A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Sponsor: Amgen

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PRA Health Sciences
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Medical Director (Internal Medicine)
PRA Health Sciences
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North America/Latin and South America
Phone: 1-800-772-2215/1-434-951-3489
FAX:
1-888-772-6919/1-434-951-3482
E-mail:  CHOSafety@PRAIntl.com
Europe, Asia, and Pacific Region 
Phone: +49.621.8782.154
FAX:  +44 1792 525 720
E-mail:   CHOSafety@PRAIntl.com
This study will be conducted in compliance with the protocol, Good Clinical Practice
(GCP) as set forth in the International Council for Harmonisation (ICH) guidelines on
GCP (ICH E6), and applicable local regulatory requirements.
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This document is a confidential communication of Amgen Inc. Acceptance of this document 
constitutes agreement by the recipient that no unpublished information contained herein shall be
published or disclosed without prior written approval, except that this document may be disclosed to 
the appropriate Institutional Review Board(s)/Independent Ethics Committee(s) under the condition 
that they keep it confidential.
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Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 3 of 82
Confidential
Investigator
I have read and agree to the Protocol 20140111, entitled “A RANDOMIZED, DOUBLE-
BLIND PHASE 3 STUDY TO ASSESS THE EFFICACY AND SAFETY OF ABP 710 
COMPARED TO INFLIXIMAB IN SUBJECTS WITH MODERATE TO SEVERE 
RHEUMATOID ARTHRITIS.” I am aware of my responsibilities as an Investigator
under the guidelines of GCP, local regulations (as applicable) and the study
protocol.
I agree to conduct the study according to these responsibilities and to 
appropriately direct and assist the staff under my control, who will be involved in the
study.
Study Center:
Study Center 
Number:
Study Center Principal Investigator
Print Name
Title
Signature
Date
Coordinating Investigator Signature:
Print Name
Title
Signature
Date

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 4 of 82
Confidential
2
SYNOPSIS
NAME OF SPONSOR:  AmgenInc.
PROTOCOL No.: 20140111
NAME OF STUDY TREATMENT:  ABP710
TITLE OF STUDY: A Randomized, Double-blind Phase 3 Study to Assess the Efficacy
and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe
Rheumatoid Arthritis
STUDY CENTERS: Approximately 90 study centers in Europe, North America, and
Australia
STUDY PERIOD: A total of up to 54 weeks, consisting ofa
screening period of up to 4 weeks, a treatment period of
46 weeks, and a safety, immunogenicity, and efficacy follow-
up period of 4 weeks. The end of the study will be the date 
when the last subject has completed the last study
assessment.
PHASE OF
DEVELOPMENT:
Phase 3
PLANNED STUDY DATES: The expected enrollment duration is 10.5 months, and
each subject will participate for up to 54 weeks.
OBJECTIVES:
Primary Objective: The primary objective for this study is to assess the efficacy of 
ABP710 compared with US-licensed infliximab (infliximab).
Secondary Objectives: The secondary objectives are to assess the safety and
immunogenicity of ABP 710 compared with infliximab.
STUDY DESIGN AND METHODOLOGY: This is a randomized, double-blind, active-
controlled study in adult subjects with moderate to severe rheumatoid arthritis (RA) who have 
an inadequate response to methotrexate (MTX). Approximately 550 subjects (275 per
treatment group) will be enrolled. The subjects will be randomized in a 1:1 ratio to receive
either ABP 710 3 mg/kg infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter
(treatment group A), or infliximab 3 mg/kg infusion on day 1, at weeks 2 and 6, and every
8 weeks thereafter (treatment group B), until week 22.
At week 22, subjects initially randomized to the infliximab group will be re-randomized in a
1:1 ratio to either continue receiving infliximab infusion every 8 weeks (treatment group B1), 
or to switch to ABP 710 (treatment group B2) every 8 weeks. Subjects initially randomized 
to ABP 710 (treatment group A) will continue on the same treatment. Re-randomization will 
be managed to ensure that the blind to the initial study group is maintained.  Subjects who 
are unable to complete the week 22 visit within the visit window of ± 3 days will be 
discontinued from the study. These subjects should return for an end-of-study visit 
to complete the end-of-study assessments within 28 days, if possible.
The last treatment for all subjects who do not discontinue early will be at week 46. 
Subjects will be considered study completers when they finish the week 50 end-of-study 
assessments. An independent data monitoring committee will evaluate the safety data 
throughout the study.
STUDY POPULATION AND MAIN CRITERIA FOR INCLUSION/EXCLUSION: Subjects
cannot be randomized before all entry criteria (including test results) are confirmed.
Inclusion Criteria:
1.
Subject has signed an institutional review board/independent ethicscommittee-
approved informed consent form before any study specific procedures are performed.
2.
Subject (man or woman) is ≥ 18 and ≤ 80 years old.

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 5 of 82
Confidential
3.
Subject is diagnosed with RA as determined by meeting the 2010 American College
of Rheumatology (ACR)/European League Against Rheumatism classification criteria 
for RA.
4.
Subject has RA duration of at least 3 months.
5.
Subject has active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints (based on 
66/68 joint count excluding distal interphalangeal joints) at screening and baseline 
and at least 1 of the following at screening:
-
erythrocyte sedimentation rate ≥ 28 mm/hr
-
serum C-reactive protein > 1.0 mg/dL
6.
Subject has at least one of the following: a positive rheumatoid
factor or anti-cyclic citrullinated peptide at screening.
7.
Subject has taken MTX for ≥12 consecutive weeks and is on a stable dose
of oral or subcutaneous MTX 7.5 to 25 mg/week for ≥ 8 weeks before receivingthe
investigational product and is willing to remain on a stable dose throughout the
study.
8.
For a subject on nonsteroidal anti-inflammatory drugs or low potency 
analgesics such as tramadol, Soma Compounds, Fioricet, or Fiorinal, the dose 
should be stable for ≥ 2 weeks before screening.
9.
For a subject on oral corticosteroids (≤10 mg prednisone or
equivalent), the dose should be stable for ≥ 4 weeks before screening.
10.
Subject has no known history of active tuberculosis.
Subject must meet any 1 of the following 3 criteria:
11.
Subject has a negative test for tuberculosis during screening defined as
either:
-
negative purified protein derivative (PPD) defined as < 5 mm of induration 
at 48 to 72 hours after test is placed
OR
-
negative Quantiferon test
12.
Subject with a positive PPD and a history of Bacillus Calmette-Guérin 
vaccination is allowed with a negative Quantiferon test.
13.
Subject with a positive PPD test (without a history of Bacillus Calmette-
Guérin vaccination) or a subject with a positive or indeterminate Quantiferon test is 
allowed if they have all of the following:
-
no symptoms of tuberculosis according to the worksheet provided by the 
sponsor, Amgen Inc. 
-
documented history of adequate prophylaxis initiation before receiving 
investigational product in accordance with local recommendations
-
no known exposure to a case of active tuberculosis after most recent 
prophylaxis
Exclusion Criteria:
Rheumatoid arthritis related

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 6 of 82
Confidential
1.
Subject has Class IV RA (Hochberg et al, 1992) according to the ACR 
revised response criteria.
2.
Subject has Felty’s syndrome (RA, splenomegaly, and granulocytopenia).
3.
Subject has a history of prosthetic or native joint infection.
Other medical conditions
4.
Subject has a planned surgical intervention during the duration of the 
study.
5.
Subject has an active infection or history of infections as follows:
-
any active infection for which systemic anti-infectives were used within 
28 days before first dose of investigational product
-
a serious infection, defined as requiring hospitalization or intravenous 
(IV) anti-infective(s) within 8 weeks before the first dose of investigational 
product
-
recurrent or chronic infections or other active infection that, in the 
opinion of the investigator, might cause this study to be detrimental to the 
subject
6.
Subject has a positive blood test for human immunodeficiency virus.
7.
Subject has a positive hepatitis B surface antigen, hepatitis B core 
antibody, or hepatitis C virus antibody result at screening.
8.
Subject has uncontrolled, clinically significant systemic disease such as 
diabetes mellitus, cardiovascular disease including moderate or severe heart 
failure (New York Heart Association Class III/IV), renal disease, liver disease, or 
hypertension.
9.
Subject had a malignancy within 5 years EXCEPT for treated and 
considered cured cutaneous squamous or basal cell carcinoma, in situ cervical 
cancer, OR in situ breast ductal carcinoma.
10.
Subject has a history of neurologic symptoms suggestive of central or 
peripheral nervous system demyelinating disease.
11.
Subject has a major chronic inflammatory disease or connective tissue 
disease other than RA, with the exception of secondary Sjögren’s syndrome.
12.
Subject has a concurrent medical condition that, in the opinion of the 
investigator, could cause this study to be detrimental to the subject.
Laboratory abnormalities
13.
Subject has laboratory abnormalities at screening, including any of the 
following:
-
hemoglobin < 9 g/dL
-
platelet count < 100 000/mm3
-
white blood cell count < 3000/mm3
-
aspartate aminotransferase and/or alanine aminotransferase ≥ 2.0 x 
the upper limit of normal
-
creatinine clearance < 50 mL/min (Cockroft-Gault formula)
-
any other laboratory abnormality, that, in the opinion of the 
investigator, will prevent the subject from completing the study or will interfere 
with the interpretation of the study results.
Washouts and nonpermitteddrugs
14.
Subject has used any of the following within 28 days before the first dose 
of investigational product:
-
intra-articular (IA) hyaluronic acid injections
-
intramuscular (IM), IA, or IV corticosteroids, including 
adrenocorticotropic hormone

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 7 of 82
Confidential
15.
Subject has used nonbiologic disease-modifying antirheumatic drugs other 
than MTX within 28 days before the first dose of investigational product, except as 
below:
-
leflunomide (unless an active washout with cholestyramine has been 
performed), cyclosporine, azathioprine, tacrolimus excluded within 3 months 
before the first dose of investigational product
-
intramuscular or oral gold excluded within 6 months before the first 
dose of investigational product
-
cytotoxic agents such as cyclophosphamide, D-penicillamine excluded 
within 6 months before the first dose of investigational product
-
intravenous gamma-globulin or Prosorba column therapy excluded 
within 3 months before the first dose of investigational product
-
Janus kinase inhibitor eg, tofacitinib; excluded within 28 days before 
the first dose of investigational product.
16.
Subject has prior use of 2 or more distinct biologic therapies for RA.
17.
Subject has used commercially available or investigational biologic 
therapies for RA as follows:
-
anakinra, etanercept within 1 month before the first dose of 
investigational product
-
abatacept, tocilizumab, adalimumab, golimumab, certolizumab within 
3 months before the first dose of investigational product
-
other experimental or commercially available biologic therapies for RA 
within 3 months or 5 half-lives (whichever is longer) before the first dose of 
investigational product
-
rituximab within 9 months before the investigational product along with 
evidence of incomplete B cell recovery
18.
Subject has received live vaccines within 28 days before the first dose of 
investigational product or plans to receive live vaccines during the course of the 
study.
19.
Subject has chronic use of high potency narcotic analgesics such as 
morphine or morphine-derived medications, fentanyl, codeine, hydromorphone, 
levorphanol, meperidine, methadone, oxycodone, or hydrocodone at screening.
20.
Subject who has taken any of the above agents in the past must have 
recovered from all drug-related adverse events.
21.
Subject has previously received Remicade® (infliximab) or a biosimilar of 
infliximab.
22.
Subject is currently enrolled in or has not yet completed at least 30 days 
or 5 half-lives (whichever is longer) since ending other investigational device or 
investigational drug(s), including vaccines, or subject is receiving other 
investigational agent(s).
General
23.
Woman who is pregnant or breast feeding, or plans to become pregnant 
while enrolled in the study and for 6 months after the last dose of investigational 
product.
24.
Woman who is of childbearing potential (ie, neither surgically sterile nor 
postmenopausal) and does not agree to use adequate contraception (eg, true 
abstinence, sterilization, birth control pills, Depo-Provera® [medroxyprogesterone] 
injections, contraceptive implants, or other effective methods) while on study 
and for 6 months after the last dose of investigational product.
25.
Subject has a known sensitivity to mammalian cell-derived drug products 
or hypersensitivity to the active substance or to any of the excipients of ABP 710 
or infliximab.

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Confidential
26.
Subject has any physical or psychiatric disorder that, in the opinion of the 
investigator, will prevent the subject from completing the study or will interfere with 
the interpretation of the study results.
27.
Subject has any disorder that compromises the ability of the subject to 
give written informed consent and/or to comply with study procedures.
28.
Subject has active substance abuse (within 24 weeks of screening).
180%(52)68%-(&76Approximately 550 subjects will be randomized in a 1:1 ratio
to receive either ABP 710 or infliximab. Subjects will be stratified based on geographic
region and prior biologic use for RA (with prior biologic use capped at 30% of the study
population). The sample size is chosen to achieve > 90% power to demonstrate
equivalence at a 0.05 significance level on the primary efficacy endpoint, response
difference (RD) of 20% improvement in ACR core set measurements (ACR20) at week 22
between ABP 710 and infliximab, with an equivalence margin of (-15%, 15%), assuming
an expected ACR20 rate for both ABP 710 and infliximab of 52% at week 22. This sample 
size will also achieve approximately 85% power to demonstrate equivalence on the RD of
ACR20 between ABP 710 and infliximab with an equivalence margin of (-12%, 15%) at a
significance level of 0.05 at week 22.
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ABP 710 (biosimilar candidate to infliximab) 3 mg/kg infusion given on day 1, weeks 2
and 6, and every 8 weeks thereafter
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response difference of ACR20 at week 22
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response difference of ACR20 at weeks 2, 6, 14, 30, 34, 38, 46, and 50
•
response difference of 50% improvement in ACR core set measurements (ACR50) 
and 70% improvement in ACR core set measurements (ACR70) at weeks 2, 6, 14, 
22, 30, 34, 38, 46, and 50
•
disease activity score in 28 joints - C-reactive protein (DAS28-CRP) change from 
baseline at weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50
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treatment-emergent adverse events, serious adverse events, and adverse events of 
special interest
•
clinically significant changes in laboratory values and vital signs
•
incidence of antidrug antibodies
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treat analysis set based on the subject’s randomized treatment. As a sensitivity analysis,
CCI

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 9 of 82
Confidential
the equivalence test on the primary endpoint will be also performed using the per-protocol
analysis set.
Clinical equivalence for the primary endpoint, RD of ACR20 at week 22, will be sequentially
evaluated: first by comparing the 2-sided 90% CI of the RD of ACR20 between ABP 710
and infliximab with an equivalence margin of (-15%, 15%). The CIs will be estimated from
the stratified Newcombe confidence limits for the common RD to adjust for stratification
factors.
If the first equivalence is established, the primary endpoint, RD of ACR20 at week
22 will be further evaluated by comparing the same 2-sided 90% CI between ABP 710 and
infliximab with an equivalence margin of (-12%, 15%). In addition to the 90% CI, the 95% 
CI for all primary and secondary efficacy endpoints will also be provided descriptively.
Inferential analyses will only be performed for the primary endpoint. Secondary efficacy 
endpoints, ACR20 at scheduled visits other than week 22, ACR50/ACR70, and DAS28-
CRP will be analyzed descriptively at various time points.
All safety analyses will be performed using the safety analysis set based on actual
treatment received. Safety analysis will include analyses of adverse events, clinical
laboratory test results, vital signs, and antidrug antibodies. In general, summaries will be
provided separately as follows: from day 1 (first investigational product administration) until
week 22, from week 22 through the end of the study, and for the entire study period (from
day 1 [first investigational product administration] through the end of the study).
The number and percentage of subjects developing binding antidrug antibodies and those 
developing neutralizing antidrug antibodies will be tabulated separately for day 1 until week
22, from week 22 through the end of the study, and for the entire study by actual treatment 
received.
DATE AND VERSION: 17 March 2017, version 2.0

