Clinical trial NCT01860976
Conditions: Psoriatic Arthritis
Sponsor: Bristol-Myers Squibb
Start date: 2013-06-17; Completion date: 2020-06-30
Enrollment: 489 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of psoriatic arthritis

Detailed description:
ASTRAEA=Active PSoriaTic ARthritis RAndomizEd TriAl

Arms: arm 1: Abatacept 125 mg/syringe (125 mg/mL) solution subcutaneously once a week for 168 days double blind/197 days open label/365 days long term extension arm 2: Placebo matching with Abatacept 0 mg solution subcutaneously once a week 168 days double blind
Interventions: intervention 1: Abatacept intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf: 


Clinical Protocol
IM101332
BMS-188667
Abatacept
Revised Protocol No.:03
Date: 19-Aug-2014
2
be kept in confidence in the same manner as the contents of this document. Any person 
who receives this document without due authorization from BMS is requested to return it 
to BMS or promptly destroy it. All other rights reserved. References to BMS in this
protocol may apply to partners to which BMS has transferred obligations, eg, a Contract 
Research Organization (CRO).
Replace all previous version(s) of the protocol with this revised protocol and please provide a 
copy of this revised protocol to all study personnel under your supervision, and archive the 
previous versions.








Clinical Protocol
IM101332
BMS-188667
Abatacept
SYNOPSIS
Clinical Protocol IM101332
Protocol Title: A Phase 3 Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 
Abatacept Subcutaneous Injection in Adults with Active Psoriatic Arthritis
Investigational Product(s), Dose and Mode of Administration, Duration of Treatment with Investigational 
Product(s):

Abatacept 125 mg weekly via SC injection

Placebo to match the abatacept weekly via SC injection
Study Phase: Phase 3
Research Hypothesis:
Abatacept 125 mg when administered SC is more effective than placebo in achieving ACR20 response after 
24 weeks (Day 169) of treatment in subjects with active Psoriatic Arthritis (PsA).
Objectives:
Primary: To compare the efficacy of abatacept to placebo as assessed by the ACR20 response at Day 169.
Key Secondary:

To compare the efficacy of abatacept to placebo as assessed by the Health Assessment Questionnaire 
(HAQ) response at Day 169.

To compare the efficacy of abatacept to placebo in the subset of subjects who have never been exposed to 
Tumor Necrosis Factor α Inhibitor (TNFi) therapy, as assessed by the ACR20 response at Day 169.

To compare the efficacy of abatacept to placebo in the subset of subjects who have previously taken TNFi 
therapy, as assessed by the ACR20 response at Day 169.

To compare the efficacy of abatacept to placebo as assessed by the proportion of subjects who do not show 
progression by the PsA modified SHS (Sharp/van der Heidje score) of x-rays from baseline to Day 169.
Study Design: This is a 24 week (168 days), Phase 3, randomized, double-blind, placebo controlled, multicenter 
study, followed by a 28 week (196 days) open-label period in subjects with active PsA based on the Classification 
Criteria for Psoriatic Arthritis (CASPAR). This study will include subjects who have had an inadequate response 
and/or intolerance to non-biologic DMARDs and may or may not been exposed to TNFi therapy. Subjects currently 
on biologic therapy cannot be enrolled. Approximately 400 subjects in total will be randomized in a 1:1 ratio to 
125 mg SC weekly of abatacept and placebo (200 subjects per arm): approximately 248 subjects in the TNFi 
exposed subgroup and approximately 152 subjects in the TNFi naive subgroup. Randomization will be stratified 
globally by current MTX use, prior use of TNFi therapy and for psoriatic skin involvement 3% BSA. A maximum 
of approximately 40% of subjects with < 3% BSA psoriatic skin involvement will be randomized. On Day 113 
subjects who do not achieve a 20% improvement from baseline in their swollen and tender joint counts will be 
labeled as treatment failures and removed from their blinded treatment arm and transitioned to the early escape arm, 
open label weekly SC abatacept 125 mg. At Day 169, all subjects will transition to the open-label phase and receive 
abatacept 125 mg SC weekly. At the end of the open label period, subjects have the option of entering a one year 
study extension.
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Date: 19-Aug-2014
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Clinical Protocol
IM101332
BMS-188667
Abatacept
Study Design: 
Study Population: Subjects with active PsA based on the Classification Criteria for Psoriatic Arthritis (CASPAR)
Key Inclusion Criteria:

Subjects at least 18 years of age who have a diagnosis of PsA by Classification Criteria for Psoriatic 
Arthritis (CASPAR)

Subjects have active PsA as shown by a minimum of 3 swollen joints and 3 tender joints (66/68 joint 
counts) at screening and randomization/Day 1 (prior to study drug administration). At least one of the 
swollen joints must be in the digit of the hand or foot.

Subjects with at least one confirmed 2 cm target lesion of plaque psoriasis in a region of the body that can 
be evaluated at screening and randomization/Day 1.

Subjects must have had an inadequate response or intolerance to at least one non-biologic disease-
modifying anti-rheumatic drug (DMARD).

If currently on a non-biologic DMARD (methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) 
the medication must have been used for at least 3 months with a stable dose for at least 28 days prior to 
randomization (Day 1). 

Subjects may have been exposed to TNFi therapy. Subjects may have discontinued for any reason 
(inadequate response, intolerance or other).

If using oral corticosteroids (10 mg mg/day prednisone equivalent), dose must be stable 14 days prior 
to randomization (Day 1).

Subjects may enroll on systemic retinoids (eg, acitretin) provided the medication has been used for at least 
3 months with a stable dose for at least 28 days prior to randomization (Day 1).
Key Exclusion Criteria

Subjects with guttate, pustular, or erythrodermic psoriasis

Subjects who have had prior exposure to abatacept (CTLA 4Ig)

Subjects who have been exposed to any investigational drug within 4 weeks or 5 half lives prior to 
randomization (Day 1), whichever is longer
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Clinical Protocol
IM101332
BMS-188667
Abatacept

Female subjects who had a breast cancer screening procedure that is suspicious for malignancy, and in 
whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory 
or other diagnostic evaluations

Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured 
by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing. Subjects 
with carcinoma in situ, treated with definitive surgical intervention prior to study enrollment are allowed.

Subjects with any bacterial infection within the last 60 days prior to screening (enrollment), unless treated 
and resolved with antibiotics, or any chronic bacterial infection (such as chronic pyelonephritis, 
osteomyelitis and bronchiectasis

Subjects at risk for tuberculosis (TB). Specifically, subjects with:
o
Current clinical, radiographic or laboratory evidence of active TB
o
A history of active TB within the last 3 years even if it was treated
o
A history of active TB greater than 3 years ago unless there is documentation that the prior anti-
TB treatment was appropriate in duration and type
o
Latent TB which was not successfully treated
o
Subjects with a positive TB screening test indicative of latent TB will not be eligible for the study 
unless they have no evidence of current TB on chest x-ray at screening and they are actively being 
treated for TB with isoniazid (INH) or other therapy for latent TB given according to local health 
authority guidelines (eg, Center for Disease Control). Treatment must have been given for at least 
4 weeks prior to randomization (Day 1). These subjects should complete treatment according to 
local health authority guidelines.

Subjects with herpes zoster that resolved less than 2 months prior to enrollment

Subjects with evidence (as measured by the investigator) of active or latent bacterial, active viral, or serious 
latent viral infections at the time of enrollment, including subjects with evidence of Immunodeficiency 
Virus (HIV) infection

Subjects who are not currently treated with a non-biologic DMARD and have clinical or radiographic 
evidence of arthritis mutilans (eg, digital telescoping or “pencil-in-cup” radiographic changes)

Subjects who have failed more than 2 TNFis due to inefficacy, with inefficacy defined as inadequate 
response after 3 months of treatment at a therapeutic dose:  NOTE:  There is no limit on the total number of 
TNFis to which the subject has been exposed.

Subjects who have received TNFi therapy within 4 weeks for etanercept, 8 weeks for adalimumab, 
certolizumab, infliximab or golimumab prior to randomization (Day 1).

Subjects who have received apremilast within 4 weeks, ustekinumab within 20 weeks, and briakinumab 
within 8 weeks prior to randomization (Day 1).

Subjects who have discontinued a non-biologic DMARD or systemic retinoid within four weeks or five 
half-lives, whichever is longer, prior to randomization (Day 1)

Use of any of the following within 28 days or five half lives whichever is longer prior to randomization 
(Day 1): azathioprine, cyclosporine A, oral tacrolimus, mycophenolate mofetil (MMF), hydroxyurea, 
fumaric acid esters, paclitaxel, 6-thioguanine, 6-mercatopurine, or tofacitinib 
Study Assessments: 
Efficacy will be assessed using the ACR response rate, the HAQ response rate, the radiographic non-progressor rate 
of the PsA-modified Sharp/van der Heidje score (SHS), and the Psoriasis Area and Severity Index (PASI) scores. 
Statistical Considerations:
Sample Size: A hierarchical testing procedure will be applied for the primary endpoint (proportion of ACR20 
responders at Day 169) and the 4 key secondary endpoints (proportion of HAQ responders, proportion of ACR20 
responders in 2 subgroups and proportion of non-progressors in total SHS at Day 169) to ensure the preservation of 
the overall type I error. The sample size determination is calculated in such a way that the power is at least 80% for 
Revised Protocol No.: 03
Date: 19-Aug-2014
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Clinical Protocol
IM101332
BMS-188667
Abatacept
each of the endpoints included in the hierarchical testing procedure and in addition, for the skin endpoint, PASI50.
All estimates used for the sample size determination are based on the results of phase II study IM101158 for PsA, 
except for non-progressors using total PsA-modified Sharp/van der Heijde score (SHS) (x-ray). A 2-sided continuity 
corrected Chi-square test at alpha=0.05 is used. Based on the power calculations, a sample size of 400 randomized 
subjects (200 per arm) is required: 248 subjects in the TNFi exposed subgroup and 152 subjects in the TNFi naive 
subgroup.
Endpoints:
Primary endpoint: Proportion of ACR20 responders at Day 169
Key secondary endpoints:

Proportion of HAQ responders (a reduction of at least 0.35 from baseline) at Day 169

Proportion of ACR20 responders at Day 169 in the TNFi naive subpopulation

Proportion of ACR20 responders at Day 169 in the TNFi exposed subpopulation

Proportion of non-progressors in total PsA-modified SHS (defined as a change from baseline in total 
PsA-modified SHS 0) at Day 169
Other secondary endpoint:

Proportion of subjects achieving a PASI50 (achieving at least 50% improvement from baseline in PASI) at 
Day 169 in subjects with baseline BSA 3% 

Proportion of ACR50 and ACR70 responders at Day 169

Mean change from baseline in physical (PCS) and mental functions (MCS) of SF-36 at Day 169

Proportions of subjects with positive immunogenicity response up to Day 169

Safety (proportion of subjects with adverse events, deaths, SAEs, and AEs leading to discontinuation and 
proportion of subjects with marked laboratory abnormalities) up to Day 169
Analyses: 
Efficacy Analysis:
All efficacy analyses will be for the intent-to-treat (ITT) analysis population. In general, no formal statistical testing 
will take place except for the primary, the key secondary efficacy endpoints and the proportion of subjects achieving 
PASI50 at Day 169. If the 2-sided test for the primary endpoint (proportion of ACR20 responders at Day 169) is 
statistically significant at alpha=5%, then a hierarchical approach for statistical testing will be used for the secondary 
endpoints. This procedure allows for preserving of the overall Type I error rate of 0.05 for the study. Hierarchical 
ordering of the secondary endpoints is as follows:

Proportion of HAQ responders at Day 169 

Proportion of ACR20 responders at Day 169 in the TNFi naive subpopulation 

Proportion of ACR20 responders at Day 169 in the TNFi exposed subpopulation 

Proportion of non-progressors in total PsA-modified SHS (defined as a change from baseline in total 
PsA-modified SHS 0) at Day 169 
P-values will be presented for each of these endpoints. However, no claim will be based on endpoints that have a 
rank lower than that endpoint whose null hypothesis was the first that could not be rejected. That is, no claim will be 
based on endpoints that have a rank lower than that endpoint whose test was the first to be non-statistically 
significant. A clear distinction will be made between p-values whereby claims can and cannot be made. All 
proportions mentioned above will be tested with a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test, 
stratified by prior TNFi use (Yes, No), MTX use (Yes, No) and BSA (< 3%, 3%) at a 5% significance level.
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Clinical Protocol
IM101332
BMS-188667
Abatacept
 
