Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Abatacept; Infliximab; Methotrexate

Criteria

Inclusion Criteria:

• Diagnosis of Rheumatoid Arthritis

• At least 3 months prior treatment with Methotrexate (MTX)

• At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl

• Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

Exclusion Criteria:

• participants who have failed more than 3 DMARDs

• participants previously treated with an approved biologic drug

• History of cancer in the last 5 years

• Severe or recurrent bacterial infection

• Any previous or current medical conditions that are contraindications to the use of TNF blocking agents

• Women of Child Bearing Potential