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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162292
First received: September 9, 2005
Last updated: February 27, 2010
Last verified: August 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014