 
 
 
 
 
2
ETHICAL CONSIDERATIONS
2.1
Good Clinical Practice
This study will be conducted in accordance with Good Clinical Practice (GCP), as defined by the 
International Conference on Harmonisation (ICH) and in accordance with the ethical principles 
underlying European Union Directive 2001/20/EC and the United States Code of Federal 
Regulations, Title 21, Part 50 (21CFR50).
The study will be conducted in compliance with the protocol. The protocol and any amendments 
and the subject informed consent will receive Institutional Review Board/Independent Ethics 
Committee (IRB/IEC) approval/favorable opinion prior to initiation of the study.
All potential serious breaches must be reported to Bristol-Myers Squibb (BMS) immediately. A 
serious breach is a breach of the conditions and principles of GCP in connection with the study 
or the protocol, which is likely to affect, to a significant degree, the safety or physical or mental 
integrity of the subjects of the study or the scientific value of the study.
Study personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective tasks.
This study will not use the services of study personnel where sanctions have been invoked or 
where there has been scientific misconduct or fraud (eg, loss of medical licensure, debarment). 
2.2
Institutional Review Board/Independent Ethics Committee 
Before study initiation, the investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, consent form, subject recruitment materials 
(eg, advertisements), and any other written information to be provided to subjects. The 
investigator or BMS should also provide the IRB/IEC with a copy of the Investigator Brochure 
or product labeling information to be provided to subjects and any updates. 
The investigator or BMS should provide the IRB/IEC with reports, updates and other 
information (eg, expedited safety reports, amendments, and administrative letters) according to 
regulatory requirements or institution procedures.
2.3
Informed Consent
Investigators must ensure that subjects are clearly and fully informed about the purpose, potential 
risks, and other critical issues regarding clinical studies in which they volunteer to participate. 
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Clinical Protocol
IM101332
BMS-188667
Abatacept
In situations where consent cannot be given to subjects, their legally acceptable representatives 
are clearly and fully informed about the purpose, potential risks, and other critical issues 
regarding clinical studies in which the subject volunteers to participate.
BMS will provide the investigator with an appropriate (ie, Global or Local) sample informed 
consent form which will include all elements required by ICH, GCP and applicable regulatory 
requirements. The sample informed consent form will adhere to the ethical principles that have 
their origin in the Declaration of Helsinki.
Investigators must:
1) Provide a copy of the consent form and written information about the study in the 
language in which the subject is most proficient prior to clinical study participation. The 
language must be non-technical and easily understood. 
2) Allow time necessary for subject or subject's legally acceptable representative to inquire 
about the details of the study.
3) Obtain an informed consent signed and personally dated by the subject or the subject's 
legally acceptable representative and by the person who conducted the informed consent 
discussion. 
4) Obtain the IRB/IEC’s written approval/favorable opinion of the written informed consent 
form and any other information to be provided to the subjects, prior to the beginning of 
the study, and after any revisions are completed for new information.
5) If informed consent is initially given by a subject’s legally acceptable representative or 
legal guardian, and the subject subsequently becomes capable of making and 
communicating his or her informed consent during the study, consent must additionally 
be obtained from the subject.
6) Revise the informed consent whenever important new information becomes available that 
is relevant to the subject's consent. The investigator, or a person designated by the 
investigator, should fully inform the subject or the subject's legally acceptable 
representative or legal guardian, of all pertinent aspects of the study and of any new 
information relevant to the subject's willingness to continue participation in the study. 
This communication should be documented. 
The confidentiality of records that could identify subjects must be protected, respecting the 
privacy and confidentiality rules applicable to regulatory requirements, the subjects' signed ICF 
and, in the US, the subjects’ signed HIPAA Authorization.
The consent form must also include a statement that BMS and regulatory authorities have direct 
access to subject records. 
The rights, safety, and well-being of the study subjects are the most important considerations and 
should prevail over interests of science and society.
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Clinical Protocol
IM101332
BMS-188667
Abatacept
3
INVESTIGATIONAL PLAN
3.1
Study Design and Duration
This is a 24 week (168 days), Phase 3, randomized, double-blind, placebo controlled, multicenter 
study, followed by a 28 week (196 days) open-label period in subjects with active PsA based on
the Classification Criteria for Psoriatic Arthritis (CASPAR) (Appendix 1). This study will 
include subjects who have had an inadequate response or intolerant response to non-biologic 
DMARDs and may or may not have had been exposed to TNFi therapy. Subjects currently on 
biologic therapy cannot be enrolled.
Approximately 400 subjects in total will be randomized in a 1:1 ratio to 125 mg SC weekly of 
abatacept and placebo (200 subjects per arm), approximately 248 subjects (124 subjects per arm) 
in the TNFi exposed subgroup and approximately 152 subjects (76 subjects per arm) in the TNFi 
naïve subgroup. Randomization will be stratified globally by current MTX use, prior use of TNFi
therapy and for psoriatic skin involvement 3% BSA. An approximate maximum of 40% of 
subjects with < 3% BSA psoriatic skin involvement will be randomized. Once enrollment 
maximums for TNFi exposure and % BSA subgroups have been reached, randomization of 
additional subjects in these subgroups may be closed.
On Day 113 subjects who do not achieve a 20% improvement from baseline (Day 1) in their 
swollen and tender joint counts will be labeled as treatment failures and removed from their 
blinded treatment arm and transitioned to the early escape arm, open label weekly SC abatacept 
125 mg. At Day 169, all subjects will transition to the open-label period and receive abatacept 
125 mg SC weekly. At the end of open label period, subjects have the option of entering a one 
year long term extension.
Figure 3.1-1:
Study Design Schematic
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Clinical Protocol
IM101332
BMS-188667
Abatacept
3.1.1
Screening
Eligibility will be based on specified Inclusion/Exclusion Criteria. Information on medical 
history and concomitant medications will be determined and safety assessments will be 
performed. Randomization must occur within 28 days of the qualifying screening visit. An 
optional Screening Visit 2 will be performed if >28 days (but 56 days) has elapsed since 
Screening Visit 1 prior to randomization. For example, if a subject qualified for the study but 
requires additional time to stabilize on existing therapies or the site has not received results from 
all the relevant laboratory testing within the 28 day window, the subject could be rescreened. A 
rescreened subject must be randomized within 28 days. 
3.1.2
Double-Blind Period 
Following screening, eligible subjects will be randomized to either abatacept 125 mg SC weekly 
or placebo.
No change of psoriasis or PsA therapeutic regimen is allowed during the double period except 
for intolerance based on investigator judgment (other than rescue therapy in Section 3.1.2.1).
3.1.2.1
Rescue Therapy (Day 1 Baseline to Day 169)
At any time from baseline to Day 169 except for the 28 days prior to Day 113 or Day 169, rescue 
therapy may be considered for exacerbation of psoriatic arthritis disease activity.
For psoriatic arthritis, only one instance of rescue therapy may be given during the double-blind
period. This may occur at a regularly scheduled study visit or between study visits. Permitted 
therapy for psoriatic arthritis is as follows:

A single oral tapering dose of glucocorticosteroid (no greater than 40 mg of prednisone 
[or prednisone equivalent]) per day, not to exceed 2 weeks

An intra-articular dose of glucocorticoids (no greater than 40 mg methylprednisolone or 
40 mg of triamcinolone [or methylprednisolone or triamcinolone equivalent] into one joint or 
divided into two joints

A single intramuscular dose of glucocorticoids (no greater than 40 mg methylprednisolone or 
40 mg of triamcinolone [or methylprednisolone or triamcinolone equivalent])

An entheseal injection with glucocorticosteroid (no greater than 40 mg methylprednisolone 
or 40 mg of triamcinolone [or methylprednisolone or triamcinolone equivalent]) into one 
entheseal site or divided into two entheseal sites
For the treatment of psoriasis in subjects not currently using low potency topical corticosteroids, 
low potency topical corticosteroids [potency group VI (eg, desonide 0.5%, or equivalent) or 
potency group VII (eg, hydrocortisone 1%, or equivalent) for palms, soles, face, and 
intertriginous areas (where two skin areas rub together) may be initiated.
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Abatacept
3.1.2.2
Early Escape (Day 113)
On Day 113, subjects who do not achieve a ≥20% improvement from baseline in their swollen 
and tender joint counts will be labeled as treatment failures and removed from their blinded 
treatment arm and transitioned to "Early Escape" treatment with open label weekly SC abatacept 
125 mg. In addition to all Day 113 procedures, these subjects will perform the additional 
procedures of the Early Escape Visit. 
3.1.3
Open Label [Day 169 (Open Label Day1) to Day 365 (Open Label Day 
197)]
Subjects will remain on open-label abatacept 125 mg SC until Day 365. Permitted changes in 
treatment are described in the following sections (Section 3.1.3.1 and 3.1.3.2).
3.1.3.1
Increases in Medication to Manage Increased Disease Activity in the 
Open Label Period
Psoriatic Arthritis
For increased arthritis disease activity that in the opinion of the investigator requires additional 
treatment, the following hierarchy of treatments should be followed.
1. NSAIDs may be added or the dose thereof may be increased according to labeling guidelines 
as determined by patient tolerance.
2. The dose of currently prescribed concomitant non-biologic DMARD therapy should be 
increased according to labeling guidelines as determined by patient tolerance.
3. Short-courses of therapy with glucocorticosteroids may be used up to two times during the 
open-label period as follows:
a.
An oral tapering dose of glucocorticosteroid (no greater than 40 mg of prednisone 
[or prednisone equivalent]) per day, not to exceed 2 weeks
b. An intra-articular dose of glucocorticoids (no greater than 40 mg methylprednisolone or 
40 mg of triamcinolone [or methylprednisolone or triamcinolone equivalent] into one 
joint or divided into two joints
c.
A 
single 
intramuscular 
dose 
of 
glucocorticoids 
(no 
greater 
than 
40 mg 
methylprednisolone or 40 mg of triamcinolone [or methylprednisolone or triamcinolone
equivalent])
d. An 
entheseal 
injection 
with 
glucocorticosteroid 
(no 
greater 
than 
40 mg 
methylprednisolone or 40 mg of triamcinolone [or methylprednisolone or triamcinolone
equivalent]) into one entheseal site or divided into two entheseal sites
NOTE:
Daily doses of glucocorticosteroids should not be increased and not exceed 10 mg 
prednisone (or equivalent) during the open label period.
4. After maximizing NSAIDs and current non-biologic DMARD therapy and utilizing options 
for glucocorticosteroid therapy, permitted non-biologic DMARD may be initiated per 
investigator judgment according to labeling guidelines.
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Clinical Protocol
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Abatacept
 
