Remission and Joint Damage Progression in Early Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of rheumatoid arthritis (RA) <=2 years; MTX naive or <=10 mg/wk for <=3 weeks. No dose within 3 months prior to informed consent.

• C-Reactive Protein (CRP) >= 4.5 mg/L (after amendment)

• Rheumatoid factor or anti-cyclic citrullinated peptide antibody (anti-CCP) positive

• Tender joints >=12 and swollen joints >=10

Exclusion Criteria:

• Women and men who are not willing to use birth control

• Diagnosed with other rheumatic disease

• History of cancer within 5 years

• Active tuberculosis

• Treatment with another investigation drug within 28 days

• Active bacterial or viral infection