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 10 of 82
Confidential
3
TABLE OF CONTENTS
1
TITLE PAGE.................................................................................................1
2
SYNOPSIS...................................................................................................4
3
TABLE OF CONTENTS .............................................................................10
4
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS.......................14
5
ETHICS.......................................................................................................17
5.1
Ethics Committee......................................................................................17
5.2
Ethical Conduct of the Study ...................................................................17
5.3
Subject Information and Consent............................................................17
6
INTRODUCTION ........................................................................................19
6.1
Disease Review.........................................................................................19
6.2
Infliximab...................................................................................................20
6.3
Compound Review....................................................................................20
6.4
Study Rationale.........................................................................................22
7
STUDY OBJECTIVES ................................................................................23
7.1
Primary Study Objective...........................................................................23
7.2
Secondary Study Objectives....................................................................23
8
INVESTIGATIONAL PLAN.........................................................................24
8.1
Overall Study Design and Plan ................................................................24
8.2
Discussion of Study Design...................................................................25
8.3
Study Duration ..........................................................................................25
8.4
Study Population ......................................................................................26
8.4.1
Inclusion Criteria .........................................................................................26
8.4.2
Exclusion Criteria........................................................................................27
8.4.3
Withdrawal and Replacement of Subjects...................................................30
8.5
Treatments ................................................................................................32
8.5.1
Treatments Administered ............................................................................32
8.5.2
Study Treatment Formulation......................................................................33
8.5.3
Study Treatment Labeling and Packaging...................................................34
8.5.4
Blinding of Study Medication.......................................................................34
8.5.5
Study Treatment Storage and Accountability ..............................................35
8.5.6
Dose Adjustments and Dose Escalation......................................................36
8.5.7
Prior and Concomitant Therapy ..................................................................36
8.5.8
Treatment Compliance................................................................................38
8.5.9
Assignment to Treatment ............................................................................38
8.5.10
Unblinding Procedures................................................................................39
8.6
Efficacy and Safety Variables...................................................................39
8.6.1
Efficacy and Safety Measurements Assessed.............................................39
9
STUDY EVALUATIONS BY VISIT..............................................................44

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 11 of 82
Confidential
9.1
Screening ..................................................................................................44
9.1.1
Screen Failures...........................................................................................45
9.2
Baseline (Day 1, first day of treatment, Week 0) .....................................45
9.3
Week 2 (2 days), Week 6 (3 days), and Week 14 (3 days) ..............46
9.4
Week 22 (3 days) ....................................................................................47
9.5
Week 30 (5 days) ....................................................................................48
9.6
Week 34 (5 days) ....................................................................................49
9.7
Weeks 38 and 46 (5 days) ......................................................................50
9.8
Week 50/End-of-Study (5 days).............................................................51
10
METHODS OF ASSESSMENT...................................................................52
10.1
Efficacy Assessments ..............................................................................52
10.2
Safety Assessments .................................................................................52
10.2.1
Pregnancy Test...........................................................................................52
10.2.2
Physical Examination..................................................................................53
10.2.3
Vital Signs...................................................................................................53
10.2.4
Electrocardiogram.......................................................................................53
10.2.5
Tuberculosis Testing...................................................................................54
10.2.6
Chest Radiography .....................................................................................54
10.3
Clinical Laboratory Testing ......................................................................54
10.4
Pharmacokinetic Analysis........................................................................55
11
SAFETY DATA COLLECTION, RECORDING, AND REPORTING............56
11.1
Adverse Events.........................................................................................56
11.1.1
Definition of Adverse Events .......................................................................56
11.1.2
Reporting Procedures for Adverse Events ..................................................56
11.2
Serious Adverse Events ...........................................................................57
11.2.1
Definition of Serious Adverse Events ..........................................................57
11.2.2
Reporting Procedures for Serious Adverse Events .....................................58
11.3
Adverse Events of Special Interest..........................................................60
11.4
Pregnancy Reporting................................................................................60
12
DATA MANAGEMENT AND STATISTICAL ANALYSIS............................61
12.1
Data Management .....................................................................................61
12.2
Sample Size Estimation............................................................................61
12.3
Statistical Analysis Plan...........................................................................61
12.4
Randomization ..........................................................................................61
12.5
Analysis Sets.............................................................................................62
12.5.1
Intention-to-treat Analysis Set .....................................................................62
12.5.2
Per-protocol Analysis Set............................................................................62
12.5.3
Safety Analysis Set .....................................................................................62
12.6
Statistical Methods ...................................................................................63

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 12 of 82
Confidential
12.6.1
Missing Data...............................................................................................63
12.6.2
Demographic and Baseline Data.................................................................63
12.6.3
Subject Disposition .....................................................................................63
12.6.4
Efficacy .......................................................................................................64
12.6.5
Safety .........................................................................................................64
12.6.6
Pharmacokinetics........................................................................................66
12.6.7
Primary Analysis .........................................................................................66
12.6.8
Data Monitoring Committee.........................................................................66
13
MONITORING PROCEDURES (QUALITY ASSURANCE).........................67
13.1
Routine Monitoring ...................................................................................67
13.2
Inspections and Auditing Procedures.....................................................67
14
STUDY MANAGEMENT AND MATERIALS...............................................69
14.1
Electronic Case Report Forms.................................................................69
14.2
Data Collection..........................................................................................69
14.3
Source Documents Maintenance.............................................................70
14.4
Record Maintenance.................................................................................70
14.5
Confidentiality...........................................................................................72
15
ADMINISTRATION PROCEDURES ........................................................73
15.1
Regulatory Approval ...............................................................................73
15.2
Protocol Amendments..............................................................................73
15.3
Protocol Adherence and Deviations........................................................74
15.4
Publication Policy.....................................................................................74
15.5
Clinical Study Report ..............................................................................75
15.6
Contractual and Financial Details............................................................75
15.7
Compensation...........................................................................................75
15.8
Discontinuation of the Study ...................................................................75
15.9
Study Center File Management................................................................75
16
REFERENCE LIST .....................................................................................77
17
APPENDICES.............................................................................................79
17.1
Appendix 1: Elements of Informed Consent ...........................................79
17.2
Appendix 2: American College of Rheumatology Revised Criteria for 
the Classification of Functional Capacity in RA .....................................80
17.3
Appendix 3: American College of Rheumatology Core Set 
Measurements...........................................................................................81
17.4
Appendix 4: Subjective Assessment Scales .......................................82

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LIST OF TABLES
Table 8-1.  Schedule of Assessments and Procedures ............................................40
LIST OF FIGURES
Figure 8-1.  StudyDiagram..........................................................................................25

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4
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
Term
Definition
ACR
American College of Rheumatology
ACR20
20% improvement in ACR core set measurements
ACR50
50% improvement in ACR core set measurements
ACR70
70% improvement in ACR core set measurements
ALT
alanine aminotransferase
AST
aspartate aminotransferase
CCP
cyclic citrullinated peptide
CFR
Code of Federal Regulations
CI
confidence interval
COX-2
cyclooxygenase-2
CRO
clinical research organization
CRP
C-reactive protein
CTCAE
Common Terminology Criteria for Adverse Events
DAS
disease activity score
DAS28
disease activity score in 28 joints
DAS28-CRP
disease activity score in 28 joints - C-reactive protein 
DMARD
disease-modifying antirheumatic drug
DMC
Data Monitoring Committee
ECG
electrocardiogram
eCRF
electronic case report form
EDC
electronic data capture
ESR
erythrocyte sedimentation rate
EU
European Union
Fc
fragment crystallizable

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FDA
Food and Drug Administration
GCP
Good Clinical Practice
HAQ-DI
Health Assessment Questionnaire - Disability Index
HBsAg
hepatitis B surface antigen
HCV
hepatitis C virus
IA
intra-articular
IB
investigator’s brochure
ICF
informed consent form
ICH
International Council for Harmonisation
IEC
independent ethics committee
Infliximab
US-licensed infliximab
IL
interleukin
IL-1
interleukin-1
IL-1β
interleukin-1 beta
IL-6
interleukin-6
IL-8
interleukin-8
IM
intramuscular
IRB
institutional review board
IV
intravenous(ly)
IXRS
interactive voice and web response system 
MedDRA
Medical Dictionary for Regulatory Activities
MMP
matrix metalloproteinase
MTX
methotrexate
NSAID
nonsteroidal anti-inflammatory drug
PIN
Personal Identification Number
PPD
purified protein derivative

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RA
rheumatoid arthritis
RD
response difference
SAP
statistical analysis plan
SJC
swollen joint count
SUSAR
suspected unexpected serious adverse reactions
TJC
tender joint count
TNFα
tumor necrosis factor alpha
US
United States
VAS
visual analogue scale
WHO-DD
World Health Organization-Drug Dictionary

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5
ETHICS
5.1
Ethics Committee
This study will be conducted in compliance with institutional review board 
(IRB)/independent ethics committee (IEC) and International Council for Harmonisation 
(ICH) Good Clinical Practice (GCP) Guidelines including Title 21 Part 56 of the United 
States (US) Code of Federal Regulations (CFR) relating to IRBs/IECs and GCP as 
described in the US Food and Drug Administration (FDA) CFR (21 CFR § 50, 56, 312) in 
accordance with applicable ICH regulations regarding clinical safety data management 
(E2A, E2B[R3]), European Union (EU) Community Directives 2001/20, 2001/83, 2003/94 
and 2005/28 as enacted into local law, and with ICH guidelines regarding scientific 
integrity (E4, E8, E9, and E10). In addition, this study will adhere to all local regulatory 
requirements and requirements for data protection.
Before initiating a trial/study, the investigator/institution must have written and dated 
approval/favorable opinion from the IRB/IEC for the study protocol/amendment(s), 
written informed consent form (ICF), any consent form updates, subject recruitment 
procedures (eg, advertisements), and any written information to be provided to subjects, 
and a statement from the IRB/IEC that they comply with GCP requirements. The 
IRB/IEC approval must identify the protocol version as well as the documents reviewed.
5.2
Ethical Conduct of the Study
This study will be conducted in accordance with the Note for Guidance on GCP (ICH 
Harmonised Tripartite Guideline E6 [R1]; FDA CFR [21 CFR § 50, 56, 312]) and all 
applicable regulatory requirements.
5.3
Subject Information and Consent
The investigator will explain the benefits and risks of participation in the study to each 
subject or the subject’s legally acceptable representative and obtain written informed 
consent. Written informed consent must be obtained prior to the subject entering the 
study and before initiation of any study-related procedure (including administration of 
investigational product).
The sponsor will provide a sample ICF, based on the elements of informed consent in 
Section 17.1. The final, version-dated form must be agreed to by the sponsor and the 
IRB/IEC and will contain all elements in the sample form, in language readily understood 
by the subject. Each subject’s original consent form (personally signed and dated by the

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subject or by the subject’s legally acceptable representative and by the person who 
conducted the informed consent discussion) will be retained by the investigator. The 
investigator will supply all enrolled subjects with a copy of their signed ICF.
The ICF may need to be revised during the study should important new information 
become available that may be relevant to the safety of the subject. In this instance, 
approval should always be given by the IRB/IEC, and existing subjects will need to be 
informed of the changes and be re-consented. This is documented in the same way as 
previously described.
The investigator should, with the consent of the subject, inform the subject’s primary 
physician about the subject’s participation in the clinical study as needed.

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6
INTRODUCTION
6.1
Disease Review
Rheumatoid arthritis (RA) is a chronic inflammatory disease of unknown etiology in 
which patients exhibit systemic features such as fatigue, low-grade fever, weight loss, 
anemia, and increased systemic measures of acute phase reactants (eg, erythrocyte
sedimentation rates [ESRs] and C-reactive protein [CRP]; Aletaha et al, 2010). Although 
the disease is systemic in nature, the primary target tissues are the synovial membrane, 
cartilage, and bone (McInnes and Schett, 2007), which exhibit uncontrolled 
synovium/pannus proliferation and excess fluid production, and ultimately undergo 
progressive destructive arthropathy (Aletaha et al, 2010; Choy and Panayi, 2001).
The destruction of the cartilage seen in RA, and related inflammatory diseases, is 
considered to be due to the activity of matrix metalloproteinases (MMPs) that are 
produced by resident and infiltrating cells in inflamed synovium (Feldmann M et al, 
1996).
Tumor necrosis factor alpha (TNFα), in conjunction with interleukin (IL)-1, plays a key 
role in synovial inflammation by increasing expression of endothelial-cell adhesion 
molecules, which cause retention of lymphocytes in the affected joint (Chin JE et al, 
1990). Tumor necrosis factor alpha promotes joint damage by increasing the release of 
MMPs, particularly MMP-3 (Carrasco R et al, 2010), involved in the breakdown of the 
connective tissue matrix and by decreasing production of tissue inhibitor of 
metalloproteinase (Shingu M et al, 1993). Tumor necrosis factor alpha also has a role in 
the bone damage seen in RA, by promoting development of osteoclasts, either directly 
through tumor necrosis factor receptor 1 or indirectly through additive effects with 
receptor activator of nuclear factor-KB ligand (McInnes and Schett, 2007).
In an in vitro study conducted with synovial tissue isolated and cultured from the joints of 
patients with RA (thus containing a mixture of synovial cell types, eg, macrophages, 
T cells, fibroblasts, endothelial cells, and plasma cells), blockage of TNFα diminished the 
production of proinflammatory cytokines interleukin-1 beta (IL-1β), interleukin -6 (IL-6),
and interleukin-8 (IL-8), and granulocyte- macrophage colony-stimulating factor, 
suggesting that TNFα can modulate proinflammatory cytokine production within the local 
synovial environment (Butler DM et al, 1995). Conversely, blocking interleukin-1 (IL-1)
activity had no effect on TNFα concentrations, indicating that IL-1 was not solely 
involved in regulating TNFα production in RA (Butler DM et al, 1995).

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Angiogenesis and increased expression of endothelial molecules are also prominent 
features in RA, as they are in other chronic inflammatory disorders. This is manifested 
by increased blood vessel density, facilitating cell trafficking in and out of the inflamed 
tissue (Tracey D et al, 2008).
6.2
Infliximab
Remicade® (infliximab) is a chimeric human-murine monoclonal antibody that binds with 
high affinity to both soluble and transmembrane forms of TNFα, but not to lymphotoxin α 
(REMICADE Prescribing Information). Elevated concentrations of TNFα have been
found in the joints of patients with RA and correlate with elevated disease activity. In 
RA, treatment with infliximab reduced infiltration of inflammatory cells into inflamed areas 
of the joint, as well as reduced expression of molecules mediating cellular adhesion,
chemo-attraction, and tissue degradation. After infliximab treatment, patients with RA 
exhibited decreased concentrations of serum IL-6 and CRP; and patients with reduced 
hemoglobin concentrations had increased hemoglobin concentrations compared with 
baseline. Peripheral blood lymphocytes showed no significant decrease in number or in 
proliferative responses to in vitro mitogenic stimulation when compared with untreated 
patients’ cells.
Infliximab, in combination with methotrexate (MTX), is indicated for the reduction of signs 
and symptoms of RA, as well as the improvement in physical function in adult patients 
with active disease when the response to disease-modifying antirheumatic drugs 
(DMARDs), including MTX, has been inadequate and in adult patients with severe,
active and progressive disease not previously treated with MTX or other DMARDs 
(REMICADE Prescribing Information).
6.3
Compound Review
ABP 710 is being developed as a biosimilar candidate to Remicade® (infliximab) for the 
treatment of RA and other indications: Crohn’s disease (adults/pediatrics), ulcerative 
colitis (adults/pediatrics), ankylosing spondylitis (adults), psoriatic arthritis (adults), and 
plaque psoriasis (adults). The active ingredient of ABP 710 is a monoclonal antibody 
that has the same amino acid sequence as infliximab. ABP 710 has the same 
pharmaceutical form and dosage strength as infliximab.
Similarity of ABP 710 to infliximab has been shown in analytical assessments. ABP 710 
and infliximab have similar binding affinity for human TNFα and comparable inhibition of 
TNFα as assessed in vitro in the human histiocytic lymphoma cell line U-937. ABP 710

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and infliximab also show similar in vitro binding to the fragment crystallizable (Fc) 
neonatal receptor and Fc gamma receptor Type IIIa, and similar antibody-dependent 
cell-mediated cytotoxicity and complement-dependent cytotoxicity activity in vitro. In a 
toxicology study in rats, administration of ABP 710 or infliximab was similarly well 
tolerated at doses of up to 50 mg/kg for 2 weeks. In the absence of pharmacologically 
relevant preclinical species to evaluate on-target effects in vivo, ABP 710 and infliximab 
demonstrated a similar lack of activity in an in vitro cytokine release assay with human 
peripheral blood leukocytes and endothelial cells. Refer to the investigator’s brochure 
(IB) for additional information about ABP 710 and its comparability with infliximab.
 