 
3.2
Post Study Access to Therapy
At the end of the study, BMS will not continue to supply study drug to subjects/investigators 
unless BMS chooses to extend the study. The investigator should ensure that the subject receives 
appropriate standard of care to treat the condition under study.
3.3
Study Population
For entry into the study, the following criteria MUST be met.
3.3.1
Inclusion Criteria
1) Signed Written Informed Consent
a) Subject is willing to participate in the study and signed the informed consent
2) Target Population
a) Subjects have a diagnosis of PsA by Classification Criteria for Psoriatic Arthritis 
(CASPAR) (Appendix 1) 
b) Subjects have at least one confirmed 2 cm target lesion of plaque psoriasis in a region 
of the body that can be evaluated excluding the axilla, genitals, groin, palms, and soles at 
screening and randomization/Day 1.
c) Subjects must have had an inadequate response or intolerance to at least one non-biologic 
disease-modifying anti-rheumatic drug (DMARD)
NOTE: Inadequate response to a non-biologic DMARD is defined as prior 
treatment with MTX, leflunomide, or sulfsalazine at a therapeutic dose for at least 
3 months (For MTX, therapeutic dose is define as at least 15 mg weekly), that
was discontinued for lack of efficacy or was associated with ongoing active 
disease.
Intolerance to a non-biologic DMARD is defined as discontinuation or dose 
limitation due to an adverse event.
d) Subjects may have been exposed to TNFi therapy. Subjects may have discontinued for 
any reason (inadequate response, intolerance or other).
NOTE: Inadequate response to TNFi therapy is defined as prior treatment with a 
TNFi at an approved dose for at least 3 months, which was discontinued for lack 
of efficacy or was associated with ongoing active disease.
Intolerance to a TNFi is defined as discontinuation or dose limitation due to an 
adverse event.
e) Subjects have active disease as shown by a minimum of 3 swollen joints and 3 tender 
joints (66/68 joint counts) at screening and randomization/Day 1 (prior to study drug 
administration). At least one of the swollen joints must be in the digit of the hand or foot. 
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f)
If currently on a non-biologic DMARDs [methotrexate (maximum of 25 mg weekly), 
leflunomide, sulfasalazine, or hydroxychloroquine], the medication must have been used 
for at least 3 months with a stable dose for at least 28 days prior to randomization 
(Day 1).
g) NSAIDs doses must be stable for at least 14 days before randomization (Day 1) and 
consistent with labeling recommendations. 
h) If using oral corticosteroids (10 mg/day prednisone equivalent), dose must be stable 
14 days before randomization (Day 1).
i)
Subjects may enroll on systemic retinoids (eg, acitretin) provided the subject has used the 
medication for at least 3 months with a stable dose at least 4 weeks prior to 
randomization (Day 1).
j)
Concurrent topical therapy for plaque psoriasis must have been stable for 14 days prior 
to randomization (Day 1).
k) Subject Re-enrollment: This study permits the re-enrollment of a subject that has 
discontinued the study as a pre-treatment failure (ie subject has not been randomized). If 
re-enrolled, the subject must be re-consented.
3) Age and Reproductive Status
See Section 3.3.3 for the definition of WOCBP.
a) Men and women, at least 18 years of age.
b) Women of childbearing potential (WOCBP) must use method(s) of contraception based 
on guidelines described in Appendix 2. The individual methods of contraception and 
duration should be determined in consultation with the investigator. 
c) Women must have a negative serum or urine pregnancy test (minimum sensitivity 
25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational 
product.
d) Women must not be breastfeeding
e) Women who are not of childbearing potential (ie, who are postmenopausal or surgically 
sterile; see Section 3.3.3 for the definition of WOCBP) do not require contraception
3.3.2
Exclusion Criteria
1) Target Disease Exceptions
a) Subjects with active systemic inflammatory condition other than PsA (eg, systemic lupus 
erythematosus).
2) Medical History and Concurrent Diseases
a) Subjects who are impaired, incapacitated, or incapable of completing study related 
assessments
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Clinical Protocol
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BMS-188667
Abatacept
b) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, 
gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease
including severe and uncontrolled infections, such as sepsis and opportunistic infections. 
Concomitant medical conditions that, in the opinion of the investigator, might place the 
subject at unacceptable risk for participation in this study
c) Female subjects who had a breast cancer screening procedure that is suspicious for 
malignancy, and in whom the possibility of malignancy cannot be reasonably excluded 
following additional clinical, laboratory or other diagnostic evaluations
d) Subjects with a history of cancer within the last 5 years (other than non-melanoma skin 
cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be 
removed prior to dosing. Subjects with carcinoma in situ, treated with definitive surgical 
intervention prior to study enrollment are allowed.
e) Subjects with a history of (within 12 months of signing informed consent), or known 
current problems with drug or alcohol abuse history or known cirrhosis including 
alcoholic cirrhosis
f)
Subjects with any bacterial infection within the last 60 days prior to screening 
(enrollment), unless treated and resolved with antibiotics, or any chronic bacterial 
infection (such as chronic pyelonephritis, osteomyelitis and bronchiectasis).
g) Subjects at risk for tuberculosis (TB). Specifically, subjects with:
i)
Current clinical, radiographic or laboratory evidence of active TB
ii) A history of active TB within the last 3 years even if it was treated
iii) A history of active TB greater than 3 years ago unless there is documentation that the 
prior anti-TB treatment was appropriate in duration and type
iv) Latent TB which was not successfully treated
v) Subjects with a positive TB screening test indicative of latent TB will not be eligible 
for the study unless they have no evidence of current TB on chest x-ray at screening 
and they are actively being treated for TB with isoniazid (INH) or other therapy for 
latent TB given according to local health authority guidelines (eg, Center for Disease 
Control). Treatment must have been given for at least 4 weeks prior to randomization 
(Day 1). These subjects should complete treatment according to local health authority 
guidelines.
h) Subjects with herpes zoster that resolved less than 2 months prior to enrollment
i)
Subjects with evidence (as measured by the investigator) of active or latent bacterial,
active viral, or serious latent viral infections at the time of enrollment, including subjects 
with evidence of Immunodeficiency Virus (HIV) infection
j)
Subjects with guttate, pustular, or erythrodermic psoriasis
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Date: 19-Aug-2014
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Clinical Protocol
IM101332
BMS-188667
Abatacept
k) Subjects who have a history of systemic fungal infections (such as histoplasmosis, 
blastoplasmosis, or coccidioides)
l)
Subjects who fulfill ACR Functional Class 4 (Appendix 3)
m) Subjects who have had prior exposure to abatacept (CTLA4-Ig) or other CTLA4 
therapies.
n) Subjects who have been exposed to any investigational drug within 4 weeks or 
5 half-lives prior to randomization (Day 1), whichever is longer
o) Subjects who have received any live vaccines within 3 months of the study drug 
administration or are scheduled to receive live vaccines. (In view of the long half-life of 
abatacept, study subjects should not be administered a live virus vaccine for a minimum 
of 3 months following the last dose of study medication).
p) Subjects who are not currently treated with a non-biologic DMARD and have clinical or 
radiographic evidence of arthritis mutilans (eg, digital telescoping or “pencil-in-cup” 
radiographic changes).
q) Subjects who have discontinued a non-biologic DMARD or systemic retinoid within four 
weeks or five half-lives prior to randomization (Day 1) whichever is longer.
r)
Subjects who have discontinued oral corticosteroids within 14 days prior to 
randomization (Day 1).
s) Subjects who have received an IM, IV or IA administration of a corticosteroid 28 days 
prior to randomization (Day 1)
t)
Subjects who have discontinued oral NSAIDs within 14 days prior to randomization 
(Day 1).
u) Subjects who have failed more than 2 TNFis due to inefficacy with inefficacy defined as 
inadequate response after 3 months of treatment at a therapeutic dose.  NOTE:  There is 
no limit on the total number of TNFi to which the subject has been exposed.
v) Subjects who have received TNFi therapy within 4 weeks for etanercept or within 
8 weeks for adalimumab, certolizumab, infliximab, or golimumab prior to randomization 
(Day 1).
w) Prior use of rituximab 6 months ago; if after > 6 months has elapsed since use, must 
have documented reconstitution of total peripheral B cell counts to a level within normal 
laboratory range.
x) Subjects who have been treated with apremilast within 4 weeks, ustekinumab within 
20 weeks, or briakinumab within 8 weeks prior to randomization(Day 1). 
y) Use of any of the following within 28 days or five half lives whichever is longer prior to 
randomization (Day 1): azathioprine, cyclosporine A, oral tacrolimus, mycophenolate 
mofetil (MMF), 
hydroxyurea, fumaric acid esters, paclitaxel, 6-thioguanine, 
6-mercatopurine, or tofacitinib 
z) Treatment with the following topical therapies within 14 days prior to randomization 
(Day 1): calcineurin inhibitors (tacrolimus and pimecrolimus), topical vitamin D analogs 
(eg, calcipotriene, calcitriol, tacalcitol), topical retinoids (eg, tazorotene), shampoo 
containing corticosteroids, topical tar and salicylic acid (except on the scalp), or medium 
to high potency corticosteroids (potency great than or equal to triamcinolone 0.1%).
Revised Protocol No.: 03
Date: 19-Aug-2014
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Clinical Protocol
IM101332
BMS-188667
Abatacept
aa) Treatment with phototherapy within 28 days prior to randomization.
3) Physical and Laboratory Test Findings 
a) Hepatitis B surface antigen-positive subjects with detectable hepatitis B viral DNA or 
Hepatitis B core antibody positive subjects and with detectable hepatitis B viral DNA
b) Hepatitis C antibody-with detectable hepatitis C viral RNA
c) Hemoglobin (Hgb) < 8.5 g/dl
d) White Blood Count (WBC) < 3,000/mm3 (3 x 109/L)
e) Platelets < 100,000/mm3 (100 x 109/L)
f)
Any laboratory test results that, in the opinion of the investigator, might place the subject 
at unacceptable risk for participation in this study
4) Allergies and Adverse Drug Reaction
a) Hypersensitivity to one of the investigational product excipients.
5) Sex and Reproductive Status
a) Women who are breast-feeding.
6) Other Exclusion Criteria
a) Prisoners or subjects who are involuntarily incarcerated 
b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical 
(eg, infectious disease) illness
c) Subjects who are illiterate
d) Subjects with a history or suspicion of unreliability, poor cooperation, or non-compliance 
with medical treatment.
Eligibility criteria for this study have been carefully considered to ensure the safety of the study 
subjects and that the results of the study can be used. It is imperative that subjects fully meet all 
eligibility criteria.
3.3.3
Women of Childbearing Potential
Women of childbearing potential (WOCBP) is defined as any female who has experienced 
menarche and who has not undergone surgical sterilization (hysterectomy or bilateral 
oophorectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in 
a woman over age 45 years in the absence of other biological or physiological causes. In 
addition, women under the age of 55 years must have a serum follicle stimulating hormone 
(FSH) level > 40 mIU/ml to confirm menopause.
Revised Protocol No.: 03
Date: 19-Aug-2014
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Clinical Protocol
IM101332
BMS-188667
Abatacept
Women treated with hormone replacement therapy, (HRT) are likely to have artificially 
suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH 
level. The duration of the washout period is a function of the type of HRT used: The duration of 
the washout period below are suggested guidelines and the investigators should use their 
judgment in checking serum FSH levels. If the serum FSH level is > 40 mIU/ml at any time 
during the washout period, the woman can be considered postmenopausal.
1 week minimum for vaginal hormonal products, (rings, creams, gels)
4 week minimum for transdermal products
8 week minimum for oral products
Other parenteral products may require washout periods as long as 6 months.
 
 
 
 
 
 
 
 
 
 
 
Revised Protocol No.: 03
Date: 19-Aug-2014
34


Clinical Protocol
IM101332
BMS-188667
Abatacept
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Revised Protocol No.: 03
Date: 19-Aug-2014
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Clinical Protocol
IM101332
BMS-188667
Abatacept

Significant non-compliance with protocol (ie, procedures, assessments, medication, etc). 
The investigator should discuss such issues with the BMS Medical Monitor.

Missed doses

During the double-blind period, any subject who misses greater than four
consecutive doses must be withdrawn from the study.

