CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 91 enrolled
Drug / intervention
Etanercept +2 moredrug
Likely dose
Etanercept 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00858780
NCT00858780Phase 4Completed

Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)

Pfizer·interventional·Posted Mar 10, 2009·Updated Sep 11, 2013

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark, Finland, Hungary, Iceland, Norway, Sweden
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 10, 2009
Enrollment StartJan 1, 2009
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.3 years ago

Interventions

Etanerceptdrug

50 mg etanercept once weekly + methotrexate

Etanerceptdrug

25mg etanercept once weekly + methotrexate

Placebodrug

Placebo comparator once weekly + methotrexate