 
 
 
 
 
 
 
 
Adverse events that may be serious or fatal include serious infections including new 
onset or reactivation of tuberculosis, reactivation of hepatitis B, sepsis, malignancies 
including lymphomas (such as hepatosplenic T-cell lymphoma), serious infusion 
reactions including delayed K\SHUVHQVLWLYLW\, hepatotoxicity, heart failure, hematologic 
reactions, and demyelinating disorders. Based on clinical trial experience in infliximab-
treated adult subjects across multiple indications, frequently reported (≥10% subject 
incidence) adverse reactions included viral infections, headache, upper respiratory tract 
infection, sinusitis, abdominal pain, nausea, infusion-related reaction, and pain. Based 
on clinical trial experience in subjects with RA, the most common (≥10% subject 
incidence) adverse reactions in those receiving 4 or more infusions of infliximab were 
nausea, abdominal pain, diarrhea, dyspepsia, upper respiratory tract infection, sinusitis, 
pharyngitis, coughing, bronchitis, rash, and headache (ABP 710 Investigator’s Brochure, 
Edition 3, 17 Mar 2016).
CCI

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6.4
Study Rationale
In the US, EU, and much of the world, laws, regulations, and guidances have been or 
are being put in place to increase availability of biological treatments by developing and 
licensing biosimilar products (EMA/CHMP/437/04 Rev 1; 
EMA/CHMP/BWP/247713/2012 Rev 1; EMEA/CHMP/BMWP/42832/2005 Rev.1; 
EMEA/CHMP/BMWP/403543/2010 Rev. 1; US FDA 2015a; US FDA 2015b). A
biosimilar product, generally, is highly similar to a licensed biologic reference product, 
and there are no clinically meaningful differences between the biosimilar and reference 
products in terms of safety, purity, and potency. Biosimilarity is demonstrated by the 
totality of the evidence, including analytical, nonclinical, and clinical evidence. The 
analytical and pharmacokinetic similarity of ABP 710 and infliximab are summarized 
briefly in more detail in the IB.
A phase 1 study of ABP 710 compared with infliximab (US) and infliximab (EU) (Study 
20140108) was conducted in 148 healthy adult men and women. Subjects received a 
single 5 mg/kg IV infusion of ABP 710, infliximab (US), or infliximab (EU), and were 
followed for 57 days after infusion. A similar safety profile was seen across the
3 treatment groups. Overall, all treatments were safe and well tolerated. The most 
common treatment-emergent adverse events were somnolence (53.4%), headache 
(31.8%), nasopharyngitis (8.8%), upper respiratory tract infection (4.7%), and nausea 
(4.2%).  The percentage of subjects who were positive for binding antibodies was 
42.9%, 36.0% and 32.7% for ABP 710, infliximab (US) and infliximab (EU), respectively. 
Thus, it is expected that the safety profile of ABP 710 is similar to that of infliximab.
The current study is designed to demonstrate the clinical similarity between ABP 710 
and infliximab in terms of efficacy, safety, and immunogenicity for moderate and severe 
RA and in accordance with the biosimilar regulations and guidance (EMA/CHMP/437/04 
Rev.1; EMA/CHMP/BWP/247713/2012 Rev 1; EMEA/CHMP/BMWP/42832/2005 Rev.1; 
EMEA/CHMP/BMWP/403543/2010 Rev 1; US FDA 2015a; US FDA 2015b).

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7
STUDY OBJECTIVES
7.1
Primary Study Objective
The primary objective for this study is to assess the efficacy of ABP 710 compared with 
US-licensed infliximab (infliximab).
7.2
Secondary Study Objectives
The secondary objectives are to assess the safety and immunogenicity of ABP 710 
compared with infliximab.

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8
INVESTIGATIONAL PLAN
8.1
Overall Study Design and Plan
This is a randomized, double-blind, active-controlled study in adult subjects with 
moderate to severe RA who have an inadequate response to MTX. Approximately 
550 subjects (275 per treatment group) will be enrolled. The subjects will be randomized 
in a 1:1 ratio to receive either ABP 710 3 mg/kg infusion on day 1, at weeks 2 and 6, and 
every 8 weeks thereafter (treatment group A), or infliximab 3 mg/kg infusion on day 1, at 
weeks 2 and 6, and every 8 weeks thereafter (treatment group B), until week 22.
At week 22, subjects initially randomized to the infliximab group will be re-randomized in 
a 1:1 ratio to either continue receiving infliximab infusion every 8 weeks (treatment group 
B1), or to switch to ABP 710 (treatment group B2).  Subjects initially randomized to 
ABP 710 (treatment group A) will continue on the same treatment. Re-randomization 
will be managed to ensure that the blind to the initial study group is maintained.  
Subjects who are unable to complete the week 22 visit within the visit window 
of ± 3 days will be discontinued from the study.  These subjects should return 
for an end of study visit to complete the end-of-study assessments within 28 
days, if possible. The last treatment for all subjects who do not discontinue early will 
be at week 46. Subjects will be considered study completers when they finish the week 
50 end-of-study assessments.
Subjects will complete a screening period of up to 4 weeks, receive investigational 
product for 46 weeks, and complete an efficacy, safety, and immunogenicity follow-up 
period of 4 weeks for a total study duration of up to 54 weeks.
An independent data monitoring committee (DMC) will evaluate the safety data 
throughout the study. The primary analysis will be conducted at week 34. The end of 
the study will be at week 50, and a final analysis will be conducted when all subjects 
have completed the week 50/end-of-study assessments (or are terminated early from 
the study).  Study completion is defined as completion of the week 50 visit.
Figure 8-1 is a summary of the study design.

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Figure 8-1.  StudyDiagram
e8W = every 8 weeks; EOS = end-of-study (week 50); EOT = end-of-treatment (week 46).
Note: the primary analysis will be conducted at week 34.
8.2
Discussion of Study Design
This study is randomized and double-blinded to prevent bias in treatment allocation and 
in the subjective assessment of effect. The primary analysis will be conducted after all 
subjects have either completed the week 34 assessments, or been terminated from the 
study before week 34.
8.3
Study Duration
The study consists of a screening period of up to 4 weeks, a treatment period of 46 
weeks, and a safety, immunogenicity, and efficacy follow-up period through to week 50 
for a total of up to 54 weeks.
Enrollment will continue until approximately 550 subjects (275 per treatment group) have 
been randomized to treatment. The end of the study will be the date when the last 
subject has completed the last study assessment.

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8.4
Study Population
8.4.1
Inclusion Criteria
Subjects MUST satisfy all of the following entry criteria before they will be allowed to
participate in the study:
1. Subject has signed an IRB/IEC-approved ICF before any study-specific
procedures are performed.
2. Subject (man or woman) is ≥ 18 and ≤ 80 years old.
3. Subject is diagnosed with RA as determined by meeting the 2010 American
College of Rheumatology (ACR)/European League Against Rheumatism
classification criteria for RA.
4. Subject has RA duration of at least 3 months.
5. Subject has active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints
(based on 66/68 joint count, excluding distal interphalangeal joints) at 
screening and baseline and at least 1 of the following at screening:
-
erythrocyte sedimentation rate ≥ 28 mm/hr
-
serum CRP > 1.0 mg/dL
6. Subject has at least one of the following: a positive rheumatoid factor or anti-
cyclic citrullinated peptide (CCP) at screening.
7. Subject has taken MTX for ≥ 12 consecutive weeks and is on a stable dose of
oral or subcutaneous MTX 7.5 to 25 mg/week for ≥ 8 weeks before receiving
the investigational product and is willing to remain on a stable dose throughout
the study.
8. For a subject on nonsteroidal anti-inflammatory drugs (NSAIDs) or low potency 
analgesics such as tramadol, Soma Compounds, Fioricet, or Fiorinal, the dose
should be stable for ≥ 2 weeks before screening.
9. For a subject on oral corticosteroids (≤ 10 mg prednisone or equivalent), the
dose should be stable for ≥ 4 weeks before screening.
10. Subject has no known history of active tuberculosis.
Subject must meet any 1 of the following 3 criteria:
11. Subject has a negative test for tuberculosis during screening defined as either:
-
negative purified protein derivative (PPD) defined as < 5 mm of 
induration at 48 to 72 hours after test is placed
OR

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-
negative Quantiferon test
12. Subject with a positive PPD and a history of Bacillus Calmette-Guérin 
vaccination is allowed with a negative Quantiferon test.
13. Subject with a positive PPD test (without a history of Bacillus Calmette-Guérin 
vaccination) or a subject with a positive or indeterminate Quantiferon test is 
allowed if they have all of the following:
-
no symptoms of tuberculosis according to the worksheet provided by
the sponsor, Amgen Inc.
-
documented history of adequate prophylaxis initiation before receiving
investigational product in accordance with local recommendations
-
no known exposure to a case of active tuberculosis after most recent 
prophylaxis
8.4.2
Exclusion Criteria
If any of the following apply, the subject MUST NOT enter the study:
Rheumatoid arthritis related
1. Subject has Class IV RA (Hochberg et al, 1992) according to the ACR revised 
response criteria (Section 17.2).
2. Subjects has Felty’s syndrome (RA, splenomegaly, and granulocytopenia).
3. Subject has a history of prosthetic or native joint infection.
Other medical conditions
4. Subject has a planned surgical intervention during the duration of the study.
5. Subject has an active infection or history of infections as follows:
-
any active infection for which systemic anti-infective(s) were used
within 28 days before the first dose of investigational product
-
a serious infection, defined as requiring hospitalization or IV anti-
infective(s) within 8 weeks before the first dose of investigational
product
-
recurrent or chronic infections or other active infection that, in the 
opinion of the investigator, might cause this study to be 
detrimental to the subject
6. Subject has a positive blood test for human immunodeficiency virus.
7. Subject has a positive hepatitis B surface antigen (HBsAg), hepatitis B core
antibody, or hepatitis C virus (HCV) antibody result at screening.

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8. Subject has uncontrolled, clinically significant systemic disease such as
diabetes mellitus, cardiovascular disease, including moderate or severe heart 
failure (New York Heart Association Class III/IV), renal disease, liver disease, 
or hypertension.
9. Subject had a malignancy within 5 years EXCEPT for treated and considered
cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR
in situ breast ductal carcinoma.
10. Subject has a history of neurologic symptoms suggestive of central or
peripheral nervous system demyelinating disease.
11. Subject has a major chronic inflammatory disease or connective tissue disease
other than RA, with the exception of secondary Sjögren’s syndrome.
12. Subject has a concurrent medical condition that, in the opinion of the
investigator, could cause this study to be detrimental to the subject.
Laboratory abnormalities
13. Subject has laboratory abnormalities at screening, including any of the
following:
-
hemoglobin < 9 g/dL
-
platelet count < 100 000/mm3
-
white blood cell count < 3000/mm3
-
aspartate aminotransferase (AST) and/or alanine 
aminotransferase (ALT) ≥2.0 x the upper limit of normal
-
creatinine clearance < 50 mL/min (Cockroft-Gault formula)
-
any other laboratory abnormality, that, in the opinion of the
investigator, will prevent the subject from completing the study or 
will interfere with the interpretation of the study results
Washouts and nonpermitted drugs
14. Subject has used any of the following within 28 days before the first dose of
investigational product:
-
intra-articular (IA) hyaluronic acid injections
-
intramuscular (IM), IA, or IV corticosteroids, including 
adrenocorticotropic hormone
15. Subject has used nonbiologic DMARDs other than MTX within 28 days before
the first dose of investigational product, except as below:

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-
leflunomide (unless an active washout with cholestyramine has
been performed), cyclosporine, azathioprine, tacrolimus excluded 
within 3 months before the first dose of investigational product
-
intramuscular or oral gold excluded within 6 months before the first 
dose of investigational product
-
cytotoxic agents such as cyclophosphamide, D-penicillamine 
excluded within 6 months before the first dose of investigational
product
-
intravenous gamma-globulin or Prosorba column therapy excluded
within 3 months before the first dose of investigational product
-
Janus kinase inhibitor, eg, tofacitinib; excluded within 28 days
before the first dose of investigational product
16. Subject has prior use of 2 or more distinct biologic therapies for RA.
17. Subject has used commercially available or investigational biologic therapies
for RA as follows:
-
anakinra, etanercept within 1 month before the first dose of
investigational product
-
abatacept, tocilizumab, adalimumab, golimumab, certolizumab
within 3 months before the first dose of investigational product
-
other experimental or commercially available biologic therapies for 
RA within 3 months or 5 half-lives (whichever is longer) before the 
first dose of investigational product
-
rituximab within 9 months before the investigational product along
with evidence of incomplete B cell recovery.
18. Subject has received live vaccines within 28 days before the first dose of
investigational product or plans to receive live vaccines during the course of the
study.
19. Subject has chronic use of high potency narcotic analgesics such as morphine
or morphine-derived medications, fentanyl, codeine, hydromorphone,
levorphanol, meperidine, methadone, oxycodone, or hydrocodone at screening.
20. Subject who has taken any of the above agents in the past must have
recovered from all drug-related adverse events.
21. Subject has previously taken Remicade® (infliximab) or a biosimilar of
infliximab.

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22. Subject is currently enrolled in or has not yet completed at least 30 days or
5 half-lives (whichever is longer) since ending other investigational device or 
investigational drug(s), including vaccines, or subject is receiving other 
investigational agent(s).
General
23. Woman who is pregnant or breast feeding, or plans to become pregnant while
enrolled in the study and for 6 months after the last dose of investigational
product.
24. Woman who is of childbearing potential (ie, neither surgically sterile nor
postmenopausal) and who does not agree to use adequate contraception (eg,
true abstinence, sterilization, birth control pills, Depo-Provera®
(medroxyprogesterone) injections, contraceptive implants, or other effective 
methods) while on study and for 6 months after the last dose of investigational
product.
25. Subject has a known sensitivity to mammalian cell-derived drug products or
hypersensitivity to the active substance or to any of the excipients of ABP 710
or infliximab.
26. Subject has any physical or psychiatric disorder that, in the opinion of the
investigator, will prevent the subject from completing the study or will interfere
with the interpretation of the study results.
27. Subject has any disorder that compromises the ability of the subject to give
written informed consent and/or to comply with study procedures.
28. Subject has active substance abuse (within 24 weeks of screening).
8.4.3
Withdrawal and Replacement of Subjects
8.4.3.1
Criteria for Subject Withdrawal
Subjects have the right to withdraw from the study at any time and for any reason 
without prejudice to future medical care by the physician or at the institution.
Subjects (or a legally acceptable representative) can decline to continue receiving 
investigational product and/or other protocol-required therapies or procedures at any 
time during the study, but continue participating in the study. If this occurs, the 
investigator is to discuss with the subject the appropriate processes for discontinuation 
from investigational product or other protocol-required therapies and must discuss with 
the subject the options for continuation of the Schedule of Assessments and Procedures 
(Table 8-1) and collection of data, including endpoints and adverse events. The 
investigator must document the change to the Schedule of Assessments and 

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Procedures (Table 8-1) and the level of follow-up that is agreed to by the subject (eg, in 
person, by telephone/mail, through family/friends, in correspondence/communication 
with other physicians, from review of the medical records).
Withdrawal of consent for a study means that the subject does not wish to receive 
further protocol-required therapies or procedures, and the subject does not wish to or is 
unable to continue further study participation. Subject data up to withdrawal of consent 
will be included in the analysis of the study and, where permitted, publically available 
data can be included after withdrawal of consent. The investigator is to discuss with the 
subject appropriate procedures for withdrawal from the study.
Reasons for removal from protocol-required investigational products or procedural 
assessments might include:

inability to complete the week 22 visit within the allowed visit window 

subject request to end investigational product administration

safety concern (eg, an adverse event, failure to follow contraception, and/or 
protocol requirements)

pregnancy
Subjects who discontinued treatment because of inability to complete the week 22 
visit within the allowed visit window should return for an end-of-study visit to 
complete the end-of-study assessments within 28 days, if possible.
Reasons for removal of a subject from the study might include:

withdrawal of consent from study

lost to follow-up

decision by sponsor
8.4.3.2
Evaluations at Withdrawal
For any subject who is withdrawn before completing all study visits, the investigator 
should:

Perform all the procedures scheduled for the week 50/end-of-study visit. 
These assessments will be performed no later than 28 days after 
withdrawal/discontinuation (unless the subject withdraws consent to do so).

Complete all appropriate electronic case report form (eCRF) screens, 
providing the date of and explanation for the subject’s 
withdrawal/discontinuation.