During the open-label period, any subject who misses greater than six consecutive 
doses must be withdrawn from the study.
If in the opinion of the investigator continued participation in the study is not in the best interest 
of the subject due to lack of sufficient benefit, the investigator should advise the subject to 
discontinue study treatment.
All subjects who discontinue should comply with protocol specified follow-up procedures as 
outlined in Section 5. The only exception to this requirement is when a subject withdraws 
consent for all study procedures or loses the ability to consent freely (ie, is imprisoned or 
involuntarily incarcerated for the treatment of either a psychiatric or physical illness).
If study treatment is discontinued prior to the subject’s completion of the study, the reason for 
the discontinuation must be documented in the subject’s medical records and entered on the 
appropriate case report form (CRF) page.
3.6
Post Treatment Study Follow-up
Subjects who discontinue study treatment may continue to be followed.
3.6.1
Withdrawal of Consent
Subjects who request to discontinue study treatment will remain in the study and must continue 
to be followed for protocol specified follow-up procedures. The only exception to this is when a 
subject specifically withdraws consent for any further contact with him/her or persons previously 
authorized by subject to provide this information. Subjects should notify the investigator of the 
decision to withdraw consent from future follow-up in writing, whenever possible. The 
withdrawal of consent should be explained in detail in the medical records by the investigator, as 
to whether the withdrawal is from further treatment with study drug only or also from study 
procedures and/or post treatment study follow-up, and entered on the appropriate CRF page. In 
the event that vital status (whether the subject is alive or dead) is being measured, publicly 
available information should be used to determine vital status only as appropriately directed in 
accordance with local law.
3.6.2
Lost to Follow-Up
All reasonable efforts must be made to locate subjects to determine and report their ongoing 
status. This includes follow-up with persons authorized by the subject as noted above. Lost to 
follow-up is defined by the inability to reach the subject after a minimum of three documented 
phone calls, faxes, or emails as well as lack of response by subject to one registered mail letter. 
Revised Protocol No.: 03
Date: 19-Aug-2014
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Clinical Protocol
IM101332
BMS-188667
Abatacept
All attempts should be documented in the subject’s medical records. If it is determined that the 
subject has died, the site will use permissible local methods to obtain the date and cause of death.
If investigator’s use of third-party representative to assist in the follow-up portion of the study 
has been included in the subject’s informed consent, then the investigator may use a 
Sponsor-retained third-party representative to assist site staff with obtaining subject’s contact 
information or other public vital status data necessary to complete the follow-up portion of the 
study. The site staff and representative will consult publicly available sources, such as public 
health registries and databases, in order to obtain updated contact information. If after all 
attempts, the subject remains lost to follow-up, then the last known alive date as determined by 
the investigator should be reported and documented in the subject’s medical records.
4
TREATMENTS
Study drugs include both Non-investigational (NIMP) and Investigational Medicinal Products 
(IMP) and can consist of the following:

All products, active or placebo, being tested or used as a comparator in a clinical trial. 

Study required premedication, and 

Other drugs administered as part of the study that are critical to claims of efficacy 
(eg, background therapy, rescue medications)

Diagnostic agents: (such as glucose for glucose challenge) given as part of the protocol 
requirements must also be included in the dosing data collection.
For all study sites, Bristol-Myers Squibb Research and Development will supply the following 
Investigational Product(s).
4.1
Study Treatments 
Double-Blind and Open Label Period: Abatacept (or matching placebo) will be administered 
subcutaneously (SC) once per week. Subjects will be trained by the investigational staff in 
self-administration and then proceed with independent self-administration.
Revised Protocol No.: 03
Date: 19-Aug-2014
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Clinical Protocol
IM101332
BMS-188667
Abatacept
Table 4.1-1:
Investigational Products
PRODUCT
ROUTE OF 
ADMINISTRATION
POTENCY
APPEARANCE
STORAGE 
CONDITIONS
Abatacept 
Injection
Subcutaneous
125 mg/syringe 
(125 mg/mL)
Clear to slightly 
opalescent, colorless 
to pale yellow 
solution, essentially 
free of particulate 
matter on visual 
inspection
Store refrigerated, 2-8 ° C 
(36-46 ° F); protect from 
light; protect from freezing
Placebo for 
Abatacept 
Injection
Subcutaneous
To match 125 
mg/syringe
Clear to slightly 
opalescent, colorless 
to pale yellow 
solution, essentially 
free of particulate 
matter on visual 
inspection
Store refrigerated, 2-8 ° C 
(36-46 ° F); protect from 
light; protect from freezing
4.1.1
Investigational Product
An investigational product, also known as investigational medicinal product in some regions, is 
defined a pharmaceutical form of an active substance or placebo being tested or used as a 
reference in a clinical study, including products already with a marketing authorization but used 
or assembled (formulated or packaged) differently than the authorized form, or used for an 
unauthorized indication, or when used to gain further information about the authorized form.
The investigational product should be stored in a secure area according to local regulations. It is 
the responsibility of the investigator to ensure that investigational product is only dispensed to 
study subjects. The investigational product must be dispensed only from official study sites by 
authorized personnel according to local regulations. 
In this protocol, investigational product(s) is/are:

Abatacept for subcutaneous injection, 125 mg/ml

Placebo to match Abatacept for subcutaneous injection, 125 mg/ml
4.1.2
Noninvestigational Product
Other medications used as support or escape medication for preventative, diagnostic, or 
therapeutic reasons, as components of the standard of care for a given diagnosis, may be 
considered as noninvestigational products. 
In this protocol, noninvestigational product(s) is/are not applicable for this study.
Revised Protocol No.: 03
Date: 19-Aug-2014
39


Clinical Protocol
IM101332
BMS-188667
Abatacept
4.1.3
Handling and Dispensing
The product storage manager should ensure that the study drug is stored in accordance with the 
environmental conditions (temperature, light, and humidity) as determined by BMS. If concerns 
regarding the quality or appearance of the study drug arise, the study drug should not be 
dispensed and contact BMS immediately.
Investigational product documentation must be maintained that includes all processes required to 
ensure drug is accurately administered. This includes documentation of drug storage, 
administration and, as applicable, storage temperatures, reconstitution, and use of required 
processes (eg, required diluents, administration sets).
For non-investigational product, if marketed product is utilized, it should be stored in accordance 
with the package insert, summary of product characteristics (SmPC), or similar.
4.2
Method of Assigning Subject Identification
At the time of enrollment, immediately after written informed consent is obtained and before 
performing any study-related procedures, each subject will be assigned a unique sequential 
subject number beginning with 001, 002, 003, etc, for identification throughout the study. Any 
subject number must not be reused for any other participant. The physician/coordinator must 
contact the Central Randomization System to enroll each subject into a centralized database at 
the time of signing consent.
After completion of all screening evaluations and concomitant adjustment or stabilization, all 
eligible subjects will enter the 24-week double-blind, Treatment Period. Subjects completing the 
double-blind period and fulfilling the necessary criteria may enter the 28-week open-label period 
during which all subjects receive abatacept 125 mg/ml subcutaneous injection. 
Randomization schedules will be generated and kept by the Randomization Group within Drug 
Supply Management of Bristol-Myers Squibb. Each subject who is qualified for treatment will 
be assigned a unique randomization number. Randomization numbers will be assigned using a 
Central Randomization System in the order in which subjects qualify for treatment, not in the 
order of study enrollment. Subjects will be randomized to abatacept SC or abatacept SC placebo 
in a 1:1 ratio. Randomization will be stratified globally by current MTX use, prior exposure to 
TNFi and whether plaque psoriasis involves 3% BSA. Enrollment will be limited to 
approximately 38% TNFi naïve subjects and approximately 40% subjects with < 3% BSA 
involvement with plaque psoriasis.
Specific instructions for randomization into the Central Randomization System will be provided 
in a separate manual.
4.3
Selection and Timing of Dose for Each Subject
Subjects will be trained to self-administer their weekly SC injection of study medication.
Training should be performed by investigational site personnel that are considered qualified 
trainers by the Investigator. Subjects will be trained using instructions that will be provided by 
Revised Protocol No.: 03
Date: 19-Aug-2014
40


Clinical Protocol
IM101332
BMS-188667
Abatacept
BMS. The subject should be able to self-administer the SC injection between office visits. If the 
subject is unable to self-administer the SC injection, a caregiver may administer the injection for 
the subject. Under these circumstances, the caregiver should be trained by the investigational 
staff and be present when the subject returns to the office. 
If a subject administers another SC medication (eg, SC MTX), then the study drug should be 
administered to a site on the left side of the body and the other SC medication to a site on the 
right side of the body.
On “Office Visit” days, SC injections should occur AFTER all assessments, including blood 
draws for assessment of immunogenicity and drug concentrations. To ensure compliance and to 
monitor technique “office visit” SC injections should be conducted in the presence of a qualified 
investigational staff. 
4.3.1
Dose Modifications
4.3.1.1
Dose Modifications in the Absence of Adverse Events.
All Study Medications (Abatacept SC and matching placebo): Every effort should be made to 
give all medications within 3 days of the target date in the double-blind and open label 
treatment periods. The last dose before each office visit should be administered at least 4 days 
before the scheduled visit date. If study medication is not received within the dosing window, 
this dose should be skipped and the next dose must then be administered on the next scheduled 
target administration day.
In the long term extension period, the office visits may be modified to be 7 days of the target 
dosing administration day for a significant reason (including an adverse event).
During the double-blind period, any subject who misses greater than four consecutive doses
should be discontinued from the study.
During the open-label period, any subject who misses greater than six consecutive doses should 
be discontinued from the study.
4.3.1.2
Dose Modifications Due to Adverse Events
If abnormal laboratory test results or clinical adverse events indicate toxicity that, in the 
judgment of the investigator, could place the subject at risk, study drug administration should be 
interrupted and the investigator should notify the BMS medical monitor. Subjects may receive 
further study medication treatment only if full resolution of the adverse event or abnormal 
laboratory finding is documented.
If a dose is skipped, the next SC injection should be administered on the subsequent targeted 
administration day.
4.4
Blinding/Unblinding
Blinding of treatment assignment is critical to the integrity of this clinical study. However, in the 
event of a medical emergency or pregnancy in an individual subject in which knowledge of the 
Revised Protocol No.: 03
Date: 19-Aug-2014
41


Clinical Protocol
IM101332
BMS-188667
Abatacept
investigational product is critical to the subject's management, the blind for that subject may be 
broken by the investigator. The subject’s safety takes priority over any other considerations in 
determining if a treatment assignment should be unblinded.
Before breaking the blind of an individual subject's treatment, the investigator should determine 
that the unblinded information is necessary, ie, that it will alter the subject's immediate 
management. In many cases, particularly when the emergency is clearly not related to the 
investigational product, the problem may be properly managed by assuming that the subject is 
receiving active product. It is highly desirable that the decision to unblind treatment assignment 
be discussed with the Medical Monitor, but the investigator always has ultimate authority for the 
decision to unblind. The Principal Investigator should only call in for emergency unblinding 
AFTER the decision to discontinue the subject has been made.
For this study, the method of unblinding for emergency purposes is the IVRS. For information 
on how to unblind in an emergency, consult the IVRS material.
In cases of accidental unblinding, contact the Medical Monitor and ensure every attempt is made 
to preserve the blind.
Any request to unblind a subject for non-emergency purposes should be discussed with the 
Medical Monitor.
The BMS Bioanalytical Science Department or its designee will be unblinded to the randomized 
treatment assignments in order to minimize unnecessary analysis of PK and immunogenicity 
samples from the placebo group of subjects. Other members will remain blinded.
4.5
Treatment Compliance
Monthly study drug administration compliance will be performed at the investigational site 
office by reviewing the diary cards.
4.6
Destruction and Return of Study Drug
4.6.1
Destruction of Study Drug
For this study, study drugs (those supplied by BMS or sourced by the investigator) such as 
partially used study drug containers, vials and syringes may be destroyed on site. 
Any unused study drugs can only be destroyed after being inspected and reconciled by the 
responsible BMS Study Monitor unless study drug containers must be immediately destroyed as 
required for safety, or to meet local regulations (eg, cytotoxics or biologics). 
On-site destruction is allowed provided the following minimal standards are met:

On-site disposal practices must not expose humans to risks from the drug.

On-site disposal practices and procedures are in agreement with applicable laws and 
regulations, including any special requirements for controlled or hazardous substances.

Written procedures for on-site disposal are available and followed. The procedures must be 
filed with the site’s SOPs and a copy provided to BMS upon request.
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Clinical Protocol
IM101332
BMS-188667
Abatacept

Records are maintained that allow for traceability of each container, including the date 
disposed of, quantity disposed, and identification of the person disposing the containers. The 
method of disposal, ie, incinerator, licensed sanitary landfill, or licensed waste disposal 
vendor must be documented. 

