CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 400 enrolled
Drug / intervention
Methotrexate +3 moredrug
Likely dose
Not stated in 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/NCT01172639
NCT01172639Phase 4Completed

A 2 Year Prospective Multicentre Randomised Controlled Trial Comparing Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

P. Verschueren·interventional·Posted Jul 30, 2010·Updated Jan 22, 2019

In Brief

A Phase 4 clinical trial evaluating Methotrexate, Sulfasalazine, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 400 participants across 17 sites.

Detailed Summary

The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study introduced the principle of fast remission induction by means of a combination of standard Disease Modifying AntiRheumatic Drugs (DMARDs) and a step down bridge therapy with high dose glucocorticoids in early Rheumatoid Arthritis. The purpose of the present study is to compare different combinations of traditional DMARDs and glucocorticoids, based on the original CoBRA protocol, for treatment of early Rheumatoid Arthritis. Besides the efficacy and effectiveness of these strategies, patient centered outcomes and potential implementation problems of such treatment strategies are evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 30, 2010
Enrollment StartFeb 1, 2009
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 15.9 years ago

Interventions

Methotrexatedrug

Methotrexate tablet

Sulfasalazinedrug

Sulfasalazine tablet

Leflunomidedrug

Leflunomide tablet

Prednisonedrug

Prednisone tablet