A Phase 3 Randomized Placebo Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults with Active Psoriatic Arthritis

INTERVENTION:

Product Name: Abatacept Product Code: BMS‐188667 Pharmaceutical Form: Solution for injection INN or Proposed

INN:

ABATACEPT CAS Number: 332348‐12‐6 Current Sponsor code: BMS‐188667 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125‐ Pharmaceutical form of the placebo: Solution for injection in pre‐filled syringe Route of administration of the placebo: Subcutaneous use

CONDITION:

Active Psoriatic Arthritis ; MedDRA version: 16.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20]

PRIMARY OUTCOME:

Main Objective: To compare the efficacy of abatacept to placebo as assessed by the ACR20 response at Day 169. Primary end point(s): Proportion of ACR20 responders Secondary Objective: ? 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 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 of x‐rays [using the PsA modified Sharp/van der Heidje score (SHS)] from baseline to Day 169 Timepoint(s) of evaluation of this end point: Day 169

SECONDARY OUTCOME:

Secondary end point(s): 1) HAQ responders; 2) ACR20 responders (TNF‐naïve); 3) ACR20 responders (TNFi exposed); 4) Non‐progressors in total PsA modified SHS; 5) PASI50 responders; 6) ACR50 responders; 7) ACR70 responders; 8) Mean change in the SF36 subscales.; 9) Immunogenicity; 10) Safety Timepoint(s) of evaluation of this end point: 1) Day 169; 2) Day 169; 3) Day 169; 4) Day 169; 5) Day 169; 6) Day 169; 7) Day 169; 8) Day 169; 9) Day 1 to Day 169; 10) Day 1 to Day 169

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. ? Subjects must have had an inadequate response or intolerance to at least one non‐biologic disease‐modifying anti‐rheumatic drug (DMARD). ? Subjects may have been exposed to TNFi therapy. Subjects may have discontinued for any reason (inadequate response, intolerance or other). ? Subjects may enroll on certain concomitant non‐biologic DMARDs (methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) provided the medication has bee