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

NCT03649061 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2025-06-19

Study results available
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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

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

Sponsors & Collaborators

  • Belgium Health Care Knowledge Centre

    collaborator OTHER_GOV

  • P. Verschueren

    lead OTHER

Principal Investigators

  • Patrick Verschueren, MD, PhD · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-08
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649061 on ClinicalTrials.gov