Accountability and disposal records are complete, up-to-date, and available for the Monitor 
to review throughout the clinical trial period.
If conditions for destruction cannot be met the responsible BMS Study Monitor will make 
arrangements for return of study drug.
It is the investigator’s responsibility to arrange for disposal of all empty containers, provided that 
procedures for proper disposal have been established according to applicable federal, state, local, 
and institutional guidelines and procedures, and provided that appropriate records of disposal are 
kept.
4.6.2
Return of Study Drug
If study drug will not be destroyed upon completion or termination of the study, all unused 
and/or partially used study drug that was supplied by BMS must be returned to BMS. The return 
of study drug will be arranged by the responsible BMS Study Monitor. 
It is the investigator’s responsibility to arrange for disposal of all empty containers, provided that 
procedures for proper disposal have been established according to applicable federal, state, local, 
and institutional guidelines and procedures, and provided that appropriate records of disposal are 
kept. 
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Clinical Protocol
IM101332
BMS-188667
Abatacept
Table 5.1-1:
Screening Procedural Outline (IM101-332)
Procedure
Screening
Visit 1
Screening
Visit 2a
Notes
Laboratory Tests
TB Screening
X
TB screening should be performed during screening period & all 
testing be completed prior to randomization. 
Hepatitis B surface antigen (HbsAg)
X
If positive, obtain HBV DNA
Hepatitis B core antibody
X
If positive, obtain HBV DNA.
Hepatitis C antibody
X
If positive, obtain HCV RNA.
Hematology
X
X
CBC with platelets
Chemistry Panel
X
X
HIV Testing
X
HIV testing will performed in countries that require the testing.
Urinalysis
X
Urine/serum Pregnancy Test
X
X
WOCBP only
Rheumatoid Factor
X
Efficacy Assessments
Tender Joint Count (68)
X
X
Swollen Joint Count (66)
X
X
Identify and Assess Target Lesion 
X
X
% Body Surface Area of Psoriasis Involvement
X
X
ACR Functional Status Assessment
X
a An optional screening visit (Screening Visit 2) must be performed if >28 days has elapsed since Screening Visit 1 was performed. The Screening Visit 2 may 
be used if a subject qualified for the study but required additional time to stabilize on existing medication or additional time is required to receive all pertinent 
laboratory results.
Revised Protocol No.: 03
Date: 19-Aug-2014
45
4.0
Approved
930066785
4.0
v












Clinical Protocol
IM101332
BMS-188667
Abatacept
Table 5.1-3:
Flow Chart for Protocol IM101332 – Open Label Treatment Period
Procedure
OL-1
(Same day 
as final 
day in the 
Double 
Blind 
Period)
OL
-15
OL
-29
OL
-57
OL
-85
Day 
113 -
Phone 
Call
OL
-141
Day 169 
- Phone 
Call
OL
-197
Early 
Termination
Notes
Urine /serum pregnancy test
X
X
X
X
X
X
X
X
WOCBP only, results 
confirmed prior to 
administration of study 
drug, Pregnancy testing is 
required every 4 weeks.
The subject will be 
provided with urine 
pregnancy kits to be used at 
Day 113 and Day 169 at 
home.
Highly sensitive (hs) CRP
X
X
X
X
X
X
X
Efficacy Assessments
Tender Joint Count (68)
X
X
X
X
X
X
X
Swollen Join Count (66)
X
X
X
X
X
X
X
X-rays of hand and feet 
X
X
X
Only subjects who have 
entered the open label after 
early escape will have a 
Day 57 X-ray performed.
The allowed window for 
performance of the X-rays 
is ± 14 days.
Revised Protocol No.: 03
Date: 19-Aug-2014
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4.0
Approved
930066785
4.0
v


Clinical Protocol
IM101332
BMS-188667
Abatacept
Table 5.1-3:
Flow Chart for Protocol IM101332 – Open Label Treatment Period
Procedure
OL-1
(Same day 
as final 
day in the 
Double 
Blind 
Period)
OL
-15
OL
-29
OL
-57
OL
-85
Day 
113 -
Phone 
Call
OL
-141
Day 169 
- Phone 
Call
OL
-197
Early 
Termination
Notes
Subject’s Assessment of 
Physical Function (HAQ)
X
X
X
X
X
X
X
Revised Protocol No.: 03
Date: 19-Aug-2014
52
4.0
Approved
930066785
4.0
v






Clinical Protocol
IM101332
BMS-188667
Abatacept
Table 5.1-3:
Flow Chart for Protocol IM101332 – Open Label Treatment Period
Procedure
OL-1
(Same day 
as final 
day in the 
Double 
Blind 
Period)
OL
-15
OL
-29
OL
-57
OL
-85
Day 
113 -
Phone 
Call
OL
-141
Day 169 
- Phone 
Call
OL
-197
Early 
Termination
Notes
Dosing Injectable Study 
Medication
X
X
X
X
X1
X
X1
X
X2
Confirm the subject is 
giving the SC injections 
and recording the 
information on their diary 
cards.
1
One urine pregnancy 
kit and an 8 week supply of 
prefilled syringes will be 
dispensed to the subjects at 
this office visit along with 
two diary cards to capture 
injections.
2
If a subject continues 
into the long term 
extension, two pregnancy 
kits and a 12-week supply 
of pre-filled syringes will 
be dispensed to the subjects 
at this office visits along 
with a diary card to capture 
injections.
Revised Protocol No.: 03
Date: 19-Aug-2014
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4.0
Approved
930066785
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v




Clinical Protocol
IM101332
BMS-188667
Abatacept
Table 5.1-4:
Flow Chart for Protocol IM101332 – Long Term Extension 
Procedure
Phone 
Call
OL-225
Phone 
Call
OL-253
OL-
281
(± 7 
days)
Phone 
Call
OL-309
Phone 
Call
OL-337
OL-
365
(± 7 
days)
Phone 
Call
OL-393
Phone 
Call
OL-421
OL-
449
(± 7 
days)
Phone 
Call
OL-477
Phone 
Call
OL-505
Phone 
Call
OL-533
OL-
561
(± 7 
days)
Early 
Terminat
ion
Notes
Dosing 
Injectable 
Study Med
X
X
X1
X
X
X1
X
X
X1
X
X
X
X
Confirm the 
subject is 
administerin
g the SC 
injections 
weekly and 
recording the 
information 
on the diary 
cards.
1-A 12-week 
supply of 
pre-filled 
syringes will 
be dispensed 
to the 
subjects at 
the first three 
quarterly 
office visits 
along with a 
diary card to 
capture 
injection 
date, time 
and location 
and results 
of pregnancy 
testing for 
WCBP 
subjects. At 
the 
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Table 5.1-4:
Flow Chart for Protocol IM101332 – Long Term Extension 
Procedure
Phone 
Call
OL-225
Phone 
Call
OL-253
OL-
281
(± 7 
days)
Phone 
Call
OL-309
Phone 
Call
OL-337
OL-
365
(± 7 
days)
Phone 
Call
OL-393
Phone 
Call
OL-421
OL-
449
(± 7 
days)
Phone 
Call
OL-477
Phone 
Call
OL-505
Phone 
Call
OL-533
OL-
561
(± 7 
days)
Early 
Terminat
ion
Notes
beginning of 
the fourth 
quarter of 
the year, a 
16-week 
supply of 
prefilled 
syringes will 
be dispensed 
to the 
subject.
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Subjects who terminate early from the double blind treatment period, the open label period or the 
long term extension should complete the appropriate Early Termination Visit and the Post Drug 
Follow-up Visits. The Early Termination Visit should be as soon as possible after the last dose of 
study medication.
All assessments should be performed or administered prior to study drug administration unless 
otherwise indicated.
Only data for the procedures and assessments specified in this protocol should be submitted to 
BMS on a case report form. Additional procedures and assessments may be performed as part of 
standard of care; however, data for these assessments should remain in the subject’s medical 
record and should not be provided to BMS, unless specifically requested from BMS.
5.3.1
Imaging Assessment for the Study
Any incidental findings of potential clinical relevance that are not directly associated with the 
objectives of the protocol should be evaluated and handling by the Study Investigator as per 
standard medical/clinical judgment.
Plain radiographs of the hands and feet will be taken at baseline (Day 1, -3 days), Day 169 
(14 days) [and Day 113 (+14 days) and Open Label Day 57 (14 days) for subjects who 
qualify for the Early Escape], and Day 365 (Open Label 197) (14 days). Subjects who 
terminate the study early in the double-blind period or open label period will have radiographs 
taken at the Early Termination visit.
Radiographs of the hands and feet may be taken after dosing on Day 1 as long as they are 
performed on Day 1.
Radiography of the hands and feet will be standardized to ensure sufficient image quality for the 
evaluation of radiographic progression. Radiology facilities and personnel will be qualified for 
participation in the study based on the technical capabilities of the equipment and experience and 
the licensing of the x-ray technologists. Radiographic technique will be harmonized through the 
use of written radiographic procedure manual and training of x-ray technologists. In addition the 
film-screen system will be standardized to ensure sufficient resolution for the evaluation of 
erosions and joint space narrowing.
Radiographs collected for the study will be sent to a central reading facility for quality control 
and central evaluation (in a blinded manner) by a radiologist trained and experienced in the 
scoring of PsA by the Sharp-van der Heijde Modified Scoring Method (SHS) for psoriatic 
arthritis.41,42
Details of the standardization and evaluation of the radiographs will be covered in a separate 
Charter for the independent review of radiographs.
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5.3.2
Physical Examination
Complete and/or targeted (brief) physical examinations may be performed by a Doctor of 
Medicine (MD), Doctor of Osteopathy (DO), Physician’s Assistant (PA), or Nurse Practitioner 
(NP). 
While the brief interim physical exam may not be as comprehensive as the initial full 
examination, key aspects of the brief interim examination should evaluate important body 
systems as clinically indicated. The brief physical examination should include examination of the 
heart, lungs and abdomen, and may include other relevant body systems such as the lymph 
nodes, liver, spleen and breasts, at the discretion of the examiner. A brief interim physical 
examination may note any changes in the subject’s condition (body systems) since the last 
assessment and does not preclude examination of any of the body systems as clinically indicated.
5.3.3
Chest X-ray
A posterior-anterior and lateral chest x-ray, performed during screening, is required for all 
subjects unless performed within 6 months prior to obtaining written informed consent and 
documentation of the earlier x-ray is on file. All subjects must have a chest x-ray that does not 
show any cardiac or pulmonary disease in order to be eligible for this study. The chest x-ray 
result will be recorded on the appropriate page of the eCRF.
5.3.4
Physical Measurements
Weight and height is to be recorded at screening. Weight is to be recorded at the beginning and 
end of the double-blind and open label periods.
5.3.5
Vital Signs
Vital signs (seated blood pressure, heart rate, and temperature) will be recorded during the 
screening visit, during every visit, and at study discharge or as soon as possible after the last dose 
for subjects who terminate early, and at the post study drug follow-up visits. Blood pressure and 
heart rate should be measured after the subject has been seated quietly for at least 5 minutes.
5.3.6
TB Screening
A chest x-ray and physical examination are considered part of the process to assess a subject’s 
eligibility. In addition to a chest x-ray that does not show any cardiac or pulmonary disease and 
no suspicion of latent TB, a tuberculin skin test will be performed and interpreted according to 
local country Health Authorities and/or Medical Society guidelines. Some guidelines have 
specific recommendations for subjects who are to receive biologics or immunosuppressant 
therapies (eg, RA experience with biologic agents),43,44,45 or who are immunocompromised and 
who have had prior BCG vaccination(s).46,47 Tuberculin skin testing is not contraindicated for 
persons who have been vaccinated with BCG. An interferon gamma release assay (e.g., 
QuantiFERONGold or Tspot/ELISpot) is an acceptable alternative when skin testing for 
tuberculosis (i.e., PPD) is not appropriate.
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5.3.7
Laboratory Assessments
All laboratory assessments will be analyzed centrally with exception of the pregnancy testing.
Blood and/or urine samples will be obtained at all visits noted in Table 5.1-1, Table 5.1-2, Table 
5.1-3, Table 5.1-4, Table 5.1-5, Table 5.1-6, and Table 5.1-7 from each subject entered in this 
study. Any laboratory test result that the investigator considers clinically relevant should be 
recorded on the appropriate Adverse Event page of the CRF (see Appendix 5)
5.3.7.1
Hematology

Hemoglobin

Hematocrit

Total WBC count, including differential

Platelet count
5.3.7.2
Blood Chemistry

Sodium 
Creatinine

Potassium 
Blood urea nitrogen (BUN)

Chloride 
Total bilirubin

Total Protein 
Alanine aminotransferase (ALT)

Albumin 
Aspartate aminotransferase (AST)

Calcium 
Gamma-glutamyltransferase (GGT)

Phosphorus 
Alkaline phosphatase

Glucose
5.3.7.3
Fasting Lipid Panel
Total cholesterol
LDL cholesterol
HDL cholesterol
VLDL cholterol
Triglyceride
NOTE: A subject should be fasting at least 8 hours.
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5.3.7.4
Urinalysis (screening visit only)

pH

Protein

Glucose

Blood
Microscopic examination of the urine sediment is required if blood, protein or glucose is positive 
on the dipstick.
5.3.7.5
Hepatitis Screen (performed at Screening Visit Only)
The Laboratory result must be available prior to dosing.

