NCT00162292CompletedPhase 1
Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background
Bristol-Myers Squibb10 sites in 2 countries33 target enrollmentStarted: November 1, 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 33
- Locations
- 10
- Primary Endpoint
- To evaluate safety and tolerability of BMS-582949 in subjects with active rheumatoid arthritis receiving concomitant MTX at steady state
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Untitled Study
Intervention: BMS-582949 and Methotrexate (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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
Investigators
Study Sites (10)
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