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

NCT ID: NCT00162292

Last Updated: 2010-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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BMS-582949 and Methotrexate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Desert Medical Advances

Palm Desert, California, United States

Site Status

Boling Clinical Trials

Upland, California, United States

Site Status

Delray Research Associates

Delray Beach, Florida, United States

Site Status

Ocala Rheumatology Research Center

Ocala, Florida, United States

Site Status

Phase Iii Clinical Research

Fall River, Massachusetts, United States

Site Status

Covance Clinical Research Unit Inc.

Dallas, Texas, United States

Site Status

Radiant Research San Antonio Northeast

San Antonio, Texas, United States

Site Status

Healthcare Discoveries, Inc

San Antonio, Texas, United States

Site Status

Local Institution

León, Guanajuato, Mexico

Site Status

Local Institution

Metepec, State of Mexico, Mexico

Site Status

Countries

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United States Mexico

Other Identifiers

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IM119-010

Identifier Type: -

Identifier Source: org_study_id

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