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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people who have been recently diagnosed with rheumatoid arthritis (RA) and have never taken a medicine called methotrexate before. Rheumatoid arthritis causes painful joint swelling and can permanently damage joints over time. This trial tests whether combining abatacept (a medicine that calms the immune system) with methotrexate works better than methotrexate alone in slowing joint damage and achieving remission (a state where the disease is no longer active). You may be eligible if: - You are 18 years or older - You have been diagnosed with rheumatoid arthritis within the past 2 years - You have never been treated with methotrexate before - Your X-rays show joint damage (erosions) - Your blood tests show elevated CRP (8.0 mg/L or above) and you are positive for rheumatoid factor or anti-CCP antibodies You may NOT be eligible if: - You (or your partner) are not willing to use birth control during the study - You have been diagnosed with another rheumatic disease - You have had a cancer diagnosis in the past 5 years - You have active tuberculosis - You have been treated with another investigational drug in the past 28 days - You have an active bacterial or viral infection Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


Locations(1)

Australia

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