf [accessed 26 Mar 2015].  
13. LIST OF TABLES  
Not applicable. 
14. LIST OF FIGURES 
Not applicable.

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Appendix 1. ANNEX 1. LIST OF STAND ALONE DOCUMENTS 
 CT-P13™: Summary of Product Characteristics 
Remicade®: Summary of Product Characteristics 

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Appendix 2. ANNEX 2. HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY 
INDEX 
The Health Assessment Questionnaire Disability Index– is a reliable and valid measure of 
Health related quality of life (HRQoL) that is used in a variety of diseases, particularly 
rheumatologic conditions.  The HAQ-DI is used to evaluate 8 categories which represent a 
set of functional activities: dressing, rising, eating, walking, hygiene, reach, grip, and usual 
activities.  Each item is scored on 4-point scale from 0 to 3: 0 = without any difficulty; 1 = 
some difficulty; 2 = much difficulty; 3 = unable to do.  Overall score is computed as the sum 
of domain scores and divided by the number of domains answered.  Total possible score 
range 0-3 where 0 = least difficulty and 3 = extreme difficulty. 

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Appendix 3. ANNEX 3. PHYSICIAN GLOBAL ASSESSMENT OF DISEASE 
ACTIVITY 
Physician Global Assessment of Disease Activity is measured on a 0 to 10 cm VAS, where 0 
cm = No disease activity and 10 cm = extremely active. 
 
 
 

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Appendix 4. ANNEX 4. EQ-5D-3L 
The EQ-5D-3L is a measure of self-reported health outcomes.  It consists of two parts: a 
descriptive system (Part I) and a VAS (Part II).  Part I of the scale consists of 5 single-item 
dimensions including: mobility, self care, usual activities, pain/discomfort, and 
anxiety/depression.  Each dimension has a 3 point response scale designed to indicate the 
level of the problem.  Part II uses a vertical graduated VAS to measure health status, ranging 
from worst imaginable health state to best imaginable health state. 

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Appendix 5. ANNEX 5 SF-12v2 
The SF-12v2 is a general measure of HRQoL used in a wide variety of disease states.  The 
SF-12 includes eight subscales, as well as two summary measures: the Physical Component 
Summary (PCS), and the Mental Component Summary (MCS). 

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Appendix 6. ANNEX 6. STUDY COUNTRIES AND LANGUAGES 
[Delete highlighted blank rows below to clean up table.]
Country 
Languages 
Germany 
German 
 
 
Czech Republic & Slovakia 
Czech 
Slovak 
 
 
Belgium 
Dutch 
French 
German 
United Kingdom  
English 
Spain 
Spanish 
France 
French 
 
Canada  
French 
English 
Greece 
Greek 
Bulgaria 
Bulgarian 

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Appendix 7. ANNEX 7. DISEASE ACTIVITY SCORE IN 28 JOINTS 
 

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Appendix 8. ANNEX 8. BATH ANKYLOSING SPONDYLITIS FUNCTIONAL 
INDEX 
 

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Appendix 9. ANNEX 9. BATH ANKYLOSING SPONDYLITIS DISEASE ACTIVITY 
INDEX 
 
 
 

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Appendix 10. ANNEX 10. ANKYLOSING SPONDYLITIS DISEASE ACTIVITY 
SCORE 
Link online ASDAS calculator: 
http://www.asas-group.org/clinical-instruments/asdas_calculator/asdas.html 
 

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