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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01490450
First received: November 14, 2011
Last updated: November 20, 2014
Last verified: September 2014
  Purpose

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 Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).


Condition Intervention Phase
Arthritis, Psoriatic
Biological: Placebo matching BMS-945429
Biological: BMS-945429
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • American College of Rheumatology criteria (ACR20) [ Time Frame: At 16 weeks ] [ Designated as safety issue: No ]
    20% ACR response


Secondary Outcome Measures:
  • Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 75 response rate [ Time Frame: Week 16 and Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving ACR50 and ACR70 response rate [ Time Frame: Week 16 and Week 24 ] [ Designated as safety issue: No ]
    50% and 70 % ACR response

  • Proportion of subjects achieving ACR20 response rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving a Health Assessment Questionnaire (HAQ) response [ Time Frame: Weeks 16 and Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Short Form (36) [SF-36] changes from baseline [ Time Frame: Baseline (Day 1) and Week 24 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Immunogenicity as measured by anti-BMS-945429 antibodies levels in serum [ Time Frame: 24 Weeks (during double-blind period) ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: December 2011
Estimated Study Completion Date: January 2016
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PBO: Placebo matching BMS-945429 Biological: Placebo matching BMS-945429
Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Experimental: BMS-945429 (25mg) Biological: BMS-945429
Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Experimental: BMS-945429 (100mg) Biological: BMS-945429
Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Experimental: BMS-945429 (200mg) Biological: BMS-945429
Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). 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 and/or non-biologic DMARD
  • Minimum of 3 swollen and 3 tender joints
  • Active psoriatic skin lesions over minimum 3% body surface area
  • high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL

Exclusion Criteria:

  • Previously received or currently receiving concomitant biologic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490450

  Show 49 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01490450     History of Changes
Other Study ID Numbers: IM133-004, 2011-004016-29
Study First Received: November 14, 2011
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: State Institute for Drug Control
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Office for Radiation Protection
Germany: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: Federal Commission for Sanitary Risks Protection
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014