Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background

February 27, 2010 updated by: Bristol-Myers Squibb
The purpose of this clinical research study is to learn if it is safe for rheumatoid arthritis patients to take BMS-582949 along with methotrexate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Phase 1

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

  • Mexico
    • Estado De Mexico
      • Metepec, Estado De Mexico, Mexico, 52140
        • Local Institution
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37520
        • Local Institution
  • United States
    • California
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
      • Upland, California, United States, 91786
        • Boling Clinical Trials
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Delray Research Associates
      • Ocala, Florida, United States, 34474
        • Ocala Rheumatology Research Center
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Phase III Clinical Research
    • Texas
      • Dallas, Texas, United States, 75247
        • Covance Clinical Research Unit Inc.
      • San Antonio, Texas, United States, 78217
        • Radiant Research San Antonio Northeast
      • San Antonio, Texas, United States, 78229
        • Healthcare Discoveries, Inc

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-70 years
  • Diagnosis of RA for ≥6 months
  • Swollen or tender joint or ESR >ULN. Subject must be on stable doses of MTX
  • Women of Childbearing Potential

Exclusion Criteria:

  • Serum transaminase levels >ULN
  • CK>ULN
  • Cannot have taken Orencia or Remicade within 8 weeks of baseline, Humira or Enbrel within 4 weeks of baseline
  • Use of H2 blockers or Proton Pump inhibitors while on study

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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate safety and tolerability of BMS-582949 in subjects with active rheumatoid arthritis receiving concomitant MTX at steady state
Time Frame: during 28 doses of treatment
during 28 doses of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the PK of BMS-582949 in clinically stable RA subjects on stable doses of MTX and concomitant BMS-582949
To explore DAS28, ESR, RF and CRP of clinically stable doses of MTX and concomitant BMS-582949 compared to MTX alone
Time Frame: during 28 days of treatment
during 28 days of treatment
To evaluate PK of MTX in stable RA subjects in the absence and presence of BMS-582949 for subjects enrolled prior to approval of amendment 2

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

November 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM119-010

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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