Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162292
First received: September 9, 2005
Last updated: February 27, 2010
Last verified: August 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: BMS-582949 and Methotrexate |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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 [ Time Frame: 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
| Estimated Enrollment: | 33 |
| Study Start Date: | November 2005 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162292
Locations
| United States, California | |
| Desert Medical Advances | |
| Palm Desert, California, United States, 92260 | |
| Boling Clinical Trials | |
| Upland, California, United States, 91786 | |
| United States, Florida | |
| Delray Research Associates | |
| Delray Beach, Florida, United States, 33484 | |
| Ocala Rheumatology Research Center | |
| Ocala, Florida, United States, 34474 | |
| United States, Massachusetts | |
| Phase Iii Clinical Research | |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Texas | |
| Covance Clinical Research Unit Inc. | |
| Dallas, Texas, United States, 75247 | |
| Radiant Research San Antonio Northeast | |
| San Antonio, Texas, United States, 78217 | |
| Healthcare Discoveries, Inc | |
| San Antonio, Texas, United States, 78229 | |
| Mexico | |
| Local Institution | |
| Metepec, Estado De Mexico, Mexico, 52140 | |
| Local Institution | |
| Leon, Guanajuato, Mexico, 37520 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00162292 History of Changes |
| Other Study ID Numbers: | IM119-010 |
| Study First Received: | September 9, 2005 |
| Last Updated: | February 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013