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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

Phase 3
Recruiting
Conditions
Rheumatoid Arthritis (RA)
Inflammatory and Immune System - Rheumatoid arthritis
Registration Number
ACTRN12605000784617
Lead Sponsor
Bristol-Myers Squibb Australia
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
500
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.

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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