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 - Full Text View

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:

Genetics Home Reference related topics: psoriatic arthritis

U.S. FDA Resources

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:	150
Study Start Date:	December 2011
Estimated Study Completion Date:	December 2014
Estimated 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

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

Contacts

Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Show 65 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More 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:	August 21, 2012
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
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases

Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013