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 32 of 82
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
When indicated, arrange for appropriate follow-up and/or alternative 
medical care for the discontinued subject.
If the subject fails to attend a scheduled termination or follow-up visit, there will be at 
least 2 attempts to contact the subject via telephone and 2 written communications. If 
these receive no reply, the subject will be considered lost to follow-up.
8.4.3.3
Replacement of Subjects
Subjects who are withdrawn will not be replaced. However, a sufficient number of 
subjects will be included to ensure that the minimum defined sample size is reached 
(see Section 12.2).
8.5
Treatments
8.5.1
Treatments Administered
The investigator must ensure that the investigational products will be used only in 
accordance with the protocol.
ABP 710 is a chimeric human/murine monoclonal antibody with the same amino acid 
sequence as infliximab.
Subjects will initially be randomly assigned at baseline (day 1) to 1 of 2 treatment 
groups, as follows:

treatment A: ABP 710, 3 mg/kg IV infusion

treatment B: Infliximab, 3 mg/kg IV infusion
In both treatment groups, doses will be administered by study center staff on day 1, 
weeks 2 and 6, and then every 8 weeks thereafter until week 22. At week 22, subjects 
initially randomized to the infliximab group will be re-randomized in a 1:1 ratio to either 
continue receiving infliximab infusion every 8 weeks (treatment group B1), or switch to 
ABP 710 (treatment group B2) every 8 weeks. Subjects initially randomized to ABP 710 
will continue on the same treatment.
No dose reductions or changes will be allowed, except for weight-based dosing 
changes.
Premedications must be given.  Premedications should be selected according to local 
practice and/or the approved product label for infliximab. These medications should 
generally include acetaminophen and an antihistamine and methylprednisone 100 mg IV 

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 33 of 82
Confidential
or equivalent approximately 30 minutes before each infusion but should be selected 
according to the individual subject’s needs.
Intravenous infusions should be performed according to local practice and the approved 
product label for infliximab.
Investigational product infusion reactions should be handled according to local practice 
and the approved product label for infliximab.
ABP 710/infliximab will be administered after all other procedures have been completed 
for each visit. If the subject presents with an infection at the dosing visit(s), the 
administration of investigational product may be delayed (up to 5 days). If a dose is 
delayed or missed for any reason, subsequent doses should be administered at the 
original scheduled dosing dates in relation to the first dose date.
All subjects will continue on a stable dose of MTX (7.5 to 25 mg/week, oral, or 
subcutaneous) for the duration of their participation in the study, as prescribed by the 
treating physician. When possible, the dose of MTX should be taken on the same day of 
the week. In the event that a subject develops MTX-related side effects (eg, 
mucositis/stomatitis), a dose reduction or change of route should be considered, as 
deemed appropriate by the investigator. Please see Section 8.5.7.4 for folate/folinic 
acid.
8.5.2
Study Treatment Formulation
8.5.2.1
Study Drug
ABP 710 is a human/murine chimeric monoclonal IgG1 antibody that binds with high 
affinity to both soluble and transmembrane forms of TNFα and has the same amino acid 
sequence as infliximab. ABP 710 and infliximab are manufactured by recombinant DNA 
technology, and ABP 710 is expressed in a Chinese hamster ovary cell line and purified 
by a suitable process.
ABP 710 is supplied as a sterile, white, lyophilized powder for IV infusion requiring 
reconstitution prior to infusion with 10 mL of Sterile Water for injection. Each single-use
vial contains 100 mg ABP 710, 500 mg sucrose, 0.5 mg polysorbate 80, 2.2 mg 
monobasic sodium phosphate, monohydrate, and 6.1 mg dibasic sodium phosphate, 
dihydrate.

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Infliximab, the active ingredient in Remicade®, is a chimeric IgG1 kappa monoclonal 
antibody (composed of human constant and murine variable regions) specific for human 
TNFα. It has a molecular weight of approximately 149.1 kD and a binding affinity for 
soluble TNFα of approximately K(D)=4.2 picomolars, as measured by KinExA 
technology. Infliximab is produced by a recombinant cell line cultured by continuous 
perfusion and is purified by a series of steps that includes measures to inactivate and 
remove viruses.
Infliximab is supplied as a sterile, white, lyophilized powder for IV infusion. After 
reconstitution with 
mL Sterile Water for Injection, USP, the resulting pH is 
approximately
. Each single-use vial contains 100 mg infliximab, 
 mg sucrose,
mg polysorbate 80, 
 mg monobasic sodium phosphate, monohydrate, and 
 mg 
dibasic sodium phosphate, dihydrate.  No preservatives are present.
Infliximab will be provided from commercial supplies.
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Investigators will prescribe MTX according to standard local practice. Additional details 
are provided in Section 8.5.1.
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A manual containing detailed information regarding the labeling, packaging, storage, 
preparation, and administration of each investigational product (eg, test and comparator 
product) and brief information about other protocol-required therapies will be provided 
separately in the Pharmacy Guide.
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The investigational product containers are different for ABP 710 and infliximab, 
therefore, investigational product (ABP 710 or infliximab) will be prepared by an 
unblinded pharmacist or designee for administration to the subject. The subjects, the 
sponsor (Amgen Inc.), designated PRA study personnel, and other study center staff will 
be blinded to the investigational product allocation for each subject. Randomization data
will be kept strictly confidential, filed securely by the sponsor (or designee), and 
accessible only to authorized persons per sponsor’s (or designee’s) standard operating 
procedures until the time of unblinding. Select PRA staff (eg, unblinded clinical research 
associates) who will not be involved in the monitoring or the daily operations of the study 
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will be unblinded to subject investigational product allocation to perform investigational 
product accountability.
For details on the emergency procedure for unblinding of individual subjects see 
Section 8.5.10, below.
At randomization, randomization numbers will be assigned to each subject by the 
interactive voice and web response system (IXRS).
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Investigational product must not be used for purposes other than those defined in this 
protocol.
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The investigational product should be stored at °C to °C in a secure limited access 
location. ABP 710 and infliximab should be stored protected from light and according to 
the storage and expiration information (where required) provided on the label that is 
affixed to the package containing the investigational product. After reconstitution, the 
investigational product should be stored in a refrigerator ( °C to °C).

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All supplies of investigational product will be accounted for in accordance with GCP. 
7KHUHZLOOEHDPDVWHUVWXG\GUXJDFFRXQWDELOLW\UHFRUGFRPSOHWHGand the 
pharmacist, or designee, should maintain accurate records of the disposition of all 
investigational product supplies received during the study. These records should include 
the amounts and dates that investigational products were received and 
destroyed/returned to the sponsor or its designee. If errors or damages in the 
investigational product shipments occur, the investigator should contact the sponsor or
its designee immediately. Copies of the investigational product accountability records 
will be provided by each investigator for inclusion in the Trial Master File after database 
lock. The unblinded study monitor will periodically check the supplies of investigational 
product held by the investigator or pharmacist to verify accountability of investigational 
product used.
The investigator RUGHVLJQHH will administer the investigational product only to the 
identified subjects of this study, according to the procedures described in this study 
protocol. After the end of the study, all unused investigational product and all medication 
containers should be destroyed at the study center or returned to the sponsor or its 
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Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 36 of 82
Confidential
designee for destruction. In either instance, complete documentation will be returned to 
the sponsor.
8.5.6
Dose Adjustments and Dose Escalation
No dose reductions or escalations are planned for the investigational products used in 
this study, except for weight-based dosing changes.
8.5.7
Prior and Concomitant Therapy
8.5.7.1
Permitted Concomitant Treatments (Medications and 
Therapies)
The following concomitant medications are permitted:

methotrexate as specified in Section 8.5.1

oral corticosteroids at a dose of ≤ 10 mg prednisone, or equivalent, per day 
are permitted provided they are at a stable dose for at least 4 weeks before 
initiation of investigational product. The dose of oral corticosteroids may be 
reduced according to local guidelines during the conduct of the study

nonlive vaccinations are allowed any time throughout the study
If at any time a subject clinically needs additional therapy (other than those specified in 
Section 8.5.7.3), including a significant increase in the MTX dose to treat RA, the 
investigator should contact the Amgen medical monitor (or designee) to determine if the 
subject is eligible to remain on investigational product. If the subject is no longer eligible 
to remain on investigational product, then the subject should undergo the evaluations 
and procedures described in Section 8.4.3.2.
8.5.7.2
Prohibited Concomitant Medications
All of the following are prohibited at any time during the study:

nonbiologic DMARDs (other than MTX; as per exclusion criteria)

any biologic treatment for RA (eg, anakinra, soluble IL-1 type II receptor, 
etanercept, infliximab [except for investigational product], onercept, 
abatacept, tocilzumab, golimumab, certolizumab, rituximab, and 
adalimumab)

chronic minocycline or tetracycline (except use for ≤ 10 days to treat 
infection, or for nonarthritis indications, eg, acne), hydroxychloroquine, 
mycophenolate mofetil, or sulfasalazine

live and attenuated vaccinations are not allowed while subjects are enrolled 
in the study and receiving investigational product

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 37 of 82
Confidential

any experimental (biological or nonbiological) therapy (within or outside a 
clinical study)

intra-articular hyaluronic acid

intra-articular, IM, or IV corticosteroids, including adrenocorticotropic 
hormone

Janus kinase inhibitor (eg, tofacitinib)
8.5.7.3
Rescue Medication
The definition of rescue medication is any medication other than prohibited medication 
that is used to treat RA. The use of rescue medication is allowed in this study under the 
following conditions:

oral corticosteroids: the maximum dose allowed is 10 mg prednisone (or 
equivalent) per day; the dose can be decreased if needed, per the 
investigator’s clinical judgment

acetaminophen, hydrocodone, codeine, tramadol, and/or propoxyphene 
may be used by the subject as rescue analgesics. However, no rescue 
analgesics will be allowed within 12 hours before clinical efficacy 
assessments (ie, at baseline and weeks 2, 6, 14, 22, 30, 34, 38, 46, and 
50)

NSAIDs/cyclooxygenase-2 (COX-2) inhibitors: If the subject enters the 
study taking an NSAID/COX-2 inhibitor, the dose of NSAIDs/COX-2 
inhibitors can be reduced or discontinued during the study if necessary for 
safety reasons or standard of care. In cases of flare, the dose of 
NSAIDs/COX-2 inhibitors can be temporarily increased as needed. 
However, the subject must return to the maintenance dose (the dose at 
baseline) as soon as the flare resolves. In subjects not taking an 
NSAID/COX-2 inhibitor, one may be added temporarily to treat a flare in 
RA. It should be tapered and discontinued with resolution of flare. In all 
cases, these agents will not be allowed within 12 hours before clinical 
efficacy assessments (ie, at baseline and weeks 2, 6, 14, 22, 30, 34, 38, 
46, and 50)

topical anesthetic creams (eg, lidocaine/prilocaine creams and licensed 
NSAID creams) are permitted. However, these agents will not be allowed 
within 12 hours before clinical efficacy assessments (ie, at baseline and
weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50)

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Certain adverse events are commonly associated with MTX treatment. To minimize 
MTX toxicity, subjects may receive a stable dose of oral folate or folinic acid. This can 
either be given as a single dose given weekly or as a divided weekly dose, at the 
investigator's discretion.
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Any other treatment (not explicitly excluded) considered necessary for the subject’s 
welfare may be given at the discretion of the investigator. Administration of concomitant 
medications must be recorded. Generic names for concomitant medication should be 
used, if possible.
All subjects who discontinue the investigational product should be offered alternative 
treatment if applicable. Treatment should be given according to normal clinical practice, 
after an end-of-study visit (see Section 8.4.3.2).
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Records of investigational product used and intervals between visits will be kept during 
the study. Drug accountability will be noted by the unblinded field monitor during study 
center visits and at the completion of the study. The investigational product should be 
dispensed by the investigator or by a qualified individual under the investigator’s 
supervision. An up-to-date treatment inventory/dispensing record must be maintained.
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When subjects enter the screening period for the study, the investigator (or designee) 
will contact the IXRS and receive a unique 11-digit subject identification number before 
any study procedures are performed.  This number will be used to identify the subject
throughout the clinical study and must be used on all study documentation related to that 
subject. 
 
 
 
 
The subject identification number must remain constant throughout the entire clinical 
study; it must not be changed at the time of rescreening, enrollment, randomization, or 
re-randomization. This number will not necessarily be the same as the randomization 
number assigned for the study.
PPD

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 39 of 82
Confidential
Upon completion of screening, the investigator (or designee) will contact the IXRS to 
randomize the subject centrally to receive either ABP 710 or infliximab in a 1:1 manner. 
The randomization will be stratified based on geographic region and prior biologic use 
(yes versus no) for RA (with prior biologic use capped at 30% of the study population). 
At week 22, subjects initially randomized to the infliximab group will be re-randomized in 
a 1:1 ratio (via IXRS) to either continue receiving infliximab every 8 weeks or switch to 
the ABP 710 group. Re-randomization will be managed to ensure that the blind to the 
initial study group is maintained.
8.5.10
Unblinding Procedures
A subject’s treatment assignment should only be unblinded when knowledge of the 
treatment is essential for the further management of the subject on this study.
Unblinding at the study center for any other reason will be considered a protocol 
violation.  The investigator is strongly encouraged to contact the Amgen medical monitor
(or designee) before unblinding any subject’s treatment assignment, but must do so 
within 1 working day after the event.
The identity of investigational product assigned to subject numbers or to individual boxes 
of investigational product will be available for emergency situations through the IXRS. 
Authorized study center staff will be provided with a unique Personal Identification 
Number (PIN) to access the IXRS to obtain unblinding information. This PIN is unique to 
the individual and must not be shared.
8.6
Efficacy and Safety Variables
8.6.1
Efficacy and Safety Measurements Assessed
A schedule of procedures and assessments is presented in Table 8-1.

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Screening
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Baseline
Week
Day 1
2
6
14
22
30
34
38
46
50/EOS
a
Pharmacokinetic samples
j
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Antidrug antibodies
k
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l
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Page 2 of 2
BP = blood pressure (systolic and diastolic); CRP = C-reactive protein; ECG = electrocardiogram; EOS = end-of-study; HAQ-DI = Health Assessment Questionnaire –
Disability Index; HBsAg = hepatitis B surface antigen; HCV = hepatitis C virus; RR = respiratory rate; temp = temperature.
a  For subjects who terminate early, perform the evaluations and procedures for end-of-study.
b Weight will be measured before infusion at each dosing visit.  The dose will be adjusted based on weight changes at each visit, if required.
c  Vital signs will be measured before and after infusion at all dosing visits.
d   Chest radiography within 3 months before screening is acceptable (both anteroposterior and lateral incidences are required).
e   Only serious adverse events are reported during the screening period.
f ABP 710/infliximab will be administered after all other procedures are completed for each visit.  If the subject presents with an infection at the dosing visit(s), the
administration of investigational product may be delayed (up to 5 days).
g   Purified protein derivative (PPD); < 5 mm of induration at 48 to 72 hours after test is placed OR negative Quantiferon test; subjects with positive PPD/Quantiferon test may 
be eligible based on the sponsor’s worksheet and the other criteria listed in inclusion criterion 13.
h   Includes rheumatoid factor and anti-CCP.
i C-reactive protein will be performed by the central laboratory and results will be blinded from the study centers at the baseline visit and onward.  Erythrocyte sedimentation 
rate may be used instead of CRP at screening only.
j     
 

k During the weeks when antidrug antibody samples are drawn, predose samples will be collected, with the exception of week 34 and week 50/end-of-study time points 
which do not have investigational product administration.  Therefore, at these time points, the time of sample collection will be recorded.
l    Pregnancy testing required for women of childbearing potential.  Serum pregnancy test will be done at screening by the central laboratory.  Urine pregnancy test 
performed locally at subsequent time points.
CCI
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Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
Page 42 of 82
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8.6.1.1
Efficacy Measurements
8.6.1.1.1
Primary Efficacy Criterion
The primary endpoint is the response difference (RD) of 20% improvement in ACR core set 
measurements (ACR20) at week 22.
ACR20
To achieve ACR20 response, at least 20% improvement compared with baseline is
required for both swollen joint count (SJC) and tender joint count (TJC) (66/68 joint
counts; Section 17.3), as well as for 3 out of the following 5 additionalparameters:

Subject's Global Health Assessment (on a 100-mm visual analogue scale 
[VAS]; Section 17.4)

Investigator's Global Health Assessment (on a 100-mm VAS; Section 17.4)

subject's assessment of pain (on a 100-mm VAS; Section 17.4)

Health Assessment Questionnaire-Disability Index (HAQ-DI) (Section 17.4)

serum CRP
8.6.1.1.2
Secondary Efficacy Criteria
The secondary endpoints are:

response difference of ACR20 at weeks 2, 6, 14, 30, 34, 38, 46, and 50

response difference of at least 50% improvement in ACR core set 
measurements (ACR50), and at least 70% improvement in ACR core set 
measurements (ACR70) at weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50

disease activity score in 28 joints - C-reactive protein (DAS28-CRP) change 
from baseline at weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50
ACR50 and ACR70
ACR50 and ACR70 are defined in a similar fashion to ACR20, but require at least 50% and 
70% improvement respectively, compared with baseline for both swollen and tender joint 
counts, as well as for 3 out of 5 additional parameters (Subject’s GlobalHealth Assessment, 
Investigator’s Global Health Assessment, subject’s assessment of pain, HAQ-DI, and CRP).

