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
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
University Hospital, Strasbourg, France
286 participants
Mar 30, 2016
INTERVENTIONAL
Conditions
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.
Eligibility
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Interventions
* Methotrexate or leflunomide + adalimumab or * Methotrexate or leflunomide + certolizumab or * Methotrexate or leflunomide + etanercept or * Methotrexate or leflunomide + golimumab or * Methotrexate or leflunomide + infliximab or * Methotrexate or leflunomide + abatacept or * Methotrexate or leflunomide + rituximab or * Methotrexate or leflunomide + tocilizumab or * Methotrexate or leflunomide + sarilumab or * Methotrexate or leflunomide + filgotinib or * Methotrexate or leflunomide + upadacitinib or * Methotrexate or leflunomide + Tofacitinib or * Methotrexate or leflunomide + baricitinib
Locations(1)
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NCT02714634