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
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)
Local Institution
🇲🇽Leon, Guanajuato, Mexico
Delray Research Associates
🇺🇸Delray Beach, Florida, United States
Phase Iii Clinical Research
🇺🇸Fall River, Massachusetts, United States
Boling Clinical Trials
🇺🇸Upland, California, United States
Ocala Rheumatology Research Center
🇺🇸Ocala, Florida, United States
Covance Clinical Research Unit Inc.
🇺🇸Dallas, Texas, United States
Radiant Research San Antonio Northeast
🇺🇸San Antonio, Texas, United States
Desert Medical Advances
🇺🇸Palm Desert, California, United States
Healthcare Discoveries, Inc
🇺🇸San Antonio, Texas, United States