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

INTERVENTION:

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

CONDITION:

Rheumatoid Arthritis (RA)

PRIMARY OUTCOME:

Joint damage progression measured by radiographic evaluation using the Genantâ Modified Sharp total score The proportion of subjects who achieve remission in 12 months of treatment as defined by a DAS 28 score less that 2.6.

SECONDARY OUTCOME:

Assess the inhibition of joint damage progression measured by radiographic evaluation using the Genant‐modified Sharp erosion, joint space narrowing and total score. Compare the disease activity as measured by DAS 28 score. Compare the improvement in health‐related quality of life using SF‐36. Compare the improvement in physical function using the HAQ disability index. Compare the inhibition of joint damage progression measured by radiographic evaluation using the Genant‐modified Sharp erosion, and joint space narrowing. Compare the proportion of subjects achieving major clinical response defined by 6 months of consecutive ACR 70 response. Compare the proportion of subjects with an ACR50 response. Determine the safety and tolerability of abatacept in this subject population, including evaluation of immunogenicity of abatacept.

INCLUSION CRITERIA:

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.