Hepatitis B surface antigen, hepatitis B core antibody -- If positive reflex HBV DNA testing 
must be performed.

Hepatitis C antibody. If positive, reflex HCV RNA testing must be performed
5.3.7.6
Pregnancy Tests
Urine/serum pregnancy tests (minimum sensitivity 25 IU/L of -HCG) must be performed for all 
WOCBP within 24 hours prior to dosing for visits specified in Tables Table 5.1-1, Table 5.1-2
and Table 5.1-3. If any female subject becomes pregnant, she will be discharged from the study. 
A pregnancy surveillance form will be completed and submitted to Bristol-Myers Squibb. Serum 
pregnancy tests will be processed locally.
5.3.7.7
HIV Testing
HIV testing will be performed in countries where the testing is required in screening.
5.4
Efficacy Assessments
Only data for the procedures and assessments specified in this protocol should be submitted to 
BMS on a case report form. Additional procedures and assessments may be performed as part of 
standard of care; however, data for these assessments should remain in the subject’s medical 
record and should not be provided to BMS, unless specifically requested from BMS.
5.4.1
Primary Efficacy Assessment
The primary efficacy assessment will be the proportion of subjects meeting the ACR criteria for 
improvement (ACR20) at Day 169.
5.4.2
Secondary Efficacy Assessments
Key Secondary efficacy assessments comprise:

HAQ responders at Day 169
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5.4.5
Composite Scores
5.4.5.1
American College of Rheumatology Improvement Criteria (ACR20, 
ACR50, ACR70)
The ACR20, ACR50 or ACR70 definition of improvement is a 20%, 50% or 70% improvement, 
respectively, over baseline in tender and swollen joint counts (components #1 and #2) and a 
20%, 50% or 70% improvement, respectively, in 3 of the 5 remaining core data set measures 
(components #3 to #7) (Appendix 15). 52
5.4.5.2
Disease Activity Score 28 C-Reactive Protein (DAS28-CRP)
A composite measure that incorporates the number of tender and swollen joint (28 joint count), 
subject’s global assessment of disease activity on a visual analog scale, and the C-reactive 
protein (CRP).53 (Appendix 16)
DAS 28 = 0.56*sqrt(tender28) + 0.28*sqrt(swollen28) + 0.36*ln(CRP+1) + 0.014*GH + 
0.9654,55,56
5.4.5.3
Psoriatic Arthritis Disease Activity Score (PASDAS)
A composite measure calculated from the Physician Global Assessment of Psoriasis and Arthritis 
Disease Activity Visual Analog Scale, the Subject Global Assessment of Psoriasis and Arthritis 
Disease Activity Visual Analog Scale, the SF36 PCS, the swollen joint count, the tender joint 
count, the Leeds Enthesitis Index (ESI), the Leeds Dactylitis Index (LDI, Basic), and the 
hsCRP.57
5.4.5.4
Composite Psoriatic Disease Activity Index - Modified (CPDAI) 
The Modified CPDAI is a composite index that assesses four (4) domains: peripheral joints, skin, 
enthesitis, and dactylitis. Each category will be graded as mild, moderate, or severe (0-3), giving 
an overall attainable score of 0-15. Peripheral joints will be assessed by tender (68) and swollen 
(66) joint count; skin by the PASI and Dermatology Life Quality Index (DLQI); enthesitis by the 
number of involved digits on the Leeds Enthesitis Index (LEI) [the Health Assessment 
Questionnaire (HAQ) is counted if enthesitis is present]; dactylitis by the number of involved 
digits on the Leeds Dactylitis Index- Basic (LDI - Basic) (the HAQ is counted if dactylitis is 
present);.58,59,60
5.4.5.5
Minimal Disease Activity
A subject with PsA is classified as achieving MDA 60,61 when meeting 5 of the 7 following 
criteria: 

tender joint count 1

swollen joint count 1

PASI 1 or BSA 3%

subject pain VAS 15
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finding), symptom, or disease temporally associated with the use of investigational product, 
whether or not considered related to the investigational product.
The causal relationship to study drug is determined by a physician and should be used to assess 
all adverse events (AE). The casual relationship can be one of the following:

Related: There is a reasonable causal relationship between study drug administration and the 
AE.

Not related: There is not a reasonable causal relationship between study drug administration 
and the AE.
The term “reasonable causal relationship” means there is evidence to suggest a causal 
relationship. 
Adverse events can be spontaneously reported or elicited during open-ended questioning, 
examination, or evaluation of a subject. (In order to prevent reporting bias, subjects should not be 
questioned regarding the specific occurrence of one or more AEs.)
6.1
Serious Adverse Events
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: 

results in death

is life-threatening (defined as an event in which the subject was at risk of death at the time of 
the event; it does not refer to an event which hypothetically might have caused death if it 
were more severe)

requires inpatient hospitalization or causes prolongation of existing hospitalization 
(see NOTE below)

results in persistent or significant disability/incapacity

is a congenital anomaly/birth defect 

is an important medical event (defined as a medical event(s) that may not be immediately 
life-threatening or result in death or hospitalization but, based upon appropriate medical and 
scientific judgment, may jeopardize the subject or may require intervention [eg, medical, 
surgical] to prevent one of the other serious outcomes listed in the definition above.) 
Examples of such events include, but are not limited to, intensive treatment in an emergency 
room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not 
result in hospitalization.) Potential drug induced liver injury (DILI) is also considered an 
important medical event. (See Section 6.6 for the definition of potential DILI.)
Suspected transmission of an infectious agent (eg, pathogenic or nonpathogenic) via the study 
drug is an SAE.
Although pregnancy, overdose, cancer, and potential drug induced liver injury (DILI) are not 
always serious by regulatory definition, these events must be handled as SAEs.
(See Section 6.1.1 for reporting pregnancies).
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Any component of a study endpoint that is considered related to study therapy (eg, death is an 
endpoint, if death occurred due to anaphylaxis, anaphylaxis must be reported) should be reported 
as SAE (see Section 6.1.1 for reporting details.
NOTE: 
The following hospitalizations are not considered SAEs in BMS clinical studies: 

a visit to the emergency room or other hospital department < 24 hours, that does not 
result in admission (unless considered an important medical or life-threatening event)

elective surgery, planned prior to signing consent

admissions as per protocol for a planned medical/surgical procedure

routine health assessment requiring admission for baseline/trending of health status 
(eg, routine colonoscopy)

medical/surgical admission other than to remedy ill health and planned prior to entry into 
the study. Appropriate documentation is required in these cases

admission encountered for another life circumstance that carries no bearing on health 
status and requires no medical/surgical intervention (eg, lack of housing, economic 
inadequacy, caregiver respite, family circumstances, administrative reason).
6.1.1
Serious Adverse Event Collection and Reporting
Following the subject’s written consent to participate in the study, all SAEs, whether related or 
not related to study drug, must be collected, including those thought to be associated with 
protocol-specified procedures. All SAEs must be collected that occur during the screening period 
and within 6 months of discontinuation of dosing. If applicable, SAEs must be collected that 
relate to any later protocol-specified procedure (eg, a follow-up skin biopsy). 
The investigator should report any SAE that occurs after these time periods and that is believed 
to be related to study drug or protocol-specified procedure. 
An SAE report should be completed for any event where doubt exists regarding its seriousness. 
If the investigator believes that an SAE is not related to study drug, but is potentially related to 
the conditions of the study (such as withdrawal of previous therapy or a complication of a study 
procedure), the relationship should be specified in the narrative section of the SAE Report Form.
SAEs, whether related or not related to study drug, and pregnancies must be reported to BMS 
(or designee) within 24 hours. SAEs must be recorded on the SAE Report Form; pregnancies on 
a Pregnancy Surveillance Form (electronic or paper forms). When using paper forms, the reports 
are to be transmitted via email or confirmed facsimile (fax) transmission to:
For studies capturing SAEs/pregnancies through electronic data capture (EDC), electronic 
submission is the required method for reporting. The paper forms should be used and submitted 
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immediately, only in the event the electronic system is unavailable for transmission. When paper 
forms are used, the original paper forms are to remain on site.
 
If only limited information is initially available, follow-up reports are required. (Note: Follow-up 
SAE reports should include the same investigator term(s) initially reported.) 
If an ongoing SAE changes in its intensity or relationship to study drug or if new information 
becomes available, a follow-up SAE report should be sent within 24 hours to the BMS 
(or designee) using the same procedure used for transmitting the initial SAE report.
All SAEs should be followed to resolution or stabilization.
6.2
Nonserious Adverse Events
A nonserious adverse event is an AE not classified as serious.
6.2.1
Nonserious Adverse Event Collection and Reporting
The collection of nonserious AE information should begin at initiation of study drug. Nonserious 
AE information should also be collected from the start of a placebo lead-in period or other 
observational period intended to establish a baseline status for the subjects.
Nonserious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see Section 6.1.1) Follow-up is also required for nonserious AEs that cause 
interruption or discontinuation of study drug and for those present at the end of study treatment 
as appropriate. All identified nonserious AEs must be recorded and described on the nonserious 
AE page of the CRF (paper or electronic). 
Completion of supplemental CRFs may be requested for AEs and/or laboratory abnormalities 
that are reported/identified during the course of the study.
6.2.2
Nonserious Adverse Events Related to Study Condition
All SAEs of psoriatic arthritis or plaque psoriasis exacerbation must be reported according to 
SAE guidelines in Section 6.1.
Do not report non-serious adverse events of psoriatic arthritis or plaque psoriasis exacerbation as 
a non-serious adverse event.
6.3
Laboratory Test Result Abnormalities
The following laboratory test result abnormalities should be captured on the nonserious AE CRF 
page or SAE Report Form (paper or electronic) as appropriate:

Any laboratory test result that is clinically significant or meets the definition of an SAE 

Any laboratory test result abnormality that required the subject to have study drug 
discontinued or interrupted
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
Any laboratory test result abnormality that required the subject to receive specific corrective 
therapy.
It is expected that wherever possible, the clinical rather than laboratory term would be used by 
the reporting investigator (eg, anemia versus low hemoglobin value).
6.4
Pregnancy
If, following initiation of the investigational product, it is discovered that a study subject is 
pregnant or may have been pregnant at the time of investigational product exposure, including 
during at least 6 half lives after product administration, the investigational product will be 
permanently discontinued in an appropriate manner (eg, dose tapering if necessary for subject 
safety).
The investigator must immediately notify the BMS (or designee) Medical Monitor of this event 
and complete and forward a Pregnancy Surveillance Form to BMS (or designee) within 24 hours 
and in accordance with SAE reporting procedures described in Section 6.1.1. 
Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome and, where applicable, offspring information, must be reported on the Pregnancy 
Surveillance Form.
Any pregnancy that occurs in a female partner of a male study participant should be reported to 
BMS. Information on this pregnancy will be collected on the Pregnancy Surveillance Form.
6.5
Overdose
An overdose is defined as the accidental or intentional ingestion of any dose of a product that is 
considered both excessive and medically important.
All occurrences of overdose must be reported as SAEs (see Section 6.1.1 for reporting details).
6.6
Potential Drug Induced Liver Injury (DILI)
Specific criteria for identifying potential DILI have not been identified for this protocol. 
Standard medical practice in identifying and monitoring hepatic issues should be followed.
6.7
Other Safety Considerations
Any 
significant 
worsening 
noted 
during 
interim 
or 
final 
physical 
examinations, 
electrocardiogram, x-ray filming, any other potential safety assessment required or not required 
by protocol should also be recorded as a nonserious or serious AE, as appropriate, and reported 
accordingly. 
7
DATA MONITORING COMMITTEE AND OTHER EXTERNAL 
COMMITTEES
Not Applicable
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8
STATISTICAL CONSIDERATIONS
 
 
 
 
 
 
 
 
 
 
 
.
 
