Arthritis, Rheumatoid Clinical Trial
Official title:
Optimized Treatment Algorithm in Early Rheumatoid Arthritis: Methotrexate and Intra-articular Glucocorticosteroid Plus Adalimumab or Placebo in the Treatment of Early Rheumatoid Arthritis
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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