PoC in Rheumatoid Arthritis With Methotrexate

September 23, 2015 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1426
        • Local Institution
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, 1431
        • Local Institution
      • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, C1034ACO
        • Local Institution
  • Czech Republic
      • Ceske Budejovice, Czech Republic, 370 01
        • Local Institution
      • Hradec Kralove, Czech Republic, 500 05
        • Local Institution
      • Prague 2, Czech Republic, 128 50
        • Local Institution
  • France
      • Bordeaux Cedex, France, 33076
        • Local Institution
      • Chambray Les Tours, France, 37170
        • Local Institution
      • Paris Cedex 14, France, 75679
        • Local Institution
  • Korea, Republic of
    • Choong Chung Nam-Do
      • Cheonan, Choong Chung Nam-Do, Korea, Republic of, 330-721
        • Local Institution
  • Mexico
      • Nuevo Leon, Mexico, 64020
        • Local Institution
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14080
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44500
        • Local Institution
      • Guadalajara, Jalisco, Mexico, 44200
        • Local Institution
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 8000
        • Local Institution
  • Spain
      • Madrid, Spain, 28046
        • Local Institution
      • Santiago De C., Spain, 15706
        • Local Institution
      • Vizcaya, Spain, 48903
        • Local Institution
  • Taiwan
      • Taichung, Taiwan, B
        • Local Institution
      • Taoyuan, Taiwan, 333
        • Local Institution
  • United States
    • California
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
      • Santa Monica, California, United States, 90404
        • Orrin M. Troum,M D
    • Nevada
      • Las Vegas, Nevada, United States, 81928
        • G. Timothy Kelly, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Health Research of Oklahoma
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19152
        • The Arthritis Group
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Arthritis Clinic
    • Texas
      • Austin, Texas, United States, 78705
        • Walter F Chase Md
    • Washington
      • Tacoma, Washington, United States, 98405
        • Tacoma Center For Arthritis Research Ps

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A1
Drug: BMS-582949
Tablets, Oral, 300 mg, once daily, 12 weeks
Other Names:
  • P38 Inflamation
PLACEBO_COMPARATOR: P1
Drug: Placebo
Tablets, Oral, placebo, once daily, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12
Time Frame: at Week 12
at Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving an ACR 20
Time Frame: at each scheduled visit
at each scheduled visit
Proportion of subjects schieving and ACR 50
Time Frame: at each scheduled visit
at each scheduled visit
Proportion of subjects schieving and ACR 70
Time Frame: at each scheduled visit
at each scheduled visit
Percent change from baseline to each scheduled visit in DAS28 score
Time Frame: at each scheduled visit
at each scheduled visit
Percent change from baseline to each scheduled visit in ACR scores
Time Frame: at each scheduled visit
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
at each scheduled visit
Percent change from baseline to each scheduled visit in HAQ score
Time Frame: at each scheduled visit
at each scheduled visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

January 18, 2008

First Submitted That Met QC Criteria

January 18, 2008

First Posted (ESTIMATE)

January 31, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM119-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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