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The DAS28-CRP is a composite measure of disease activity in RA. It is a continuous 
measure based on 28 Disease Activity Score (DAS) joints from the ACR, the Subject's 
Global Health Assessment score and CRP, as follows:
DAS28-CRP = 0.56*(TJC28)0.5 + 0.28*(SJC28)0.5 + 0.36*ln(CRP+1) + 0.014*GH + 0.96
where TJC28 is the tender joint count of the 28 joints in the DAS, SJC28 is the swollen 
joint count of the 28 joints in the DAS, CRP is in mg/L, and GH is the Subject's Global 
Health Assessment on a 0 to 100 scale.
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The safety endpoints are:
•
treatment-emergent adverse events, serious adverse events, and adverse 
events of special interest
•
clinically significant changes in laboratory values and vital signs
•
incidence of antidrug antibodies
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CCI

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9
STUDY EVALUATIONS BY VISIT
After signing of the informed consent at the screening visit, there will be 10 additional 
visits.  Treatment visits will occur on day 1 (day of first treatment), and weeks 2, 6, 14, 
22, 30, 38, and 46.  Disease assessments will be performed on day 1, at weeks 2, 6, 14, 
22, 30, 34, 38, 46, and at the follow-up week 50/end-of-study visit.
9.1
Screening
After subjects have provided informed consent, the following assessments/procedures at 
the screening visit must be completed within 28 days of the baseline visit:

subject’s assessment of pain (Section 17.4); subjective assessments will be 
the first assessments performed at the visit

targeted medical history, including history of all prior treatments for RA 
within the past 3 years and any prior biologic therapy for RA

physical examination including evaluation of body systems, height, and 
weight

vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)

standard 12-lead electrocardiogram (ECG)

chest radiography, including anteroposterior and lateral views (prior 
radiography or formal reports signed off by a radiologist within 3 months of 
screening is acceptable)

screening joint assessments (ACR and DAS tender/swollen joint counts; 
Section 17.3)

tuberculosis testing (PPD or Quantiferon test)

clinical laboratory testing, including serology, serum chemistry, hematology, 
ESR and/or CRP, rheumatoid factor, and anti-CCP

collection of urine sample for urinalysis

serum pregnancy test for women of childbearing potential
At the screening assessment, all concomitant medications from 3 months before the 
planned start of investigational product, all prior treatments for RA within the past 
3 years, and any prior biologic therapy for RA will be recorded.  Any adverse events 
occurring during the screening period will be recorded as medical history. Serious 
adverse events will be reported as outlined in Section 11.2.2.

Product: ABP 710
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Subjects will continue on their stable prestudy MTX regimen and folate or folinic acid 
regimen during the screening period.
9.1.1
Screen Failures
If a subject has not met all eligibility criteria at the end of the screening period, the 
subject will be registered as a screen fail. Laboratory assessments used to determine 
subject eligibility may be repeated during the screening period before the subject is 
considered a screen failure. Screen failed subjects may be rescreened up to 2 times at 
the investigator’s discretion (ie, a total of 3 screens including initial screening). If 
screening procedures cannot be completed within 28 days before day 1, the 
subject will be considered a screen failure but may be eligible for rescreening.  
These subjects can be rescreened under the same ICF if rescreening occurs 
within 30 days of initial consent date.  The subject will retain the same subject 
identification number provided at the initial screening. Subjects must be re-consented if 
more than 30 days have elapsed between date of initial informed consent and date of 
rescreen/randomization.
9.2
Baseline (Day 1, first day of treatment, Week 0)
Day 1 will be defined as the first day of treatment. After subjects are confirmed to meet 
the entry criteria (Section 8.4), the investigator (or designee) will contact the IXRS to 
randomize the subject centrally to receive either ABP 710 or infliximab. The following 
assessments/procedures will be performed before treatment:

subjective assessments (Subject's Global Health Assessment, 
Investigator’s Global Health Assessment, subject's assessment of pain, and 
HAQ-DI, Section 17.4); subjective assessments will be the first 
assessments performed at the visit

weight (dose will be calculated based on measured weight)

vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)

baseline joint assessments (ACR and DAS tender/swollen joint counts; 
Section 17.3); the baseline joint assessment must be performed before 
randomization

clinical laboratory testing, including serum chemistry, hematology, and CRP

urine pregnancy test for women of childbearing potential

Product: ABP 710
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Date:  17 March 2017
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
collection of pretreatment pharmacokinetic sample and pretreatment 
sample for antidrug antibodies
Any changes in concomitant medications since the screening visit will be recorded. Any 
pretreatment adverse events will be recorded using the medical history eCRF; any 
pretreatment serious adverse events will be recorded using the adverse event eCRF. 
Serious adverse events will be reported as outlined in Section 11.2.2. Premedications 
must be given.  Premedications should be selected according to local practice and/or
the approved product label. These medications should generally include 
acetaminophen, an antihistamine, and methylprednisone 100 mg IV or equivalent 
30 minutes before each infusion but should be selected according to the individual 
subject’s needs.
After completion of pretreatment procedures (including predose pharmacokinetic sample 
and antidrug antibody collection), ABP 710 or infliximab will be administered as an IV 
infusion in a double-blinded fashion; investigational product will be assigned based on 
box numbers provided by the IXRS. Starting at the time of first treatment, all adverse 
events, including increases in severity or frequency of pre-existing conditions, will be 
recorded in the adverse event eCRF.
At the end of infusion, the following assessments will be performed:

vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)

collection of postdose pharmacokinetic sample (within 10 minutes after the 
end of infusion)
Subjects will continue on their stable MTX regimen.
9.3
Week 2 (2 days), Week 6 (3 days), and Week 14 (3 days)
The subject will return to the study center at week 2 (± 2 days), week 6 (± 3 days), and 
week 14 (± 3 days). The following assessments/procedures will be performed before 
treatment:

subjective assessments (Subject's Global Health Assessment, 
Investigator’s Global Health Assessment, subject's assessment of pain, and 
HAQ-DI, Section 17.4); subjective assessments will be the first 
assessments performed at the visit

weight (dose will be adjusted based on weight changes, if required)

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•
vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)
•
joint assessments (ACR and DAS tender/swollen joint counts; Section 17.3)
•
clinical laboratory testing, including serum chemistry, hematology, and CRP
•
 and sample for antidrug 
antibodies
•
urine pregnancy test for women of childbearing potential (required only at 
week 6)
Any changes in concomitant medications since the last assessment will be recorded. All 
adverse events, including increases in severity or frequency of pre-existing conditions, 
will be recorded in the eCRF. Serious adverse events will be reported as outlined in
Section 11.2.2.
After completion of pretreatment procedures, ABP 710 or infliximab will be administered 
as an IV infusion in a double-blinded fashion.
At the end of infusion, the following assessments will be performed:
•
vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)
•
collection of postdose pharmacokinetic sample (within 10 minutes after the 
end of infusion)
Subjects will continue on their stable MTX regimen.
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The subject will return to the study center at week 22 (± 3 days). The following 
assessments will be performed before re-randomization and treatment:
•
subjective assessments (Subject's Global Health Assessment, 
Investigator’s Global Health Assessment, subject's assessment of pain, and 
HAQ-DI); subjective assessments will be the first assessments performed 
at the visit
•
joint assessments (ACR and DAS tender/swollen joint counts; Section 17.3)
•
physical examination, including evaluation of body systems
•
weight (dose will be adjusted based on weight changes, if required)
•
vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)
CCI

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•
clinical laboratory testing, including serum chemistry, hematology, and CRP
•
 and sample for antidrug 
antibodies
•
collection of urine sample for urinalysis
•
urine pregnancy test for women of childbearing potential
In addition, any changes in concomitant medications since the last assessment will be 
recorded. All adverse events, including increases in severity or frequency of pre-existing 
conditions, will be recorded in the eCRF. Serious adverse events will be reported as 
outlined in Section 11.2.2.
After completion of pretreatment procedures, the investigator (or designee) will contact 
the IXRS, and subjects initially randomized to the infliximab group will be re-randomized 
(in a 1:1 ratio) to either continue to receive infliximab (treatment group B1) or switch to 
ABP 710 (treatment group B2). Subjects initially randomized to ABP 710 (treatment 
group A) will continue on the same treatment. Re-randomization will be managed to 
ensure that the blind to the initial study group is maintained.
Investigational product will be administered by IV infusion in a double-blinded fashion. 
At the end of infusion, the following assessments will be performed:
•
vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)
•
collection of postdose pharmacokinetic sample (within 10 minutes after the 
end of infusion)
Subjects will continue on their stable MTX regimen.

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The subject will return to the study center at week 30 ( 5 days). The following 
assessments/procedures will be performed before treatment:
•
subjective assessments (Subject's Global Health Assessment, 
Investigator’s Global Health Assessment, subject's assessment of pain, and 
HAQ-DI, Section 17.4); subjective assessments will be the first 
assessments performed at the visit
•
weight (dose will be adjusted based on weight changes, if required)
•
vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)
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Product: ABP 710
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Date:  17 March 2017
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
joint assessments (ACR and DAS tender/swollen joint counts; Section 17.3)

clinical laboratory testing for hematology and CRP

collection of predose pharmacokinetic sample and sample for antidrug 
antibodies
Any changes in concomitant medications since the last assessment will be recorded. All 
adverse events, including increases in severity or frequency of pre-existing conditions, 
will be recorded in the eCRF. Serious adverse events will be reported as outlined in 
Section 11.2.2.
After completion of pretreatment procedures, ABP 710 or infliximab will be
administered as an IV infusion in a double-blinded fashion.
At the end of infusion, the following assessments will beperformed:

vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)
Subjects will continue on their stable MTX regimen.
9.6
Week 34 (5 days)
The subject will return to the study center at week 34 (± 5 days), but will not be
administered investigational product at this visit.  The following
assessments/procedures will be performed:

subjective assessments (Subject's Global Health Assessment, 
Investigator’s Global Health Assessment, subject's assessment of pain, and 
HAQ-DI, Section 17.4); subjective assessments will be the first 
assessments performed at the visit

joint assessments (ACR and DAS tender/swollen joint counts; Section 17.3)

clinical laboratory testing, including serum chemistry, hematology, and CRP

collection of pharmacokinetic sample and sample for antidrug antibodies

collection of urine sample for urinalysis

urine pregnancy test for women of childbearing potential
Any changes in concomitant medications since the last assessment will be recorded.  
All adverse events, including increases in severity or frequency of pre-existing
conditions, will be recorded in the eCRF.  Serious adverse events will be reported as 
outlinedin Section 11.2.2.

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Subjects will continue on their stable MTX regimen.
9.7
Weeks 38 and 46 (5 days)
The subject will return to the study center at weeks 38 and 46 (± 5 days).  The
following assessments/procedures will be performed beforetreatment:

subjective assessments (Subject's Global Health Assessment, 
Investigator’s Global Health Assessment, subject's assessment of pain, and 
HAQ-DI, Section 17.4); subjective assessments will be the first 
assessments performed at the visit

weight (dose will be adjusted based on weight changes, if required)

vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)

joint assessments (ACR and DAS tender/swollen joint counts; Section 17.3)

clinical laboratory testing for hematology and CRP

collection of predose pharmacokinetic sample and sample for antidrug 
antibodies (required only at week 38)

urine pregnancy test for women of childbearing potential (required only at 
week 46)
Any changes in concomitant medications since the last assessment will be recorded.  
All adverse events, including increases in severity or frequency of pre-existing
conditions, will be recorded in the eCRF.  Serious adverse events will be reported as 
outlinedin Section 11.2.2.
After completion of pretreatment procedures, ABP 710 or infliximab will be
administered as an IV infusion in a double-blinded fashion.  Week 46 is the final dose
of investigational product in this study.
At the end of infusion, the following assessments will beperformed:

vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)
Subjects will continue on their stable MTX regimen.

Product: ABP 710
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9.8
Week 50/End-of-Study (5 days)
The subject will return to the study center at week 50/end-of-study (5 days).  
Subjects who terminate early will also attend this visit.  The following 
assessments/procedures will be performed:

subjective assessments (Subject's Global Health Assessment, 
Investigator’s Global Health Assessment, subject's assessment of pain, and 
HAQ-DI, Section 17.4); subjective assessments will be the first 
assessments performed at the visit

joint assessments (ACR and DAS tender/swollen joint counts; Section 17.3)

clinical laboratory testing, including serum chemistry, hematology, 
urinalysis, and CRP

collection of pharmacokinetic blood sample and sample for antidrug 
antibodies

physical examination, including evaluation of body systems

vital signs (systolic and diastolic blood pressure, pulse, respiration rate, and 
temperature)

urine pregnancy test (for women of childbearing potential)
Any changes in concomitant medications since the last assessment will be recorded.  
All adverse events, including increases in severity or frequency of pre-existing
conditions, will be recorded in the eCRF through 28 days after the last treatment with 
ABP 710/infliximab.  Serious adverse events will be reported as outlined in
Section 11.2.2.  On completion of the week 50 visit assessments, subjects will be
considered study completers.  Any serious adverse events ongoing at week 50 or at 
the end ofthe study will be followed until they resolve or are considered chronic or
stable.

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Date:  17 March 2017
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10 METHODS OF ASSESSMENT
10.1
Efficacy Assessments
At each time point for RA assessments, the Subject's Global Health Assessment, 
Investigator’s Global Health Assessment, subject's assessment of pain, and HAQ-DI
(Section 17.4) will be completed. These assessments should be the first assessments 
performed at the visits for which they are scheduled.
At these same time points, joints will be assessed and classified as swollen/notswollen
and tender/not tender by pressure and joint manipulation on physical examination.  
Joint prosthesis, arthrodesis, or fused joints will not be assessed for swelling or
tenderness.
The joints to be assessed for swelling and tenderness are given in Section 17.3, 
including the 66/68 joint set for ACR and the 28 joint count for DAS. All joint 
assessments will be performed by an experienced joint evaluator. The evaluator cannot 
be the treating physician and cannot interact with the subject on the study beyond the 
assessment of joints. The evaluator should not discuss the subject’s clinical status nor 
should the evaluator have access to subject medical records or eCRFs, including prior 
joint assessments.  The same evaluator should perform joint assessments across all 
time points for a subject where possible.
For the screening and baseline joint counts, the distal interphalanges shouldbe
evaluated, but should not be included in the total joint count to determine eligibility.
The Investigator's Global Health Assessment will also be completed at the times
indicated in Table 8-1.  The independent joint assessor may not complete the
Investigator’s Global Disease Assessment.  The physician completing the
Investigator’s Global Disease Assessment will have access to the joint assessments.  
The subjectand physician must complete the global assessments independently from 
eachother.
10.2
Safety Assessments
10.2.1
Pregnancy Test
Pregnancy will be determined by evaluation of beta-human chorionic gonadotrophinin
serum at screening by the central laboratory and in urine at subsequent timepoints
locally for all women of childbearing potential.  Subjects who are pregnant willbe
excluded from the study.

Product: ABP 710
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The investigator will inform the sponsor immediately of any case of pregnancy and
collect information on any female subject who becomes pregnant while participating in 
this study and in case of pregnancy among female partners of male subjects.  The
subject will also be followed to determine the outcome of thepregnancy.
10.2.2
Physical Examination
Physical examinations will be performed by a physician and will include examinationof
the following: general appearance, head, ears, eyes, nose, throat, neck, skin,
cardiovascular system, respiratory system, abdominal system, and nervous system.  
For each body system, an assessment of normal or abnormal will be recorded.  
Clinically relevant changes from baseline will be reported as adverseevents.
Body weight (kg) will be measured without shoes or jacket at screening, baseline,and
before infusion at each dosing visit, and dose of investigational product will beadjusted
for weight changes, if required.  Height will be determined atscreening.
10.2.3
Vital Signs
Systolic blood pressure and diastolic blood pressure will be measured on the same
arm (preferentially on the left arm) after the subject has been in a supine/sitting position
for 5 minutes.  Pulse will be recorded simultaneously with blood pressure
measurements.  Respiration rate and temperature will also be recorded.  Vital signs 
will be measuredat screening, before and after infusion at each dosing visit, and at the 
end-of-studyvisit.
During the study, measurement of vital signs may be repeated at the discretion ofthe
investigator for safety reasons.  Clinically relevant abnormal findings will be reported
as adverse events.
10.2.4
Electrocardiogram
Computerized 12-lead ECG recordings will be obtained after the subject has been
supine for 5 minutes.  Each lead will be recorded for at least 3 to 5 beats at a speedof
25 mm/sec paper speed and 10 mm/mV amplitude.  At a minimum, heart rate,
P-wave, PR-interval, QRS-wave, QT-interval, and corrected QT-intervals (msec) will 
berecorded from the 12-lead ECG.  A copy of the ECGs will be retained at the study 
center.  Forthe purposes of screening, the investigator or a designee will evaluate 
whether the ECGis normal or abnormal and whether it is clinically acceptable for
inclusion, if abnormal.