 
 
 
 
 
 
 
 
 
 
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8.4.2
Efficacy Analyses
All efficacy analyses will be for the intent-to-treat (ITT) analysis population, except if stated 
otherwise. In general, no formal statistical testing will take place except for the primary, the key 
secondary efficacy endpoints (including the ACR20 responders in the two TNFi subgroups) and 
the proportion of subjects achieving PASI50 at Day 169.
8.4.2.1
ACR20
Primary analysis at Day 169
The primary efficacy analysis regarding the comparison between abatacept and placebo in the 
proportion of ACR20 responders at Day 169
will be performed with a 2-sided 
Cochran-Mantel-Haenszel (CMH) Chi-square test, stratified by prior TNFi use (Yes, No), MTX 
use (Yes, No) and BSA (< 3%, 3%) at a 5% significance level. The Chi square p-value and the 
relative risk along with its 95% confidence interval will be provided at Day 169. In addition, the 
absolute treatment difference will be provided along with its 95% two-sided confidence interval 
based on the stratum-specific sample size weighting method 73 at all timepoints up to Day 169. 
All subjects who prematurely discontinue the study after receiving study medication will have 
missing data imputed as ACR20 non-responder at all scheduled protocol visits subsequent to the 
point of discontinuation. Rescue medication and early escape after Day 113 as described in 
sections 3.1.2 and 3.1.3 will be allowed. After receiving this rescue medication, the as-observed 
ACR20 response will be used in the ACR20 analysis up to Day 169; however, for subjects 
switching to open label abatacept in the early escape period, the subjects will be imputed as 
non-responders for the ACR20 responder analyses up to Day 169. The primary analysis will be 
done for the intent-to-treat (ITT) analysis population.
Sensitivity Analysis at Day 169
The following sensitivity analyses for the primary analysis of ACR20 response at Day 169 will 
be performed:

analysis applying the per-protocol analysis population.

To investigate if imbalances in demography characteristics and/or baseline characteristics do 
not have an impact on the primary result, a logistic regression including treatment, prior 
TNFi use, MTX use, BSA, demographic variables (age, gender, and weight) and baseline 
variables (duration of disease, tender joints, swollen joint, HAQ DI, pain, subject global 
assessment of disease activity, physician global assessment of disease activity, CRP and 
current oral corticosteroid use) will be performed. 
Subgroup Analysis by TNFi use
The efficacy analysis regarding the comparison between abatacept and placebo in the proportion 
of ACR20 responders at Day 169 in the prior TNFi users subgroup and in the TNFi naive 
subgroup separately will be with a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test, 
stratified by MTX use and BSA at a 5% significance level. The Chi-square p-value and the 
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relative risk along with its 95% confidence interval will be provided for both subgroups at 
24 weeks. In addition, the absolute treatment difference will be provided along with its 95% 
two-sided confidence interval based on the stratum-specific sample size weighting method73 for 
both subgroups at 24 weeks. The handling of missing data, rescue medication, and early escape
will be performed in same way as done for ACR20 responders for the full population.
 
 
 
 
 
8.4.2.2
HAQ 
Primary analysis of HAQ responders at Day 169
The efficacy analysis regarding the comparison between abatacept and placebo in the proportion 
of HAQ responders at Day 169 will be performed with a 2-sided Cochran-Mantel-Haenszel 
(CMH) Chi-square test, stratified by prior TNFi use, MTX use and BSA at a 5% significance 
level. The Chi-square p-value and the relative risk along with its 95% confidence interval will be 
provided at Day 169. In addition, the absolute treatment difference will be provided along with 
its 95% two-sided confidence interval based on the stratum-specific sample weighting method 73
at all timepoints up to 24 weeks. The handling of missing data, rescue medication and early 
escape will be performed in same way as done for ACR20 responders.
 
 
 
 
 
 
 
 
 
 
 
 
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8.4.2.3
PsA-Modified Total Sharp/van der Heijde Score (SHS)
Primary analysis of non-progressors using total PsA-modified total Sharp/van der Heijde score 
(SHS)
The efficacy analysis regarding the comparison between abatacept and placebo in the proportion 
of non-progressors using total PsA-modified total Sharp/van der Heijde score (SHS) at Day 169 
will be performed with a 2-sided Cochran-Mantel-Haenszel (CMH) Chi-square test, stratified by 
prior anti-TNF use, MTX use and BSA at a 5% significance level. The Chi square p-value and 
the relative risk along with its 95% confidence interval will be provided at Day 169. In addition, 
the absolute treatment difference will be provided along with its 95% two-sided confidence 
interval based on the stratum-specific sample weighting method at Day 169.
All subjects who prematurely discontinue the study after receiving study medication and prior to 
Day 169 window (± 8 weeks from the scheduled Day 169 visit) will have missing data imputed 
as progressors at Day 169. Rescue medication and early escape on Day 113 as described in 
sections 3.1.2 and 3.1.3 will be allowed. After receiving this rescue medication the as-observed 
x-ray data will be used in the x-ray analyses at Day 169, however, for subjects switching to open 
label abatacept in the early escape period, the subjects will be imputed as progressor at Day 169.
Sensitivity analyses at Day 169
The following sensitivity analyses are planned: 

The non-progressor analysis at Day 169 will be repeated, but the observed data at Day 169 
after switching to open label abatacept in the early escape period will be used instead of 
treating these subjects as progressors.

The non-progressor analysis at Day 169 will be repeated, but a non-progressor will be 
defined as a change from baseline in total PsA-modified SHS SDC (smallest detectable 
change).

The non-progressor analysis at Day 169 will be repeated, but a non-progressor will be 
defined as a change from baseline in total PsA modified SHS 0.5.
 
 
 
 
 
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8.4.2.4
PASI50
Primary analysis at Day 169
The efficacy analysis regarding the comparison between abatacept and placebo in the proportion 
of subjects achieving a PASI50 (achieving at least 50% improvement from baseline in PASI) at 
Day 169
in subjects with baseline BSA 3% will be performed with a 2-sided 
Cochran-Mantel-Haenszel (CMH) Chi-square test, stratified by prior TNFi use, and MTX use at 
a 5% significance level. The Chi square p-value and the relative risk along with its 95% 
confidence interval will be provided at Day 169. In addition, the absolute treatment difference 
will be provided along with its 95% two-sided confidence interval based on the stratum-specific 
sample weighting method73 at Day 169. The handling of missing data, rescue medication and 
escape will be performed in same way as done for ACR20 responders.
 
 
 
 
 
 
8.4.2.5
ACR50 and ACR70
The proportion of subjects with an ACR50, and ACR70 response at the different timepoints up to 
Day 169 will be summarized per treatment group using point estimates and 95% confidence 
intervals. Differences in ACR50, and in ACR70 response rates at the different timepoints will be 
summarized using point estimates and 95% confidence intervals based on the stratum-specific 
sample weighting method.73 A stratification by prior TNFi use, MTX use and BSA will be 
applied.
 
 
The handling of missing data, rescue medication, and escape will be performed in same way as 
done for ACR20 responders. All these analyses will be done for the intent-to-treat (ITT) analysis 
population (all subjects randomized and treated in the study will be included in the analyses).
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
BMS

Regulatory Authority(ies), if required by local regulations
Documentation of approval signed by the chairperson or designee of the IRB(s)/IEC(s) must be 
sent to BMS.
If an amendment substantially alters the study design or increases the potential risk to the 
subject: (1) the consent form must be revised and submitted to the IRB(s)/IEC(s) for review and 
approval/favorable opinion; (2) the revised form must be used to obtain consent from subjects 
currently enrolled in the study if they are affected by the amendment; and (3) the new form must 
be used to obtain consent from new subjects prior to enrollment.
If the revision is an administrative letter, investigators must inform their IRB(s)/IEC(s).
9.1.2
Monitoring
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site they will review study records and directly compare 
them with source documents, discuss the conduct of the study with the investigator, and verify 
that the facilities remain acceptable. Certain CRF pages and/or electronic files may serve as the 
source documents:
In addition, the study may be evaluated by BMS internal auditors and government inspectors 
who must be allowed access to CRFs, source documents, other study files, and study facilities. 
BMS audit reports will be kept confidential.
The investigator must notify BMS promptly of any inspections scheduled by regulatory 
authorities, and promptly forward copies of inspection reports to BMS. 
9.1.3
Investigational Site Training
Bristol-Myers Squibb will provide quality investigational staff training prior to study initiation. 
Training topics will include but are not limited to: GCP, AE reporting, study details and 
procedure, electronic CRFs, study documentation, informed consent, and enrollment of WOCBP.
9.2
Records
9.2.1
Records Retention
The investigator must retain all study records and source documents for the maximum period 
required by applicable regulations and guidelines, or institution procedures, or for the period 
specified by BMS, whichever is longer. The investigator must contact BMS prior to destroying 
any records associated with the study.
BMS will notify the investigator when the study records are no longer needed.
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If the investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed upon designee (eg, another investigator, IRB). Notice of such 
transfer will be given in writing to BMS.
9.2.2
Study Drug Records 
It is the responsibility of the investigator to ensure that a current disposition record of 
investigational product (those supplied by BMS) is maintained at each study site where study 
drug are inventoried and dispensed. Records or logs must comply with applicable regulations and 
guidelines and should include:

amount received and placed in storage area

amount currently in storage area

label identification number or batch number 

amount dispensed to and returned by each subject, including unique subject identifiers

amount transferred to another area/site for dispensing or storage

nonstudy disposition (eg, lost, wasted) 

