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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: BMS-582949 and Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162292

IM119-010

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind