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: September 12, 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 ]

Enrollment: 165
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

  Hide Study Locations
Locations
United States, California
San Diego Arthritis Medical Clinic
San Diego, California, United States, 92108
United States, Colorado
Denver Arthritis Clinic
Denver, Colorado, United States, 80230
United States, Connecticut
New England Research Associates, Llc
Trumbull, Connecticut, United States, 06611
United States, Florida
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239
United States, Mississippi
Arthritis Associates Of Mississippi
Jackson, Mississippi, United States, 39202
United States, North Carolina
Box Arthritis And Rheumatology Of The Carolinas, Pllc
Charlotte, North Carolina, United States, 28210
United States, Oklahoma
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, United States, 18015
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, 1425
Local Institution
Capital Federal, Buenos Aires, Argentina, 1428
Local Institution
Capital Federal, Buenos Aires, Argentina, 1015
Local Institution
Tucuman, Argentina, 4000
Australia, Queensland
Local Institution
Cairns, Queensland, Australia, 4870
Local Institution
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
Local Institution
Woodville, South Australia, Australia, 5011
Australia, Western Australia
Local Institution
Shenton Park, Western Australia, Australia, 6008
Canada, Manitoba
Manitoba Clinic
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H2L 1S6
Centre De Rhumatologie De L Est Du Quebec
Rimouski, Quebec, Canada, G5L 8W1
Centre De Recherche Musculo-Squelettique
Trois-rivieres, Quebec, Canada, G8Z 1Y2
Czech Republic
Local Institution
Pardubice, Czech Republic, 530 02
Local Institution
Praha 2, Czech Republic, 128 50
Germany
Local Institution
Bad Nauheim, Germany, 61231
Local Institution
Erlangen, Germany, 91054
Local Institution
Planegg, Germany, 82152
Hungary
Local Institution
Budapest, Hungary, 1023
Local Institution
Budapest, Hungary, 1062
Local Institution
Debrecen, Hungary, 4012
Local Institution
Veszprem, Hungary, 8200
Italy
Local Institution
Firenze, Italy, 50139
Local Institution
Napoli, Italy, 80131
Mexico
Local Institution
Mexico, Aguascalientes, Mexico, 20127
Local Institution
Zapopan, Jalisco, Mexico, 45190
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Poland
Local Institution
Bialystok, Poland, 15-351
Local Institution
Dabrowka, Poland, 62-069
Local Institution
Elblag, Poland, 82-300
Local Institution
Poznan, Poland, 60773
Local Institution
Warszawa, Poland, 01-868
Russian Federation
Local Institution
Moscow, Russian Federation, 115522
Local Institution
Yaroslavl, Russian Federation, 150003
South Africa
Local Institution
Pretoria, Gauteng, South Africa, 0084
Local Institution
Pretoria, Gauteng, South Africa, 0083
Local Institution
Durban, Kwa Zulu Natal, South Africa, 4001
Local Institution
Panorama, Cape Town, Western Cape, South Africa, 7500
Local Institution
Pinelands, Cape Town, Western Cape, South Africa, 7405
Spain
Local Institution
A Coruna, Spain, 15006
Local Institution
Barcelona, Spain, 08036
Local Institution
Sevilla, Spain, 41071
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: September 12, 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
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 September 18, 2014