amount destroyed at study site, if applicable

amount returned to BMS

retain samples for bioavailability/bioequivalence, if applicable 

dates and initials of person responsible for Investigational Product dispensing/accountability, 
as per the Delegation of Authority Form.
BMS will provide forms to facilitate inventory control if the investigational site does not have an 
established system that meets these requirements.
9.2.3
Case Report Forms
An investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation on each individual treated 
or entered as a control in the investigation. Data that are derived from source documents and 
reported on the CRF must be consistent with the source documents or the discrepancies must be 
explained. Additional clinical information may be collected and analyzed in an effort to enhance 
understanding of product safety. CRFs may be requested for AEs and/or laboratory abnormalities 
that are reported or identified during the course of the study.
For sites using the BMS electronic data capture tool, electronic CRFs will be prepared for all 
data collection fields except for fields specific to SAEs and pregnancy, which will be reported on 
the paper or electronic SAE form and Pregnancy Surveillance form, respectively. Spaces may be 
left blank only in those circumstances permitted by study-specific CRF completion guidelines 
provided by BMS. 
The confidentiality of records that could identify subjects must be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
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The investigator will maintain a signature sheet to document signatures and initials of all persons 
authorized to make entries and/or corrections on CRFs. 
The completed CRF, including any paper or electronic SAE/pregnancy CRFs, must be promptly 
reviewed, signed, and dated by the investigator or qualified physician who is a subinvestigator 
and who is delegated this task on the Delegation of Authority Form. For electronic CRFs, review 
and approval/signature is completed electronically through the BMS electronic data capture tool. 
The investigator must retain a copy of the CRFs including records of the changes and 
corrections.
Each individual electronically signing electronic CRFs must meet BMS training requirements 
and must only access the BMS electronic data capture tool using the unique user account 
provided by BMS. User accounts are not to be shared or reassigned to other individuals.
9.3
Clinical Study Report and Publications
A Signatory Investigator must be selected to sign the clinical study report. 
The data collected during this study are confidential and proprietary to BMS. Any publications 
or abstracts arising from this study require approval by BMS prior to publication or presentation 
and must adhere to BMS’s publication requirements as set forth in the approved clinical trial 
agreement (CTA). All draft publications, including abstracts or detailed summaries of any 
proposed presentations, must be submitted to BMS at the earliest practicable time for review, but 
at any event not less than 30 days before submission or presentation unless otherwise set forth in 
the CTA. BMS shall have the right to delete any confidential or proprietary information 
contained in any proposed presentation or abstract and may delay publication for up to 60 days 
for purposes of filing a patent application.
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10
GLOSSARY OF TERMS
Term
Definition
Adverse Reaction
An adverse event that is considered by either the investigator or 
BMS as related to the investigational product
Early Escape
At Week 16 (Day 113) any subject who has not achieved at 
least a 20% improvement in the tender joint count and the 
swollen joint count (both must improve) compared to baseline 
will be designated an “Early Escape” and will receive open-
label abatacept 125 mg SC. All Day 113 as well as early escape 
assessments will be performed at this time. 
Rescue Therapy
Per the investigator’s discretion, certain therapies are allowed 
to treat a flare of arthritis or psoriasis according the specified 
protocol once during the double-blind period and once during 
the open-label period.
Unexpected Adverse 
Reaction
An adverse reaction, the nature or severity of which is not 
consistent with the applicable product information 
(eg, Investigator Brochure for an unapproved investigational 
product)
Inadequate Response to 
Non-Biologic Therapy
Prior treatment with MTX, leflunomide, or sulfsalazine at a 
therapeutic dose for at least 3 months (For MTX, therapeutic 
dose is define as at least 15 mg weekly.), that was discontinued 
for lack of efficacy or was associated with ongoing active 
disease.
Intolerance to Non-Biologic 
Therapy
Discontinuation or dose limitation of MTX, sulfasalazine, or 
leflunomide due to an adverse event.
Inadequate Response to 
TNFi Therapy
Prior treatment with a TNFi at an approved dose for at least 
3 months, which was discontinued for lack of efficacy or was
associated with ongoing active disease.
Intolerance to TNFi Therapy
Discontinuation or dose limitation of a TNFi due to an adverse 
event.
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FUV
Follow-up Visit
GCP
Good Clinical Pratice
GGT
Gamma glutanyl transferase
HAQ
Health Assessment Questionnaire
HBV
Hepatitis B virus
HCG
Human chorionic gonadtropin
HCV
Hepatitis C virus
HDL
High density lipoprotein
HIV
Human Immunodeficiency Virus
HGB
Hemoglobin
HRT
Hormone Replacement Therapy
IA
Intra-articular
ICH
International Conference on Harmonisation
INH
Isoniazid
IRB/IEC
Institutional Review Board/Independent Ethics Committee
IM
Intramuscular
ITT
Intent to treat
IV
Intravenous
IVRS
Interactive Voice Response System
LDL
Low density lipoproteins
MCS
Mental Component Score
MD
Medical Doctor
MDA
Minimal Disease Activity
MMF
Mycophenolae Mofetil
MMP
Matrix metalloproteinases
MS
Multiple Sclerosis
MTX
Methotrexate
NP
Nurse Practitioner
NSAID
Non-Steroidal Anti-Inflammatory Drug
PA
Physician’s Assistant
PASDAS
Psoriatic Arthritis Disease Activity Score
PASI
Psoriasis Area and Severity Index
PCS
Physical Component Score
PD
Pharmacodynamic
PK
Pharmacokinetics
PP
Per protocol
PPK
Population pharmacokinetics
PPD
Purified protein derivative skin test
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PsA
Psoriatic arthritis
PUVA
Psoralen Plus Ultraviolet A
RA
Rheumatoid Arthritis
RNA
Ribonucleic Acid
SAE
Serious Adverse Event
SC
Subcutaneous
SDD
Smallest detectable difference
SF-36
Short Form 36
SHS
Sharp/van der Heidje Score
SLE
System Lupus Erythmatous
SNP
Single Nucleotide Polymorphisms
SJC
Swollen Joint Count
SOP
Standard operating procedure
TB
Tuberculosis
TL
Target Lesion
TLS
Target Lesion Score
TJC
Tender Joint Count
TNFi
Tumor necrosis factor-inhibitors
UVB
Ultraviolet B
VAS
Visual Analog Scale
VLDL
Very low density lipoproteins
WBC
White Blood Count
WHO
Wood Health Organization
WOCBP
Women of Child Bearing Potential
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APPENDIX 1
CLASSIFICATION CRITERIA FOR PSORIATIC ARTHRITIS 
(CASPAR) CRITERIA 
CASPAR CRITERIA (Specificity 0.987, Sensitivity 0.914)
Inflammatory articular disease (joint, spine or entheseal)
With 3 or more point from the following
1. Current psoriasis (scores 2 points) 
Psoriatic skin or scalp disease present today as judged 
by a rheumatologist
2. Personal history of psoriasis (if current psoriasis not 
present)
A history of psoriasis that may be obtained from 
patient, family doctor, dermatologist or rheumatologist
3. Family history of psoriasis (if personal history of 
psoriasis or current psoriasis not present)
A history of psoriasis in a first or second degree relative 
according to patient report
4. Psoriatic nail dystrophy
Typical psoriatic nail dystrophy including onycholysis, 
pitting and hyperkeratosis observed on current physical 
examination
5. A negative test for rheumatoid factor
By any method except latex but preferably by ELISA or 
nephlemetry, according to the local laboratory 
reference range
6. Current dactylitis
Swelling of an entire digit
7. History of dactylitis (if current dactylitis is not 
present)
A history of dactylitis recorded by a rheumatologist
8. Radiological evidence of juxta-articular new bone 
formation
Ill-defined ossification near joint margins (but 
excluding osteophyte formation) on plain xrays of hand 
or foot
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APPENDIX 2
GUIDANCE ON CONTRACEPTION
The investigator shall describe the length of time that strict precautions against pregnancy must 
be observed and provide guidance on the use of appropriate methods for sexually active subjects 
and their partners. Women and men who are not capable of reproduction or choose to be 
abstinent shall be exempt from following the pregnancy prevention requirements specified 
below.
DURATION OF MANDATORY CONTRACEPTION:
For Abatacept:  
Females:  WOCBP must use a highly effective method of contraception throughout the study and 
for 100 days after the last dose of study drug.
Males:  Because the concentration of abatacept in the semen is expected to be low, no 
contraception is required for males subjects taking the study drug.
For Teratogenic Concomitant Medications:
Males and females taking a teratogenic medication should follow contraception guidelines and 
duration described in the label for the concomitant medications in addition to those required for 
abatacept.
CONTRACEPTIVE METHODS:
A. Highly Effective Methods of Contraception
Highly effective methods of contraception have a failure rate of < 1% when used consistently 
and correctly.  WOCBP are expected to use one of the highly effective methods of contraception 
listed below:
1. Male condoms with spermicide
2. Hormonal methods of contraception including combined oral contraceptive pills, vaginal 
ring, injectables, implants and intrauterine devices (IUDs) such as Mirena
3. IUDs, such as ParaGard
4. Tubal ligation 
5. Vasectomy
For abatacept, WOCBP must use a highly effective method of contraception.
For teratogenic concomitant medications:  Males and females taking a teratogenic medication 
should follow contraception guidelines and duration described in the label for the concomitant 
medications in addition to those required for abatacept.
B. Abstinence

Abstinence is an acceptable form of contraception for all study drugs.

Subjects who choose abstinence must continue to have pregnancy tests, as specified in 
Section 5.3.7.6 of the body of the protocol. 
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Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the subject chooses to forego abstinence.
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APPENDIX 3
AMERICAN COLLEGE OF RHEUMATOLOGY 1991 REVISED
CRITERIA FOR THE CLASSIFICATION OF FUNCTIONAL 
STATUS IN RHEUMATOID ARTHRITIS
American College of Rheumatology 1991 Revised Criteria for the Classification of Functional Status in 
Rheumatoid Arthritis
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
*Usual self-care activities include dressing, feeding, bathing, grooming, and toileting.  Avocational (recreational 
and/or leisure) and vocational (work, school, homemaking) activities are subject-desired and age- and 
sex-specific.
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APPENDIX 5
LABORATORY GUIDELINES: PATIENT STUDIES (REVISED 
AUGUST 13, 1999)
Laboratory test results, which meet these criteria, and the Investigator feels is clinically relevant 
should be described on the Adverse Event Form. Those which are judged to be SERIOUS events 
require the completion of a Serious Adverse Event Form (see Sections 6.1.1 and 6.3).
[NOTE:  LLN = lower limit of normal; ULN = upper limit of normal.]
albumin - <0.9xLLN or if pretreatment value is <LLN, <0.75x pretreatment
alkaline phosphatase - >2 x ULN; or if pretreatment >ULN, 3x pretreatment value
basophils (%) - >3% if 0-1% pretreatment, >3x pretreatment value if pretreatment >1%
bilirubin
a.
direct - >1.5x ULN, or if pretreatment above ULN, >2x pretreatment
b.
total - >2x upper limit of normal, or if pretreatment above ULN, >4 x 
pretreatment value
blasts - >0
blood urea nitrogen (BUN) - >2x pretreatment
calcium - <0.8x LLN or >1.2x ULN; <0.75x pretreatment if pretreatment below LLN, or >1.25x 
pretreatment if pretreatment above ULN; >ULN if <LLN pretreatment, or <LLN if >ULN 
pretreatment
chloride - <0.9x LLN or >1.1x ULN; or <0.9x pretreatment if pretreatment below LLN, or >1.1x 
pretreatment if pretreatment above ULN; >ULN if <LLN pretreatment, or <LLN if >ULN 
pretreatment
creatinine - >1.5x pretreatment value
eosinophils (%) - >3x pretreatment and > 8% if pretreatment normal; if pretreatment >ULN, >3 
x pretreatment
erythrocytes - <0.75x pretreatment value
glucose - <0.8x LLN or >1.5x ULN; if pretreatment <LLN then <0.8x pretreatment; if 
pretreatment >ULN then >2x pretreatment; <LLN if >ULN pretreatment, or >ULN if <LLN 
pretreatment
hematocrit - <0.75x pretreatment
hemoglobin - >3 g/dL decrease from pretreatment value
lactic dehydrogenase (LDH) - >1.5x ULN; if pretreatment value is above ULN, >3x 
pretreatment value
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leukocyte (WBC) count - <0.75 x LLN or >1.25x ULN; <0.8x pretreatment if pretreatment 
<LLN or >1.2x pretreatment if pretreatment >ULN; >ULN if pretreatment <LLN or <LLN if 
>ULN pretreatment
lymphocytes (%) - <0.5x LLN or >2.0 x ULN, or <0.5x pretreatment if below LLN 
pretreatment; >2.0x pretreatment if above ULN pretreatment.  >ULN if <LLN pretreatment, or 
<LLN if >ULN pretreatment
monocytes (%) - >2x ULN; >2x pretreatment if pretreatment above ULN
neutrophil count (neutrophils+bands) - <0.67x pretreatment if pretreatment <1000/mm3; 
otherwise, <1000/mm3.
phosphate - <0.75 x LLN or >1.25x ULN; <0.67x pretreatment value if below LLN 
pretreatment, or >1.33x pretreatment if above ULN pretreatment; >ULN if <LLN pretreatment, 
or <LLN if >ULN pretreatment
platelet count - <0.67x LLN or >1.5 x ULN; if below normal pretreatment, <0.5x pretreatment 
value and <100,000/mm3
potassium - <0.9x LLN or >1.1x ULN; <0.9x pretreatment if pretreatment below LLN, or >1.1x 
pretreatment if pretreatment above ULN; >ULN if <LLN pretreatment, or <LLN if >ULN 
pretreatment
protein, total - <0.9x LLN or >1.1x ULN; <0.9 x pretreatment if below LLN pretreatment, or 
>1.1x ULN if above ULN pretreatment; >ULN if <LLN pretreatment, or <LLN if >ULN 
pretreatment
SGOT and SGPT (ASAT and ALAT) - >3 x upper limit of normal; if pretreatment above 
ULN, >4x pretreatment value
sodium - <0.95x LLN or >1.05x ULN; <0.95x pretreatment if below LLN pretreatment, >1.05x 
pretreatment if above ULN pretreatment; >ULN if <LLN pretreatment, or <LLN if >ULN 
pretreatment
uric acid - >1.5x ULN; if pretreatment above ULN, >2x pretreatment value
urinalysis
a) urinary protein - >1 gram/24 hours and 2x pretreatment value
b) urinary RBC - >5/HPF or, >4x pretreatment if pretreatment value 5/HPF
c) urinary WBC - >5/HPF or, >4x pretreatment if 5/HPF pretreatment
d) creatinine clearance (glomerular filtration rate) - <0.67x pretreatment value
e) urine dipstick measurements:  Protein, blood, sugar, and acetone- 2+, or if 
1+pretreatment, 2x pretreatment. Do not evaluate protein if quantitative protein 
determination done
stool hemoccult - positive if negative pretreatment
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