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10.2.5
Tuberculosis Testing
A tuberculosis test will be performed at screening by PPD or Quantiferon test.  PPD
tests will be performed locally, and Quantiferon tests will be performed by the central
or local laboratory.  Subjects with positive PPD/Quantiferon test may be eligible 
basedon the sponsor’s tuberculosis risk assessment worksheet and the other criteria 
listed inthe Inclusion Criteria, Section 8.4.1.
10.2.6
Chest Radiography
Chest radiography will be performed at screening as indicated in Table 8-1 and will
include anterior/posterior or posterior/anterior and lateral views.  Chest X-ray
performed at the study center can be read by the investigator.  A formal report, signed 
off bythe investigator, will be filed in the subject’s medical records.  If the X-ray is 
performedoff site, then formal reports signed off by a radiologist should be acceptable.  
Historical films obtained or formal reports signed off by a radiologist within the 3 
months priorto receiving investigational product are acceptable for screening aswell.
10.3
Clinical Laboratory Testing
Venous blood samples will be taken for clinical laboratory tests at the time points
indicated in Table 8-1.  The following parameters will bedetermined:
Serology:  HBsAg, hepatitis B core antibody, and HCVantibody.
Hematology:  Hemoglobin, hematocrit or packed cell volume, red blood cellcount, 
mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, white
blood cell count, differential white cell count, plateletcount.
Clinical chemistry: Sodium, potassium, urea, creatinine, total protein, albumin,total
bilirubin, AST, ALT, alkaline phosphatase, gamma glutamyl transferase, andnonfasting
glucose.  Rheumatoid factor and anti-CCP will be assessed at screening.  C-reactive
protein will be assessed at the time points indicated in Table 8-1.  C-reactiveprotein
results from the baseline visit and onwards will be blinded and not included in the
central laboratory reports to the study center.  Subjects with any abnormal liver 
functiontests should be followed for potential hepatotoxicity.  The investigational 
product shouldbe stopped in cases of jaundice and/or marked liver enzyme elevations.  
Please seeFDA guidance on drug-induced liver injury (US FDA 2009) or applicable 
local country guidance for additional guidance.

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8ULQDO\VLVIUHVKXULQHpH, protein, glucose, bilirubin, blood, urine pregnancy test
for women of childbearing potential.
,PPXQRORJ\Blood samples for antidrug antibody (binding and neutralizing)
assessments will be collected at the time points indicated in Table 8-1.  Samples
testing positive for binding antibodies will also be tested for neutralizing antibodies and
may be further characterized for quantity/titer, isotype, affinity, and presence of
immune complexes.  Additional blood samples may be obtained to rule out antidrug
antibodies during the study.
The above clinical laboratory tests will be sent to and assessed at a centrallaboratory,
except urine pregnancy, which will be assessed locally, and immunology, which will be
sent to central laboratory and analyzed by Amgen or a designee.  Further details of
the procedures to be followed for sample collection, storage, and shipment will be
documented in a Laboratory Manual.
Additional and repeat laboratory safety testing may be performed at the discretion of
the investigator.  Any clinically relevant changes from baseline will be reported as
adverse events.
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During treatment, serum samples will be taken according to Table 8-1.  The exact
times of blood sampling will be recorded.
Details of the procedures to be followed for sample collection, storage, and shipment
will be documented in the Laboratory Manual.
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11 SAFETY DATA COLLECTION, RECORDING, AND REPORTING
11.1
Adverse Events
11.1.1
Definition of Adverse Events
An adverse event is defined as any untoward medical occurrence in a clinical trial
subject.  The event does not necessarily have a causal relationship with
investigational product.  The investigator is responsible for ensuring that any adverse 
eventsobserved by the investigator or reported by the subject are recorded in the 
subject’smedical record as well as in the eCRF.
The definition of adverse events includes worsening of a pre-existing medical
condition.  Worsening indicates that the pre-existing medical condition (eg, diabetes,
migraine headaches, and gout) has increased in severity, frequency, and/or duration,
and/or has an association with a significantly worse outcome.  In the case of 
worsening of a pre-existing condition, the start date of the event is the date when the 
first signsof worsening were observed.  A pre-existing condition that has not worsened 
duringthe study or involves an intervention such as elective cosmetic surgery or a
medical procedure while on study is not considered an adverse event.
11.1.2
Reporting Procedures for Adverse Events
The investigator is responsible for ensuring that all adverse events observed by the
investigator or reported by the subject that occur from the day of randomization until
the week 50 visit (or through 28 days after the last dose of investigational product for
subjects who discontinue study early) are reported using the applicable eCRFAdverse
Event Summary page.  Adverse events observed by the investigator or reported bythe
subject, that occur after signing of informed consent but before randomization wouldbe
recorded.
The investigator must assign the following adverse eventattributes:

adverse event diagnosis or syndrome(s), if known (if not known, signs or
symptoms)

dates of onset and resolution

severity

assessment of relatedness to investigational product

action taken

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Adverse events must be graded for severity according to the National Cancer Institute 
(US) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 
(http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm).
The investigator must assess whether the adverse event is possibly related to the 
investigational product. This relationship is indicated by a “yes” or “no” response to the 
question: “Is there a reasonable possibility that the event may have been caused by the 
investigational product?”
The investigator is responsible for reviewing laboratory test results and determining 
whether an abnormal value in an individual study subject represents a clinically 
significant change from the subject’s baseline values. In general, abnormal laboratory 
findings without clinical significance (based on the investigator's judgment) are not to be 
recorded as adverse events. However, laboratory value changes that require treatment 
or adjustment in current therapy are considered adverse events. Where applicable, 
clinical sequelae (not the laboratory abnormality) are to be recorded as the adverse 
event.
The investigator’s clinical judgment is used to determine whether a subject is tobe
removed from treatment due to an adverse event.  A subject, or subject’s legal
guardian, can also voluntarily withdraw from treatment due to an adverse event.  If the
subject withdraws consent, the subject is encouraged to undergo, at a minimum, an
end-of- study assessment.
11.2
Serious Adverse Events
11.2.1
Definition of Serious Adverse Events
A serious adverse event is defined as an adverse event that meets at least 1 ofthe
following serious criteria:

fatal

life-threatening (places the subject at immediate risk of death)

requires inpatient hospitalization or prolongation of existing hospitalization

results in persistent or significant disability/incapacity

congenital anomaly/birth defect

other medically important serious event

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An adverse event would meet the criterion of “requires hospitalization”, if the event 
necessitated an admission to a health care facility (eg, overnight stay).
If an investigator considers an event to be clinically important, but it does not meet any 
of the serious criteria, the event could be classified as a serious adverse event under
the criterion of “other medically important serious event.” Examples of such events
could include allergic bronchospasm, convulsions, blood dyscrasias, drug-induced liver
injury, or events that necessitate an emergency room visit, outpatient surgery, or
urgent intervention.
11.2.2
Reporting Procedures for Serious Adverse Events
The investigator is responsible for ensuring that all serious adverse events observed by 
the investigator or reported by the subject that occur after signing of the ICF through 
28 days after the last dose of investigational product are recorded in the subject’s 
medical record and are submitted to Amgen.
The serious adverse event must be submitted to Amgen, or its designee, within 24 hours 
following the investigator’s knowledge of the event via the applicable eCRF or via paper 
serious adverse event report form if it occurs prior to randomization, ie, during screening.
If the electronic data capture (EDC) system is not functional, the serious adverse event 
can be reported by faxing a completed paper Serious Adverse Event Fax Cover Sheet 
and serious adverse event report form or by direct telephone communication with PRA 
Safety Risk Management at the numbers provided below. The event must be updated 
electronically in the EDC system by the clinical study center once the EDC function 
resumes.
Fax information to Safety Risk Management/PRA, for the attention of:
PRA Drug Safety Center
For Europe, Asia, and Pacific Region Clinical StudyCenters:
FAX:  +44 1792 525 720
Phone: +49.621.8782.154
CHOSafety@praintl.com
For North America, Latin America, and South America Clinical Study Centers:
FAX: 1.888.772.6919 (North America); 1.434.951.3482 (Latin and South America)
Phone: 1.800.772.2215 (North America); 1.434.951.3489 (Latin and South America)
CHOSafety@praintl.com

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New information relating to a previously reported serious adverse event must be 
submitted to Amgen, or its designee, within 24 hours following knowledge of the new
information.  The investigator may be asked to provide additional follow-up information,
which may include a discharge summary or extracts from the medical record.  Information
provided about the serious adverse event must be consistent with that recorded on the
applicable eCRF (eg, Adverse Event Summary eCRF).
Elective hospitalizations are not considered serious adverse events.  If a subject is
permanently withdrawn from protocol-required therapies because of a serious adverse
event, this information must be submitted to Amgen, or its designee. 
To comply with worldwide reporting regulations for serious adverse events, the treatment
assignment of subjects who develop serious, unexpected, and related adverse events
may be unblinded by Amgen, or its designee, before submission to regulatory
authorities. Investigators will receive notification of related serious adverse event reports
sent to regulatory authorities in accordance with local requirements.
Determination of expectedness for Amgen products will be based on the IB for the
investigational product and the regional prescribing information for products being
studied for an approved use.  Expectedness assessments are to be made for all
investigational products (Amgen and non-Amgen) using the appropriate reference safety
information per local regulatory reporting requirements.  Suspected unexpected serious
adverse reactions (SUSARs) reported for subjects receiving a non-Amgen 
investigational product are to be expedited according to local requirements.
Amgen, or its designee, reports serious adverse events and/or SUSARs as required to
regulatory authorities, investigators/institutions, and IRBs/IECs in compliance with all
reporting requirements according to local regulations and GCPs.
The investigator is to notify the appropriate IRB/IEC of serious adverse events occurring
at the study center and other adverse event reports received from Amgen, in accordance
with local procedures and statutes.
After the protocol-required reporting period defined above, the investigator does not
need to actively monitor subjects for serious adverse events.  However, if the
investigator becomes aware of a serious adverse event after this protocol-required
reporting period, the investigator will report the event to Amgen within 24 hours following
the investigator’s knowledge of the event.  Serious adverse events reported outside of

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the protocol-required reporting period will be captured within the safety database as
clinical trial cases for the purposes of expedited reporting.
11.3
Adverse Events of Special Interest
Adverse events of special interest for ABP 710/infliximab are defined in the IB and 
analyzed from the clinical database using search strategies.  There are noexpedited 
reporting requirements for adverse events of special interest (other than those that
meet other reporting requirements).
11.4
Pregnancy Reporting
Pregnancy in itself is not regarded as an adverse event unless there is a suspicion
that an investigational product may have interfered with the effectiveness of a
contraceptive medication.  However, the outcome of all pregnancies (spontaneous
miscarriage, elective termination, normal birth, or congenital abnormality) must be 
followed upand documented even if the subject was discontinued from thestudy.
All reports of congenital abnormalities/birth defects are serious adverse events.  
Spontaneous miscarriages should also be reported and handled as seriousadverse
events.  Elective abortions without complications should not be handled asadverse
events.  All outcomes of pregnancy must be reported to Amgen, or itsdesignee.
Pregnancy surveillance will include a pregnancy questionnaire that also addresses
lactation surveillance.  Any pregnancy that is ongoing or reported after completion of
the study will be followed up by the sponsor.
Pregnancies in female partners of male subjects will also be reported and followed
for outcome.

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12 DATA MANAGEMENT AND STATISTICAL ANALYSIS
The data management and statistical analysis of this study will be performed by an 
external clinical research organization (CRO), PRA.
12.1
Data Management
Previous and concomitant medications will be coded using the latest availableWorld
Health Organization-Drug Dictionary (WHO-DD).  Coexistent diseases andadverse
events will be coded using Medical Dictionary for Regulatory Activities(MedDRA).
When the database has been declared to be complete and accurate, it will belocked.
12.2
Sample Size Estimation
Approximately 550 subjects will be randomized in a 1:1 ratio to receive either ABP 710 
or infliximab. Subjects will be stratified based on geographic region and prior biologic 
use for RA (with prior biologic use capped at 30% of the study population). The sample 
size is chosen to achieve > 90% power to demonstrate equivalence at a 0.05 
significance level on the primary efficacy endpoint, RD of ACR20 at week 22 between 
ABP 710 and infliximab, with an equivalence margin of (-15%, 15%), assuming an 
expected ACR20 rate for both ABP 710 and infliximab of 52% at week 22. The sample 
size will also achieve approximately 85% power to demonstrate equivalence on the RD 
of ACR20 between ABP 710 and infliximab with an equivalence margin of (-12%, 15%) 
at a significance level of 0.05 at week 22.
12.3
Statistical Analysis Plan
A statistical analysis plan (SAP) will be written and finalized prior to any lock of the
study database.  The SAP will provide a detailed description of the statistical methods
and expand on the details provided in the protocol.  Additional analyses may beadded.
Table, listing, and figure shells will also be included.
12.4
Randomization
Randomization will be performed by an IXRS. The randomization schedule will be 
prepared by a statistician not involved in the conduct of the study. Upon completion of 
screening, approximately 550 eligible subjects will be randomized in a 1:1 ratio to 
receive either ABP 710 3 mg/kg infusion on day 1, at weeks 2 and 6, and every 8 weeks 
thereafter (treatment group A), or infliximab 3 mg/kg infusion on day 1, at weeks 2 and 6, 
and every 8 weeks thereafter (treatment group B), until week 22. Randomization will be

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stratified based on geographic region and prior biologic use for RA (with prior biologic
use capped at 30% of the study population).
At week 22, subjects initially randomized to the infliximab group (treatment group B) will
be re-randomized in a 1:1 ratio (via IXRS) to either continue receiving infliximabevery
8 weeks (treatment group B1) or switch to the ABP 710 group (treatment group B2).  
Subjects initially randomized to ABP 710 (treatment group A) will continue on thesame
treatment.  Re-randomization will be managed to ensure that the blind to the initial
study group is maintained.  Subjects unable to complete the week 22 visit within 
the allowed visit window will not be re-randomized and will be discontinued from 
the study.
12.5
Analysis Sets
The primary analysis for the efficacy endpoints will be performed using theintention-
to- treat analysis set.  The per-protocol analysis set will be used for sensitivity 
analysesof the efficacy endpoints.  The analysis of safety endpoints will be based on 
thesafety analysis set.  Information about the analysis of pharmacokinetic
concentration summaries will be provided in the SAP.
12.5.1
Intention-to-treat Analysis Set
The intention-to-treat analysis set includes all subjects randomized in the
study.  Analyses will be based on randomized treatment (regardless of actual
treatment received).
12.5.2
Per-protocol Analysis Set
The per-protocol analysis set includes all subjects randomized in the study who have 
completed the specified treatment period and did not experience a protocol deviation 
that affected their evaluation for the primary objective of the study. Analyses will be 
based on actual treatment received. Per-protocol analysis sets will be determined 
separately for the primary analysis conducted at week 34, and for the additional analysis 
conducted at the end of the study. The protocol deviations that affect evaluation of the 
primary objective will be determined based on a blinded data review prior to database 
lock.
12.5.3
Safety Analysis Set
The safety analysis set includes all randomized subjects who received any amount of 
investigational product.  Analyses will be based on actual treatmentreceived.

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12.6
Statistical Methods
The primary analysis will be conducted at week 34, when all subjects have either 
completed the week 34 visit or been terminated before the week 34 visit. The end of the 
study will be at week 50, and a final analysis will be conducted when all subjects have 
completed the week 50/end-of-study assessments or been terminated early from the 
study.
For binary endpoints (eg, ACR 20/50/70), the difference in percentages and their CIs will 
be estimated using Mantel-Haenszel estimate of common RDs and stratified Newcombe 
confidence limits for the common RDs to adjust for the stratification factors. For 
continuous endpoints (eg, DAS28-CRP), the CI of the mean difference will be estimated 
using analysis of covariance model with relevant baseline values and stratification 
factors as covariates.
All categorical variables will be summarized using the number and percentage of 
subjects falling into each category and all continuous variables will be summarized using 
mean, standard error or standard deviation, median, minimum, maximum, and number
of subjects with observations. Safety endpoints will be summarized descriptively. 
Subgroup analyses (by age, race, sex, and stratification factors) will be presented if 
deemed necessary.
12.6.1
Missing Data
Imputation rules will be presented in the SAP, which will be finalized before unblinding
of the study.
12.6.2
Demographic and Baseline Data
The following demographic data will be summarized: age (in years, at time of signing
informed consent), race, sex, ethnicity, height, and weight.  Disease history and
baseline disease characteristics will also be summarized.
12.6.3
Subject Disposition
The following information will be summarized for subject disposition and accountability:

number of subjects randomized at the initial and second randomizations will 
be tabulated by country, center, and stratification factor

subject disposition at week 22 and at the end of the study (including 
number of subjects who were randomized, treated with ABP 710/infliximab 
before and after week 22, completed treatment, discontinued treatment with 

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reason for discontinuation, completed study, and discontinued study with 
reasonfor discontinuation)

summaries of analysis populations with reason for exclusion at week 22 
andat the end of the study

important protocol deviations

randomization list of subjects and their actual versus randomizedtreatment
group
12.6.4
Efficacy
All efficacy analyses will be performed using the intention-to-treat analysis set based
on the subject’s randomized treatment.  As a sensitivity analysis, the equivalence test
on the primary endpoint will also be performed using the per-protocol analysisset.
Clinical equivalence for the primary endpoint, RD of ACR20 at week 22, will be
sequentially evaluated: first by comparing the 2-sided 90% CI of the RD of ACR20
between ABP 710 and infliximab with the equivalence margin of (-15%, 15%).  The
CIs will be estimated from the stratified Newcombe confidence limits for the common
RD to adjust for stratification factors.  If the first equivalence is established, the
primary endpoint, RD of ACR20 at week 22, will be further evaluated by comparing 
thesame 2-sided 90% CI between ABP 710 and infliximab with an equivalence 
margin of(-12%, 15%).  In addition to the 90% CI, the 95% CI for all primary and 
secondary efficacy endpoints will also be provided descriptively.
Inferential analyses will only be performed for the primary endpoint.  Secondary
efficacy endpoints, ACR20 at scheduled visits other than week 22, ACR50/ACR70,and
DAS28-CRP will be analyzed descriptively at various timepoints.
12.6.5
Safety
All safety analyses will be performed using the safety analysis set based on actual
treatment received.  Safety analysis will include analyses of adverse events, clinical
laboratory test results, vital signs, and antidrug antibodies.  In general, summaries will
be provided separately as follows: from day 1 (first investigational product
administration) until week 22, from week 22 through the end of the study, and for the 
entire studyperiod (from day 1 [first investigational product administration] through the 
end of thestudy).
The DMC will review safety data at regular intervals throughout the length of the study.

