Clinical Trial: Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging, Multi-Center Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection in Adults With Active 20% ACR response



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 75 response rate [ Time Frame: Week 16 and Week 24 ]
  • Proportion of subjects achieving ACR50 and ACR70 response rate [ Time Frame: Week 16 and Week 24 ]
    50% and 70 % ACR response
  • Proportion of subjects achieving ACR20 response rate [ Time Frame: Week 24 ]
  • Proportion of subjects achieving a Health Assessment Questionnaire (HAQ) response [ Time Frame: Weeks 16 and Week 24 ]
    As measured by a reduction of at least 0.3 unit from baseline in HAQ index
  • Short Form (36) [SF-36] changes from baseline [ Time Frame: Baseline (Day 1) and Week 16 ]
  • Short Form (36) [SF-36] changes from baseline [ Time Frame: Baseline (Day 1) and Week 24 ]
  • Safety and tolerability as measured by adverse events (AEs), vital signs, physical examinations and safety lab values [ Time Frame: 24 Weeks (during double-blind period) ]
  • Immunogenicity as measured by anti-BMS-945429 antibodies levels in serum [ Time Frame: 24 Weeks (during double-blind period) ]


Original Secondary Outcome:

  • Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 75 response rate [ Time Frame: Week 16 and Week 24 ]
  • Proportion of subjects achieving ACR50 and ACR70 response rate [ Time Frame: Week 16 and Week 24 ]
    50% and 70 % ACR response
  • Proportion of subjects achieving ACR20 response rate [ Time Frame: Week 24 ]
  • Proportion of subjects achieving a Health Assessment Questionnaire (HAQ) response [ Time Frame: Weeks 16 and Week 24 ]
    As measured by a reduction of at least 0.3 unit from baseline in HAQ index
  • Short Form (36) [SF-36] changes from baseline [ Time Frame: Baseline and Week 16 ]
  • Short Form (36) [SF-36] changes from baseline [ Time Frame: Baseline and Week 24 ]
  • Safety and tolerability as measured by adverse events (AEs), vital signs, physical examinations and safety lab values [ Time Frame: 24 Weeks (during double-blind period) ]
  • Immunogenicity as measured by anti-BMS-945429 antibodies levels in serum [ Time Frame: 24 Weeks (during double-blind period) ]


Information By: Alder Biopharmaceuticals, Inc.

Dates:
Date Received: November 14, 2011
Date Started: December 2011
Date Completion:
Last Updated: July 24, 2015
Last Verified: July 2015