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PoC in Rheumatoid Arthritis With Methotrexate

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00605735
First received: January 18, 2008
Last updated: January 24, 2011
Last verified: October 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605735

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

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: January 24, 2011
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
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013