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PoC in Rheumatoid Arthritis With Methotrexate

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00605735
First Posted: January 31, 2008
Last Update Posted: October 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Proportion of subjects achieving an ACR 20 [ Time Frame: at each scheduled visit ]
  • Proportion of subjects schieving and ACR 50 [ Time Frame: at each scheduled visit ]
  • Proportion of subjects schieving and ACR 70 [ Time Frame: at each scheduled visit ]
  • Percent change from baseline to each scheduled visit in DAS28 score [ Time Frame: at each scheduled visit ]
  • Percent change from baseline to each scheduled visit in ACR scores [ Time Frame: at each scheduled visit ]
  • Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue [ Time Frame: at each scheduled visit ]
  • Percent change from baseline to each scheduled visit in HAQ score [ Time Frame: at each scheduled visit ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605735


  Show 28 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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
First Submitted: January 18, 2008
First Posted: January 31, 2008
Last Update Posted: October 12, 2015
Last Verified: September 2015

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
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


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