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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00162292
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Study Start: 2005-11
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-08
• Disposition First Submitted: 2010-02-27
• Disposition First Submitted QC: 2010-02-27
• Last Update Submitted: 2010-02-27
• Disposition First Posted: 2010-03-02
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (9)

Desert Medical Advances; 🇺🇸 Palm Desert, California, United States

Boling Clinical Trials; 🇺🇸 Upland, California, United States

Delray Research Associates; 🇺🇸 Delray Beach, Florida, United States

Ocala Rheumatology Research Center; 🇺🇸 Ocala, Florida, United States

Phase Iii Clinical Research; 🇺🇸 Fall River, Massachusetts, United States

Covance Clinical Research Unit Inc.; 🇺🇸 Dallas, Texas, United States

Radiant Research San Antonio Northeast; 🇺🇸 San Antonio, Texas, United States

Healthcare Discoveries, Inc; 🇺🇸 San Antonio, Texas, United States

Local Institution; 🇲🇽 Leon, Guanajuato, Mexico