Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. Optimized Treatment Algorithms for Patients with Early RA
In newly diagnosed rheumatoid arthritis patients it is recommended to treat as soon as possible with methotrexate and steroids However, this treatment algorithm, will only bring one third of the patients into remission and cannot stop progressive, persistent joint damage. The possible benefits and risks of adding adalimumab to this conventional treatment algorithm is unknown. The aim of the study is to clarify the possible benefits of adding adalimumab an anti-TNF-alfa inhibitor versus placebo to the treatment of rheumatoid arthritis patients, who are treated very early and given methotrexate and intraarticular triamcinolone hexacetonide. Efficacy will be evaluated by DAS 28, ACR 20/50/70, HAQ, progressive changes in X-ray, MRI and DXA-scans. Adverse events will also be registered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Adalimumab injection 0.8 ml (40 mg) s.c. every second week in up to 2 years
Saline injection 0.9%, 0.8 ml s.c. every second week up to 2 years
Aarhus University Hospital
Aarhus, Denmark
Number of patients who achieve a DAS28 < 3.2
Time frame: 0, 1, 3, 6, 9, 12 and 24 months (DAS28)
Changes in DAS28 from start of treatment
Time frame: 1, 3, 6, 9, 12 and 24 months
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