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Clinical Trial Summary

Approximately, 40 to 50% of patients with rheumatoid arthritis (RA), the most frequent inflammatory arthritide, are non responders to the consensual 1st line of treatment : methotrexate. In these patients, it is well demonstrated that the addition of other immunomodulatory drug(s) often results in a significant improvement. However, the best option regarding the drug(s) to add remains unclear. Rheumatologists are currently used to adding a targeted therapy, such as anti-TNFα, and more recently abatacept or tocilizumab. Triple therapy using 3 conventional disease-modifying drugs (DMARDs), methotrexate or leflunomide+salazopyrine+hydroxychloroquine could be an alternative option to targeted therapies, all the more as they have a more favorable safety profile and a much lower cost. Uncertainty remains regarding the superiority of targeted therapies on triple therapy in methotrexate or leflunomide insufficient responders (IR). Investigators decided to address this issue by performing a randomized controlled pragmatic trial.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02714634
Study type Interventional
Source University Hospital, Strasbourg, France
Contact Jacques-Eric GOTTENBERG, Professor
Phone 3 88 12 79 53
Email jacques-eric.gottenberg@chru-strasbourg.fr
Status Recruiting
Phase Phase 4
Start date March 30, 2016
Completion date March 2025

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