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

Recruiting Phase 4 Interventional Study
Rheumatoid Arthritis Insufficient Response to Methotrexate or Leflunomide
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
286 (estimated)
Sponsor
University Hospital, Strasbourg, France · Other
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About This Trial
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. Rhe…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria * DAS28-CRP\>3.2 * Insufficient response to methotrexate at a weekly dose≥15mg after at least 3 months or to leflunomide at a dose of 10 (in case 20 mg are not well tolerated) to 20 mg per day after 3 month…
Contacts

Jacques-Eric GOTTENBERG, Professor

3 88 12 79 53

jacques-eric.gottenberg@chru-strasbourg.fr

CONTACT