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12.6.5.1
Investigational Product Administration
For the investigational product (ABP 710 or infliximab), summary statistics will be 
provided for the total number of doses and total duration of exposure throughout the 
treatment exposure period.
12.6.5.2
Adverse Events
Safety analyses will focus on treatment-emergent adverse events. Treatment-emergent 
adverse events are those that begin or increase in severity or frequency at or after the 
time of first treatment up to 28 days following the last dose of study treatment (ie, the 
week 50 visit or, if subject discontinues study early, the end-of-study visit). All treatment-
emergent adverse events will be summarized by treatment group and according to the 
MedDRA system organ class and preferred term. Summaries will be provided for the 
incidence of all treatment-emergent adverse events and specific subgroups. Additional 
summaries will be presented for serious adverse events.
All adverse event data will be listed by subject, and a separate listing will include all 
serious adverse events, including any deaths on study.
Adverse events of special interest will be summarized separately.
12.6.5.3
Immunogenicity
The number and percentage of subjects developing binding antidrug antibodies and
those developing neutralizing antidrug antibodies will be tabulated separately for day1 
until week 22, from week 22 through the end of the study, and for the entire studyby
actual treatment received.
12.6.5.4
Concomitant Medications and Therapies
Concomitant medications will be coded by WHO-DD and will be summarized by
treatment group with number and percentage of subjects receiving each categoryof
medication.
12.6.5.5
Clinical Laboratory Tests
Clinical laboratory test results and change from baseline will be summarized by
time point.  In addition, shift tables, from baseline to the worst on-study laboratory
toxicity based on CTCAE version 4.03 grading, will be presented.

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Vital sign data (observed and change from baseline) will be summarizedusing
descriptive statistics by time point andtreatment.
Abnormal findings from physical examinations will be listed by subject and assessed
for clinical significance, and will be included in the adverse event listings and
summaries.
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The primary analysis will be conducted after all subjects have completed the week34
assessments, or have terminated the study before week 34.  Additional informationon
the primary analysis will be available in the SAP.
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A DMC external to Amgen and PRA (Independent DMC) will be formed with members
consisting of individuals chosen for their expertise.  Members of the DMC will include,
at a minimum, physicians external to Amgen and PRA, and appropriate statistical
representation external to Amgen and PRA.  The primary role of this independent
DMC will be to monitor safety data.
The DMC will review unblinded safety data at regular intervals, as outlined in theDMC
charter (approximately twice yearly; the start date will depend on subject accrual
rates).  In addition, the DMC will communicate major safety concerns and
recommendations regarding study modification or termination to Amgen management 
at any timeduring the conduct of the study.
Records of all meetings will be archived.  Selected Amgen, or its designee, staffmay
serve as liaisons to the external DMC, but will not be voting members and will notbe
unblinded to the results.  Details regarding the DMC will be provided in the DMC
charter.
CCI

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13 MONITORING PROCEDURES (QUALITY ASSURANCE)
Amgen has ethical, legal, and scientific obligations to conduct this study in accordance 
with established research principles and ICH GCP guidelines. As such, to fulfill these 
obligations and to maintain current of study progress, Amgen monitors, or Amgen’s 
designees, will visit the study centers during study conduct, in addition to maintaining 
telephone and written communication. On-site visits, telephone calls, and regular 
inspection of the eCRFs will be conducted to assess subject enrollment, compliance with 
protocol procedures, completeness and accuracy of data entered on the eCRFs, 
verification of eCRF data against original source documents, and occurrence of adverse 
events.  The investigator must provide the monitor with full access to all source and 
study documents.
13.1
Routine Monitoring
Amgen, or its designee, assigned monitors will conduct regular study center visits to the 
investigational facilities for the purpose of monitoring various aspects of the study. The 
investigator must agree to Amgen, or its designee, authorized personnel having direct 
access to the clinical (or associated) files and clinical study supplies (dispensing and 
storage areas) for all study subjects considered for study entry for the purpose of 
verifying entries made in the eCRF, and assist with their activities, if requested.
Adequate time and space for monitoring visits should be made available by the 
investigator.
The study center must complete the eCRFs in a timely manner and on an ongoing basis 
to allow regular review by the study monitor.
Whenever a subject name is revealed on a document that is to be collected for the 
sponsor, the name must be blacked out permanently by the study center personnel, 
leaving the initials visible, and must be annotated with the subject number as 
identification.
13.2
Inspections and Auditing Procedures
Amgen, or its designee, may conduct audits at the study centers, including, but not
limited to, drug supply, presence of required documents, the informed consent
process, and comparison of eCRFs with source documents.  All medical records 
(progressnotes) must be available for audit.  The investigator agrees to participate 
with auditsconducted at a convenient time in a reasonable manner.

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Government regulatory authorities may also inspect the investigator during or after the 
study. The investigator or designee should contact Amgen, or its designee, immediately 
if this occurs. He/she must cooperate fully with regulatory authorities or other audits 
conducted at a convenient time in a reasonable manner.
The purpose of an audit is to assess whether ethics, regulatory, and quality 
requirements are fulfilled.

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14 STUDY MANAGEMENT AND MATERIALS
14.1
Electronic Case Report Forms
An eCRF will be used to store and transmit subject information. The file structure and 
format for the eCRF will be provided by the sponsor or their representative and should 
be handled in accordance with the instructions provided.
The eCRF must be reviewed and electronically signed and dated by the investigator.
Access to the eCRF will be strictly password protected and limited to personnel directly 
participating in the study. Data should be entered into the eCRF completely by 
examining personnel or the appropriate study center staff. The eCRF must be 
completed as soon as possible after any subject evaluation or communication. If data 
are to be changed due to erroneous input or another reason, an electronic audit trail will 
track these changes. The eCRFs and computers that store them must be accessible to 
study monitors and other regulatory auditors.
14.2
Data Collection
During each study visit, a physician participating in the study will maintainprogress
notes in the subject’s medical records to document all significant observations.  Ata
minimum, these notes will contain:

the date of the visit and the corresponding day or visit in the study schedule 
(eg, screening, day 1, week 2)

general condition and status remarks by the subject, including any 
significant medical findings. The severity, frequency, duration, and 
resolution of any reported adverse event, and the investigator's assessment 
as to whether or not the reported adverse event is investigational product-
related

changes in concomitant medications or dosages

a general reference to the procedures completed

the signature or initials of all physicians making an entry in the medical 
record (progress notes)
In addition, any contact with the subject via telephone or other means that provides 
significant clinical information will also be documented in the medical record (progress 
notes), as described above.

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Information from the medical records (progress notes) and other source documents will
be promptly transcribed to the appropriate section of theeCRF.
Changes to information in the medical record (progress notes), CRF, and othersource
documents will be initialed and dated on the day the change is made by the
investigator or designee.  If the reason for the change is not apparent, a brief 
explanation forthe change will be written adjacent to the change.
14.3
Source Documents Maintenance
Source documents contain the results of original observations and activities of a clinical
investigation.  Source documents include, but are not limited to, medical records 
(progress notes), computer printouts, screening logs and recorded data from
automated instruments.
All source documents from this study will be maintained by the investigator andmade
available for inspection by authorized persons.  The original signed informed consent
for each subject shall be filed with records kept by the investigator and a copy shall be
given to the subject.
14.4
Record Maintenance
All data derived from the study will remain the property of Amgen.
Records must be retained in accordance with the current ICH Guidelines on GCP. All
essential study documents including records of subjects, source documents, eCRFs, 
and investigational product inventory must be kept on file.
Essential documents should be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region, or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the investigational products. However, 
essential documents may be retained for a longer period if required by the applicable 
regulatory requirements or by agreement with the sponsor.
The investigator shall take responsibility for maintaining adequate and accurate hard 
copy source documents of all observations and data generated during this study. Such 
documentation is subject to inspection by the sponsor, its representatives, and 
regulatory authorities.

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If an investigator moves, withdraws from an investigation, or retires, the responsibility for
maintaining the records may be transferred to another person who will accept
responsibility.  Notice of transfer must be made to and agreed by thesponsor.

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14.5
Confidentiality
All information obtained during the conduct of the study with respect to the subject’s 
state of health will be regarded as confidential. For disclosure of any such information, 
an agreement will be obtained in writing.
The investigator must ensure that each subject’s anonymity is maintained. On eCRFs 
and other documents submitted to the sponsor or the CRO, subjects must not be 
identified by name. Instead, subjects will only be known by the unique subject number 
allocated to them to ensure confidentiality on all study documentation. Subjects will 
retain this unique number throughout the study. The investigator will keep a separate 
log of these codes.
To comply with government regulatory guidelines and to ensure subject safety, it may be 
necessary for the sponsor and its representative, the CRO personnel, the local research 
review board, or the US FDA to review subjects’ medical records as they relate to this 
study. Only the subject’s unique number on the eCRFs will identify him/her, but their full 
names may be made known to a drug regulatory authority or other authorized 
government or health care officials, if necessary, and to personnel designated by the 
sponsor.
Documents that are not for submission to the sponsor or the CRO (eg, consent forms) 
will be maintained by the investigator in strict confidence, except to the extent necessary 
to allow monitoring by the sponsor and the CRO, and auditing by regulatory authorities. 
No documents identifying subjects by name will leave the study center and subject 
identity will remain confidential in all publications related to the study.

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15 ADMINISTRATION PROCEDURES
15.1
Regulatory Approval
Amgen, or their appointed agents, will be responsible for ensuring that appropriate 
regulatory authority approvals are obtained, according to local country requirements.
No subject may enter the study until this approval has been obtained. A copy of the 
approval (where one is provided as requested, according to local country requirements) 
will be provided to the investigator and to the IRB(s)/IEC(s).
15.2
Protocol Amendments
In accordance with ICH Topic E 6 (R1) Guideline for GCP, the investigator should not 
implement any deviation from or changes to the protocol without agreement by the 
sponsor and documented approval from the IRB/IEC of a protocol amendment except 
where necessary to eliminate an immediate hazard(s) to study subjects or when the 
change(s) involves only logistical or administrative aspects of the study (eg, change in 
monitor[s], change of telephone number[s]).
Any change to the protocol must be handled as a protocol amendment. Any potential 
amendment must be approved by the sponsor. A written amendment must be submitted 
to the appropriate regulatory authorities and to the IRB/IEC assuming this responsibility. 
The investigator must await IRB/IEC approval of protocol amendments before 
implementing the changes, except where necessary to eliminate apparent immediate 
hazard to subjects. In these cases, the IRB/IEC must be notified within 5 days of the 
change.
All amendments to the protocol must be approved in writing by both the appropriate 
regulatory authorities and the IRB/IEC, except for administrative amendments, which 
require notification but not written approval. Once approved, the protocol amendment 
will be distributed to all recipients of the original protocol, with instructions to append the 
amendment to the protocol.
If, in the judgment of the local IRB/IEC, the investigator and/or sponsor, the protocol 
amendment alters the study design or procedures and/or increases the potential risk to 
the subject, the currently approved written ICF will require modification. The modified 
ICF must also be reviewed and approved by the sponsor, appropriate regulatory 
authorities, and the IRB/IEC. In such cases, repeat informed consent must be obtained 
from subjects enrolled in the study before participation continues.

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15.3
Protocol Adherence and Deviations
The protocol must be read thoroughly and the instructions must be followed.  
However, exceptions will be made in emergency situations when the protection,
safety, and well-being of the subject requires immediate intervention based on the
judgment of the investigator or (a) responsible, appropriately trained, and credentialed
professional(s) designated by the investigator as a sub-investigator.
In the event of a significant protocol deviation due to an emergency, accident, or
error, the investigator or designee must contact the medical monitor at the earliest
possible time by telephone.  This allows for an early joint decision to be made as to 
whether or not the subject should continue in the study.  The investigator, sponsor, 
andmedical monitor will document this decision.
15.4
Publication Policy
Authorship of any publications resulting from this study will be determined on the basis
of the Uniform Requirement for Manuscripts Submitted to Biomedical Journals
(International Committee of Medical Journal Editors), which states:

Authorship credit is to be based on (1) substantial contributions to 
conception and design, acquisition of data, or analysis and interpretation of 
data; (2) drafting the article or revising it critically for important intellectual 
content; (3) final approval of the version to be published; (4) agreement to 
be accountable for all aspects of the work in ensuring that questions related 
to the accuracy or integrity of any part of the work are appropriately 
investigated and resolved. Authors are to meet conditions 1, 2, 3, and 4.

When a large, multicenter group has conducted the work, the group is to 
identify the individuals who accept direct responsibility for the manuscript. 
These individuals are to fully meet the criteria for authorship defined above.

Acquisition of funding, collection of data, or general supervision of the 
research group, alone, does not justify authorship.

All persons designated as authors are to qualify for authorship, and all 
those who qualify are to be listed.

Each author is to have participated sufficiently in the work to take public 
responsibility for appropriate portions of the content.
All publications (eg, manuscripts, abstracts, oral/slide presentations, book chapters) 
based on this study must be submitted to Amgen for review. The Clinical Trial 

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Agreement between the institution, investigator, and Amgen will detail the procedures 
for, and timing of, Amgen’s review of publications.
15.5
Clinical Study Report
A final clinical study report will be prepared according to the ICH guideline on Structure 
and Contents of Clinical Study Reports. A final clinical study report will be prepared 
regardless of whether the study is completed or prematurely terminated.
15.6
Contractual and Financial Details
The investigator (and/or the hospital administrative representative) and Amgen, or its 
designee, will sign a clinical study agreement prior to the start of the study, outlining 
overall Amgen, or its designee, and investigator responsibilities in relation to the study. 
Financial Disclosure Statements will be completed only as required by local regulations.
15.7
Compensation
Any arrangements for compensation to subjects for injury or illness that arises in the 
study are described in the Compensation for Injury section of the Informed Consent that 
is available as a separate document.
15.8
Discontinuation of the Study
This study may be terminated by Amgen at any time. In terminating the study, Amgen, 
the CRO (PRA), and the investigator will ensure that adequate consideration is given to 
protection of the subjects’ interests. Amgen will not provide ABP 710 or infliximab after 
termination of the trial or upon discontinuation of the study for the subject.
15.9
Study Center File Management
The investigator is responsible for assuring that the Study Center File is maintained. 
The Study Center File will contain, but not be limited to, the information listed below:

investigator’s brochure

current, signed version of the protocol and any previous versions of the 
protocol

protocol amendments (if applicable)

operations manual (if applicable)

current ICF (blank) and any previous versions of the ICF

Product: ABP 710
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
Curricula Vitae of investigator(s) and sub-investigator(s) and photocopy of 
their respective license(s) where required by law; Original US FDA Form 
1572 (for all studies conducted under US Investigational New Drug 
regulations), signed by all principal investigators. The names of any sub-
investigators must appear on this form. Investigators must also complete 
all regulatory documentation as required by the ICH GCP and by local or 
national regulations

documentation of IRB/IEC approval of the protocol, the ICF, any protocol 
amendments, and any ICF revisions

all correspondence between the investigator, IRB/IEC, and the 
sponsor/CRO relating to study conduct

laboratory certification(s)

monitoring log

investigational product invoices

signature list of all staff completing eCRFs

signature list of all staff completing drug accountability summaries

Product: ABP 710
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16 REFERENCE LIST
Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO III, etal.
2010 Rheumatoid arthritis classification criteria: an American College of
Rheumatology/European League Against Rheumatism CollaborativeInitiative.  
Arthritis Rheum. 2010;62(9):2569–2581.
Amgen.  ABP 710 Investigator’s Brochure.  Edition 3:  March2016.
Butler DM, Maini RN, Feldmann M, Brennan FM.  Modulation of proinflammatory
cytokine release in rheumatoid synovial membrane cell cultures.  Comparisonof
monoclonal anti TNF-alpha antibody with the interleukin-1 receptor antagonist. Eur
Cytokine Netw. 1995;6(4):225-230.
Carrasco R, Barton A.  Biomarkers of outcome in rheumatoidarthritis.  
Rheumatology Reports.  2010;2(e3):doi:10.4081/rr.2010.e3.
Chin JE, Winterrowd GE, Krzesicki RF, Sanders ME.  Role of cytokines in
inflammatory synovitis.  The coordinate regulation of intercellular adhesion
molecule 1 and HLA class I and class II antigens in rheumatoid synovial 
fibroblasts.  Arthritis Rheum. 1990;33(12):1776-1786.
Choy EH, Panayi GS.  Cytokine pathways and joint inflammation inrheumatoid
arthritis.  N Engl J Med. 2001;344(12):907-916.
European Medicines Agency (EMA), Committee for Medicinal Products forHuman
Use (CHMP).  Guideline on similar biological medicinalproducts.
EMA/CHMP/437/04-Rev 1 October 2014.  EMA.
European Medicines Agency (EMA), Committee for Medicinal Products for
Human Use (CHMP).  Guideline on similar biological medicinal products
containing biotechnology-derived proteins as active substance: qualityissues.
EMA/CHMP/BWP/247713/2012 Rev 1 May 2014.
European Medicines Agency (EMA), Committee for Medicinal Products for
Human Use (CHMP).  Guideline on similar biological medicinal products
containing biotechnology-derived proteins as active substance: non-clinical and
clinical issues.
EMEA/CHMP/BMWP/42832/2005 Rev 1 December 2014.

