RecruitingPhase 3ACTRN12605000784617

A Phase IIIB Multi-Center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

Sponsor

Bristol-Myers Squibb Australia

Enrollment

500 participants

Start Date

Jan 1, 2006

Study Type

Interventional

Conditions

Rheumatoid Arthritis (RA)

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Diagnosis of rheumatoid arthritis (RA) <2 years; never received treatment with methotrexate; erosions noted on x-ray. CRP >= 8.0 mg/L Rheumatoid factor or anti CCP positive.

Exclusion Criteria1

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.

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Interventions

Drug: Abatacept plus methotrexate for the first 12 months. Month 12 to 24, subjects previously treated with Abatacept plus methotrexate remain on this same treatment. Study Design: Treatment, Random

Drug: Abatacept plus methotrexate for the first 12 months. Month 12 to 24, subjects previously treated with Abatacept plus methotrexate remain on this same treatment. Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study