Rheumatoid Arthritis Clinical Trial
Official title:
Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background
Verified date | August 2008 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 33 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Local Institution | Leon | Guanajuato |
Mexico | Local Institution | Metepec | Estado De Mexico |
United States | Covance Clinical Research Unit Inc. | Dallas | Texas |
United States | Delray Research Associates | Delray Beach | Florida |
United States | Phase Iii Clinical Research | Fall River | Massachusetts |
United States | Ocala Rheumatology Research Center | Ocala | Florida |
United States | Desert Medical Advances | Palm Desert | California |
United States | Healthcare Discoveries, Inc | San Antonio | Texas |
United States | Radiant Research San Antonio Northeast | San Antonio | Texas |
United States | Boling Clinical Trials | Upland | California |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To evaluate the PK of BMS-582949 in clinically stable RA subjects on stable doses of MTX and concomitant BMS-582949 | |||
Secondary | 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 | ||
Secondary | 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 |
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