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
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European Medicines Agency (EMA), Committee for Medicinal Products for
Human Use (CHMP).  Guideline on similar biological medicinal products
containing monoclonal antibodies: non-clinical and clinicalissues.
EMEA/CHMP/BMWP/403543/2010 Rev 1 June 2012.
Feldmann M, Brennan FM, Miani RN.  Role of cytokines in rheumatoid arthritis.
Annu Rev Immunol. 1996;14:397-440.
Hochberg MC, Rowland WC, Dwosh I, Lindsey S, Pincus T, Wolfe F.  The
American College of Rheumatology 1991 Revised Criteria for the Classification of
Global Functional Status in Rheumatoid Arthritis.  Arthritis Rheum.
1992;35(5):498-502.
Imboden J, Hellmann D, Stone J.  Current Rheumatology Diagnosis & Treatment.
2nd ed.  New York:  McGraw-Hill Companies, Inc; 2007.
McInnes IB, Schett G.  Cytokines in the pathogenesis of rheumatoid arthritis.
Nat Rev Immunol. 2007;7(6):429-442.
Remicade® (prescribing information).  Horsham, PA: Janssen Biotech Inc;
October 2015.
Shingu M, Nagai Y, Isayama T, Naono T, Nobunaga M.  The effects of cytokines
on metalloproteinase inhibitors (TIMP) and collagenase production by human
chondrocytes and TIMP production by synovial cells and endothelial cells.  
ClinExp Immunol. 1993;94(1):145-149.
Tracey D, Klareskog L, Sasso EH, Salfeld JG, Tak PP.  Tumor necrosis factor
antagonist mechanisms of action: a comprehensive review.  Pharmacol Ther.
2008;117(2):244-279.
United States Food and Drug Administration.  Guidance for Industry: Scientific
considerations in demonstrating biosimilarity to a reference product.  April 2015,
US FDA.
United States Food and Drug Administration.  Guidance for Industry: Quality
considerations in demonstrating biosimilarity to a reference protein product.  
April 2015, US FDA.
United States Food and Drug Administration. Guidance for Industry: Drug-
induced liver injury: premarketing clinical evaluation.  July 2009, US FDA.

Product: ABP 710
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17 APPENDICES
17.1
Appendix 1: Elements of Informed Consent
Both the informed consent discussion and the written ICF and any other written 
information to be provided to subjects should include explanations of the following:

That the study involves research.

The purpose of the study.

The study treatment(s) and the probability for random assignment toeach
treatment.

The study procedures to be followed including all invasive procedures.

The subject’s responsibilities.

Those aspects of the study that are experimental.

The reasonably foreseeable risks or inconveniences to the subject and,
when applicable, to an embryo, fetus, or nursing infant.

The reasonably expected benefits.  When there is no intended clinical 
benefitto the subject, the subject should be made aware of this.

The alternative procedure(s) or course(s) of treatment that may be 
availableto the subject, and their important potential benefits and risks.

The compensation and/or treatment available to the subject in the eventof
study-related injury.

The anticipated prorated payment, if any, to the subject for participating in
the study.

The anticipated expenses, if any, to the subject for participating in the
study.

That the subject’s participation in the study is voluntary and that the 
subjectmay refuse to participate or withdraw from the study, at any time, 
without penaltyor loss of benefits to which the subject is otherwise entitled.

That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory
authority(ies) will be granted direct access to the subject’s original medical 
records for verification of clinical study procedures and/or data, without violating
the confidentiality of the subject, to the extent permitted by the applicable laws
and regulations and that, by signing a written ICF, the subject or the subject’s
legally acceptable representative is authorizing such access.

That records identifying the subject will be kept confidential and, to the
extent permitted by the applicable laws and/or regulations, will not be made
publicly available.  If the results of the study are published, the subject’s identity
will remain confidential.

That the subject or the subject’s legally acceptable representative willbe
informed in a timely manner if information becomes available that maybe
relevant to the subject’s willingness to continue participation in thestudy.

The person(s) to contact for further information regarding the study and
the rights of study subjects, and who to contact in the event of study-related
injury.

The foreseeable circumstances and/or reasons under which thesubject’s
participation in the study may be terminated.

The expected duration of the subject’s participation in the study.

The approximate number of subjects involved in the study.

Product: ABP 710
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17.2
Appendix 2: American College of Rheumatology Revised Criteria for 
the Classification of Functional Capacity in RA
American College of Rheumatology revised criteria for classification of functional
status in rheumatoid arthritis a
Class I
Completely able to perform usual activities of daily living(self-
care, vocational, and avocational)
Class II
Able to perform usual self-care and vocational activities, but limited
in avocational activities
Class III
Able to perform usual self-care activities, but limited in vocational
and avocational activities
Class IV
Limited in ability to perform usual self-care, vocational, and
avocational activities
a
Usual self-care activities include dressing, feeding, bathing, grooming, and 
toileting. Avocational (recreational and/or leisure) and vocational (work, school, 
homemaking) activities are patient-desired and age- and sex-specific.
Hochberg MC, Rowland WC, Dwosh I, Lindsey S, Pincus T, Wolfe F.  The American
College of Rheumatology 1991 Revised Criteria for the Classification of Global
Functional Status in Rheumatoid Arthritis.  Arthritis Rheum. 1992;35(5):498-502.

Product: ABP 710
Clinical Study Protocol: 20140111 
Date:  17 March 2017
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17.3
Appendix 3: American College of Rheumatology Core Set 
Measurements
American College of Rheumatology (ACR) Core Set Measurements:

Tender joint count

Swollen joint count

Subject's Global Health Assessment

Investigator's Global Health Assessment

Subject's assessment of pain

Health Assessment Questionnaire – Disability Index (HAQ-DI)

CRP
Joints to be Assessed for Swelling and Tenderness
The joints to be assessed for tenderness (68 joints) and swelling (66 joints) consist of 
the following:

Temporomandibular joint

Sternoclavicular joint

Acromioclavicular joint

Shoulders*

Elbows*

Wrists*

Interphalangeal on digit 1*

Distal interphalangeal joints on digits 2 - 5

Proximal interphalangeal joints on digits 2 - 5*

Metacarpophalangeal joints on digits 1 - 5*

Hips (tenderness only)

Knees*

Ankles

Metatarsals

Interphalangeal joints on toes 1 - 5

Metatarsophalangeal joints on toes 1 - 5
Joints assessed for swelling are the same, with the exception of the hips, which are 
excluded.
* The 28 joints used to calculate the DAS28.

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Date:  17 March 2017
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17.4
Appendix 4: Subjective Assessment Scales
Subject's Assessment of Disease Related Pain:
The subject's assessment of their current level of pain on a 100-mm horizontal VAS.  
The left-hand extreme of the line should be described as "no pain at all" and the right-
hand extreme as "worst pain imaginable."
Subject's Global Health Assessment:
The subject's overall assessment of their disease activity in the past week on a
100 mm VAS.  The left-hand extreme of the scale will be described as "no RA activity 
at all" (symptom-free and no arthritis symptoms) and the right-hand extreme as "worst
RA activity imaginable" (maximum arthritis disease activity).
Investigator's Global Health Assessment:
The investigator's assessment of the subject's current disease activity on a 100-mm
VAS.  The left-hand extreme of the scale will be described as "no activity at all"
(symptom-free and no arthritis symptoms) and the right-hand extreme as "worst activity
imaginable" (maximum arthritis disease activity).
Health Assessment Questionnaire-Disability Index
The HAQ-DI is a questionnaire on which subjects are asked to rate their level of
difficulty on daily activities (dressing and grooming, arising, eating, and walking) and
personal abilities (hygiene, reach, grip, and activity), as well as their use of aids,
devices, or help from another person for these activities and disabilities.

Product: ABP 710
Clinical Study Protocol: 20140111
Date: 17 March 2017
Summary of Changes
Page 1 of 5
&RQILGHQWLDO
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68%-(&76:,7+02'(5$7(726(9(5(5+(80$72,'$57+5,7,6
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17 March 2017, version 2.0
6SRQVRU
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 US
&OLQLFDO5HVHDUFK2UJDQL]DWLRQ
PRA Health Sciences
4130 ParkLake Avenue, Suite 400 
Raleigh, NC 27612 US
0HGLFDO0RQLWRU0HGLFDO([SHUW
, MD
Medical Director (Internal Medicine)
PRA Health Sciences
6DIHW\&RQWDFWV
North America/Latin and South America 
Phone:
1-800-772-2215/1-434-951-3489 
FAX:
1-888-772-6919/1-434-951-3482
E-mail:
CHOSafety@PRAIntl.com
Europe, Asia, and Pacific Region 
Phone:
+49.621.8782.154
FAX:
+44 1792 525 720
E-mail:
CHOSafety@PRAIntl.com
This study will be conducted in compliance with the protocol, Good Clinical Practice (GCP) 
as set forth in the International Council for Harmonisation (ICH) guidelines on GCP (ICH 
E6), and applicable local regulatory requirements.
&21),'(17,$/
This document is a confidential communication of Amgen Inc. Acceptance of this document constitutes 
agreement by the recipient that no unpublished information contained herein shall be published or disclosed 
without prior written approval, except that this document may be disclosed to the appropriate Institutional 
Review Board(s)/Independent Ethics Committee(s) under the condition that they keep it confidential.
PPD
PPD

Product: ABP 710
Clinical Study Protocol: 20140111
Date: 17 March 2017
Summary of Changes
Page 2 of 5
Confidential
Rationale:
This amendment is issued to make the following changes:

Clarify the premedication requirement.

Specify that subjects who are unable to make the week 22 visit within the allowed 
window are discontinued from the study. These subjects should return for an end of 
study visit to complete the end-of-study assessments within 28 days, if possible.

Specify that restrictions on pre-assessment analgesics apply to the baseline visit, in 
addition to subsequent on-treatment visits, and to clarify the restrictions.

Specify that joint assessments at the baseline visit be performed before 
randomization.

Require that subjects who cannot complete the screening procedures within 28 days 
before baseline will be considered screen failures. These subjects can be 
rescreened, and they may be rescreened under the same informed consent form if 
rescreening occurs within 30 days.

Remove “adverse events” from the list of examples of “Reasons for removal of a 
subject from the study.”  Subjects who discontinue treatment because of adverse 
events are encouraged to stay on study for continued assessment.

Emphasize that post-treatment PK samples are required to be collected within 
10 minutes after the end of infusion.

Specify that 95% confidence intervals (CIs), in addition to 90% CIs, will be presented 
for efficacy endpoints.

Clarify the inclusion and exclusion criteria.

Minor editorial corrections and clarifications were made.  These changes are not 
included in the summary below.
Summary of Changes:
Synopsis page 4, Section 8.1, Overall Study Design and Plan, page 24
Add
Subjects who are unable to complete the week 22 visit within the visit window of 
± 3 days will be discontinued from the study.  These subjects should return for an 
end-of-study visit to complete the end-of-study assessments within 28 days, if 
possible.
The last treatment for all subjects who do not discontinue early will be at… 
Synopsis page 5, Section 8.4.1, Inclusion Criteria, page 26
Add
6. Subject has at least one of the following: a positive rheumatoid factor or anti-cyclic 
citrullinated peptide (CCP) at screening.

Product: ABP 710
Clinical Study Protocol: 20140111
Date: 17 March 2017
Summary of Changes
Page 3 of 5
Confidential
Synopsis page 5, Section 8.4.1, Inclusion Criteria, page 26
Add (before criterion 11)
Subject must meet any 1 of the following 3 criteria:
Synopsis page 7, Section 8.4.2, Exclusion Criteria, page 29
Change
16. Subject has prior use of 2 or more distinct biologic therapies for RA.
Synopsis page 7, Section 8.4.2, Exclusion Criteria, page 30
Change
24. … adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo-
Provera® (medroxyprogesterone) injections, or contraceptive implants, or other 
effective methods)...
Section:  Synopsis Statistical Methods, page 9; 12.6.4, Efficacy, page 64
Add:
In addition to the 90% CI, the 95% CI for all primary and secondary efficacy endpoints 
will also be provided descriptively.
Section 8.4.3.1, Criteria for Subject Withdrawal, page 31
Add (under Reasons for removal from protocol-required investigational products or 
procedural assessments)
•
inability to complete the week 22 visit within the allowed visit window 
…
Subjects who discontinued treatment because of inability to complete the week 22 
visit within the allowed visit window should return for an end-of-study visit to 
complete the end-of-study assessments within 28 days, if possible.
…
•
adverse event
Section 8.5.1, Treatments Administered, pages 32-33; 9.2, Baseline (Day 1, first day of 
treatment, Week 0) page 46
Change
Premedications should must be given.  Premedications should be given selected 
according to local practice and/or the approved product label.  These medications 
should generally include acetaminophen, an antihistamine, and methylprednisone 

Product: ABP 710
Clinical Study Protocol: 20140111
Date: 17 March 2017
Summary of Changes
Page 4 of 5
&RQILGHQWLDO
100 mg IV or equivalent DSSUR[LPDWHO\ 30 minutes before each infusion EXWVKRXOGEH
VHOHFWHGDFFRUGLQJWRWKHLQGLYLGXDOVXEMHFW¶V QHHGV.
Section 8.5.5.2, Study Treatment Accountability, page 35
Change
All supplies of investigational product will be accounted for in accordance with GCP.  
There will be an individual study drug accountability record for each subject 7KHUHZLOO
EHDPDVWHUVWXG\GUXJDFFRXQWDELOLW\UHFRUGFRPSOHWHG and the pharmacist,…
The investigator RUGHVLJQHH will administer the investigational product…
Section 8.5.7.3, Rescue Medication, page 37 
Add (last 3 bullets)
(ie, at EDVHOLQHDQG weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50)
Change (third bullet)
•
NSAIDs/cyclooxygenase-2 (COX-2) inhibitors…
In all cases, WKHVHDJHQWVZLOO any dose regimen higher than the baseline dose is 
not EH allowed within 12 hours before clinical efficacy assessments… 
Table 8-1, pages 40-41
Add (heading for the “screening” column)
Screening
GD\V
Table 8-1, footnote j, page 41
Add

Section 9.1.1, Screen Failures, page 45
Change
,IDVXEMHFWKDVQRWPHWDOOHOLJLELOLW\FULWHULDDWWKHHQGRIWKHVFUHHQLQJSHULRGWKH
VXEMHFWZLOOEHUHJLVWHUHGDVDVFUHHQIDLOSubjects determined to be screen failures 
will not be eligible for immediate participation and must be registered as a screen failure 
in IXRS.  Laboratory assessments used…
…(ie, a total of 3 screens including initial screening).  ,IVFUHHQLQJSURFHGXUHVFDQQRW
EHFRPSOHWHGZLWKLQ GD\VEHIRUHGD\WKHVXEMHFWZLOOEHFRQVLGHUHGDVFUHHQ
CCI

Product: ABP 710
Clinical Study Protocol: 20140111
Date: 17 March 2017
Summary of Changes
Page 5 of 5
Confidential
failure but may be eligible for rescreening.  These subjects can be rescreened 
under the same ICF if rescreening occurs within 30 days of initial consent date.  
The subject will retain the same subject identification number…
Section 9.2, Baseline (Day 1, first day of treatment, Week 0), page 45
Add
•
baseline joint assessments (ACR and DAS tender/swollen joint counts; 
Section 17.3); the baseline joint assessment must be performed before
randomization
Section 12.4, Randomization, page 62
Add
Subjects unable to complete the week 22 visit within the allowed window will not 
be re-randomized and will be discontinued from the study.
Section:  Global
Replace:
Version date
27 April 2016
With:
17 March 2017