At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)
In Brief
A Phase 4 clinical trial evaluating Etanercept and Placebo for Rheumatoid Arthritis. Completed, enrolled 91 participants across 16 sites in 6 countries.
Detailed Summary
This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.
Study Details
Timeline
Interventions
50 mg etanercept once weekly + methotrexate
25mg etanercept once weekly + methotrexate
Placebo comparator once weekly + methotrexate