NCT03649061

COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: P. Verschueren · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Etanercept 50 MG/ML	Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
DRUG	Leflunomide 10 milligram (MG)	Leflunomide 10mg PO daily added to the COBRA-Slim scheme

Timeline

• Start date: 2018-06-08
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2018-08-28
• Last updated: 2025-06-19
• Results posted: 2025-06-19

Locations

19 sites across 1 country: Belgium