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 currently recruiting participants.
Verified August 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01490450
First received: November 14, 2011
Last updated: August 21, 2012
Last verified: August 2012
  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: 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

  Hide Study Locations
Locations
United States, California
San Diego Arthritis Medical Clinic Recruiting
San Diego, California, United States, 92104
Contact: Ara Dikranian, Site 013    619-287-9730      
United States, Colorado
Local Institution Not yet recruiting
Denver, Colorado, United States, 80230
Contact: , Site 008         
United States, Connecticut
New England Research Associates, Llc Recruiting
Trumbull, Connecticut, United States, 06611
Contact: Geoffrey Gladstein, Site 015    203-374-9816      
United States, Florida
Local Institution Not yet recruiting
Sarasota, Florida, United States, 34239
Contact: , Site 010         
United States, Illinois
Local Institution Not yet recruiting
Quincy, Illinois, United States, 62301
Contact: , Site 014         
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02111
Contact: , Site 059         
United States, Mississippi
Arthritis Associates Of Mississippi Recruiting
Jackson, Mississippi, United States, 39202
Contact: Neal I. Shparago, Site 005    601-353-7090      
United States, North Carolina
Box Arthritis And Rheumatology Of The Carolinas, Pllc Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Emily Jane Herron Box, Site 011    704-541-9092      
United States, Oklahoma
Health Research Of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73103
Contact: Christine Ellen Codding, Site 001    405-702-6770      
United States, Pennsylvania
East Penn Rheumatology Associates, P.C. Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Charles L. Ludivico, Site 012    601-868-1336      
Local Institution Not yet recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: , Site 006         
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98104
Contact: , Site 007         
Argentina
Local Institution Recruiting
Capital Federal, Buenos Aires, Argentina, 1425
Contact: , Site 053         
Local Institution Not yet recruiting
Capital Federal, Buenos Aires, Argentina, 1015
Contact: , Site 054         
Local Institution Recruiting
Capital Federal, Buenos Aires, Argentina, 1428
Contact: , Site 055         
Local Institution Recruiting
Tucuman, Argentina, 4000
Contact: , Site 052         
Australia, Queensland
Local Institution Not yet recruiting
Cairns, Queensland, Australia, 4870
Contact: , Site 016         
Local Institution Not yet recruiting
Maroochydore, Queensland, Australia, 4558
Contact: , Site 018         
Australia, South Australia
Local Institution Not yet recruiting
Woodville, South Australia, Australia, 5011
Contact: , Site 034         
Australia, Victoria
Local Institution Not yet recruiting
Box Hill, Victoria, Australia, 3128
Contact: , Site 057         
Australia, Western Australia
Local Institution Not yet recruiting
Shenton Park, Western Australia, Australia, 6008
Contact: , Site 017         
Canada, Manitoba
Local Institution Not yet recruiting
Winnipeg, Manitoba, Canada, R3A 1M3
Contact: , Site 061         
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H2L 1S6
Contact: , Site 060         
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Rimouski, Quebec, Canada, G5L 8W1
Contact: , Site 058         
Local Institution Not yet recruiting
Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Contact: , Site 0076         
Czech Republic
Local Institution Not yet recruiting
Pardubice, Czech Republic, 53001
Contact: , Site 063         
Local Institution Not yet recruiting
Praha 2, Czech Republic, 12850
Contact: , Site 062         
France
Local Institution Not yet recruiting
Lille Cedex, France, 59037
Contact: , Site 030         
Local Institution Not yet recruiting
Montpellier, France, 34295
Contact: , Site 029         
Local Institution Not yet recruiting
Orleans, France, 45032
Contact: , Site 031         
Local Institution Not yet recruiting
Strasbourg Cedex, France, 67098
Contact: , Site 027         
Germany
Local Institution Not yet recruiting
Bad Nauheim, Germany, 61231
Contact: , Site 004         
Local Institution Recruiting
Erlangen, Germany, 91054
Contact: , Site 002         
Local Institution Not yet recruiting
Herne, Germany, 44652
Contact: , Site 003         
Local Institution Not yet recruiting
Planegg, Germany, 82152
Contact: , Site 026         
Hungary
Local Institution Not yet recruiting
Budapest, Hungary, 1062
Contact: , Site 067         
Local Institution Not yet recruiting
Budapest, Hungary, 1023
Contact: , Site 066         
Local Institution Not yet recruiting
Debrecen, Hungary, 4012
Contact: , Site 068         
Local Institution Not yet recruiting
Veszprem, Hungary, 8200
Contact: , Site 065         
Italy
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Firenze, Italy, 50139
Contact: , Site 072         
Local Institution Not yet recruiting
Napoli, Italy, 80131
Contact: , Site 049         
Local Institution Not yet recruiting
Prato, Italy, 59100
Contact: , Site 050         
Local Institution Not yet recruiting
Roma, Italy, 00161
Contact: , Site 051         
Mexico
Local Institution Not yet recruiting
Mexico, Aguascalientes, Mexico, 20127
Contact: , Site 073         
Local Institution Not yet recruiting
Zapopan, Jalisco, Mexico, 45190
Contact: , Site 071         
Local Institution Not yet recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: , Site 075         
Local Institution Not yet recruiting
Distrito Federal, Mexico, 14080
Contact: , Site 074         
Poland
Local Institution Not yet recruiting
Bialystok, Poland, 15-351
Contact: , Site 020         
Local Institution Not yet recruiting
Dabrowka, Poland, 62-069
Contact: , Site 024         
Local Institution Not yet recruiting
Elblag, Poland, 82-300
Contact: , Site 070         
Local Institution Not yet recruiting
Katowice, Poland, 40-748
Contact: , Site 069         
Local Institution Not yet recruiting
Poznan, Poland, 60-773
Contact: , Site 019         
Local Institution Not yet recruiting
Warszawa, Poland, 02-637
Contact: , Site 023         
Local Institution Not yet recruiting
Warszawa, Poland, 01-868
Contact: , Site 021         
Local Institution Not yet recruiting
Wroc£Aw, Poland, 50-088
Contact: , Site 032         
Russian Federation
Local Institution Not yet recruiting
Moscow, Russian Federation, 115522
Contact: , Site 041         
Local Institution Not yet recruiting
Yaroslavl, Russian Federation, 150003
Contact: , Site 042         
South Africa
Local Institution Not yet recruiting
Pretoria, Gauteng, South Africa, 0084
Contact: , Site 038         
Local Institution Not yet recruiting
Pretoria, Gauteng, South Africa, 0083
Contact: , Site 039         
Local Institution Not yet recruiting
Durban, Kwa Zulu Natal, South Africa, 4001
Contact: , Site 037         
Local Institution Not yet recruiting
Panorama, Cape Town, Western Cape, South Africa, 7500
Contact: , Site 035         
Local Institution Not yet recruiting
Pinelands, Western Cape, South Africa, 7405
Contact: , Site 036         
Spain
Local Institution Recruiting
A Coruna, Spain, 15006
Contact: , Site 040         
Local Institution Recruiting
Barcelona, Spain, 08036
Contact: , Site 048         
Local Institution Recruiting
Sevilla, Spain, 41071
Contact: , Site 047         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb 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 April 16, 2014