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Randomized Controlled Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Start Date
March 30, 2016
Primary Completion Date
March 1, 2029
Completion Date
March 1, 2029
Last Updated
March 12, 2025
286
ESTIMATED participants
Methotrexate + targeted therapy administration
DRUG
methotrexate or leflunomide + sulfasalazine + hydroxychloroquine administration
DRUG
Lead Sponsor
University Hospital, Strasbourg, France
NCT07484243
NCT06647069
Data Source & Attribution
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