PoC in Rheumatoid Arthritis With Methotrexate

This study has been completed.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
First received: January 18, 2008
Last updated: September 23, 2015
Last verified: September 2015
The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate

Condition Intervention Phase
Rheumatoid Arthritis, NOS
Drug: BMS-582949
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12 [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects achieving an ACR 20 [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
  • Proportion of subjects schieving and ACR 50 [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
  • Proportion of subjects schieving and ACR 70 [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
  • Percent change from baseline to each scheduled visit in DAS28 score [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
  • Percent change from baseline to each scheduled visit in ACR scores [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
  • Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
  • Percent change from baseline to each scheduled visit in HAQ score [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: BMS-582949
Tablets, Oral, 300 mg, once daily, 12 weeks
Other Name: P38 Inflamation
Placebo Comparator: P1 Drug: Placebo
Tablets, Oral, placebo, once daily, 12 weeks


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

Inclusion Criteria:

  • Must have a diagnosis of RA for at least 6 months
  • Must be taking methotrexate for at least 3 months & on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
  • Must have at least 6 swollen and at least 8 tender joints
  • CRP above upper limit of normal or ESR > 28 mm/hr
  • Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication

Exclusion Criteria:

  • Any infection including TB, HIV, Hepatitis B or C
  • Recent infection requiring antibiotics within 4 weeks
  • History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
  • Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)
  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: NCT00605735

  Show 28 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00605735     History of Changes
Other Study ID Numbers: IM119-015 
Study First Received: January 18, 2008
Last Updated: September 23, 2015
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
Korea: Food and Drug Administration
Mexico: Federal Commission for Sanitary Risks Protection
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Czech Republic: State Institute for Drug Control
Taiwan: Department of Health

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 26, 2016