Phase IIB Psoriatic Arthritis Dose Ranging Study for BMS-945429 in subjects who are not responding to NSAIDs or non-biologic DMARD therapy

Conditions: Arthritis, Psoriatic
MedDRA version: 17.1Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-004016-29-DE

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 224

Inclusion Criteria

• Must be on a stable background methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose = 15 mg to a maximum weekly dose of = 25 mg, and be at a stable dose for 4 weeks prior to enrollment. Methotrexate dose = 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed.
• Inadequate response to NSAID or non-biologic DMARD
• Minimum of 3 swollen and 3 tender joints
• Active psoriatic skin lesions over minimum 3% body surface area
• hsCRP = 0.3 mg/dL
• Subjects must have diagnosis of active PsA by Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 12 weeks prior to screening

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 213
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

• Previously received or currently receiving concomitant biologic therapy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to NSAIDs and non-biologic DMARDs;Secondary Objective: 1) Proportion of subjects achieving PASI 75 response rate at Weeks 16 and 24<br>2) Proportion of subjects achieving ACR50 and ACR70 response rate at Weeks 16 and 24<br>3) Proportion of subjects achieving ACR20 response rate at Week 24<br>4) Proportion of subjects achieving a HAQ response at Weeks 16 and 24, as measured by a reduction of at least 0.3 unit from baseline in HAQ index<br>5) SF-36 changes from baseline to Weeks 16 and 24<br>6) AEs, vital signs, physical examinations, safety lab values, and immunogenicity during double-blind period;Primary end point(s): American College of Rheumatology criteria (ACR20);Timepoint(s) of evaluation of this end point: At 16 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Proportion of subjects achieving PASI 75 response rate <br>2) Proportion of subjects achieving ACR50 and ACR70 response rate<br>3) Proportion of subjects achieving ACR20 response rate<br>4) Mean change from baseline in Health Assessment Questionnaire (HAQ) Index<br>5) Proportion of subjects achieving a HAQ response, as measured by a reduction of at least 0.3 unit from baseline in HAQ index<br>6) SF-36 changes from baseline<br>7) AEs, vital signs, safety lab values, and immunogenicity during double-blind period;Timepoint(s) of evaluation of this end point: Week 16 and Week 24