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Study identifier: NCT02714634 Synced from ClinicalTrials.gov · July 29, 2026
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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

Condition: Rheumatoid Arthritis · Insufficient Response to Methotrexate or Leflunomide  ·  Sponsor: University Hospital, Strasbourg, France

PhasePhase 4
Planned participants286
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Jacques-Eric GOTTENBERG, Professor  ·  3 88 12 79 53  ·  jacques-eric.gottenberg@chru-strasbourg.fr

Always discuss trial participation with your own doctor first.

Locations (1)

Hôpitaux Universitaires de StrasbourgStrasbourg, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT02714634