At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effectiveness of a Combination of Methotrexate and a Step Down Glucocorticoid Regimen (COBRA-Slim) for Remission Induction in Patients With Early Rheumatoid Arthritis (RA), With or Without Fast Access to 24 Weeks of Tumor Necrosis Factor (TNF) Blockade in Insufficient Responders, a Randomized, Multicenter, Pragmatic Trial
In Brief
A Phase 4 clinical trial evaluating Etanercept 50 MG/ML and Leflunomide 10 milligram (MG) for Arthritis, Rheumatoid. Completed, enrolled 276 participants across 19 sites.
Detailed Summary
In the Care in Rheumatoid Arthritis (CareRA) trial (NCT01172639) about 70% of early RA patients are in remission at the 2 year evaluation point independent of the combination scheme used. Interesting to see is that the 30% of insufficient responders can be identified in an early stage of the treatment course. The purpose of the present study is to investigate if, for patients with an insufficient response to a COBRA-Slim regimen, accelerated access to a short course of anti-TNF therapy already early after treatment initiation (from w8 until w32) could improve outcomes compared to a more traditional treat to target sequence.
Study Details
Timeline
Interventions
Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
Leflunomide 10mg PO daily added to the COBRA-Slim scheme