Actively Recruiting
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
Led by University Hospital, Strasbourg, France · Updated on 2025-03-12
286
Participants Needed
1
Research Sites
674 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria
- DAS28-CRP >3.2
- Insufficient response to methotrexate at a weekly dose ≥15 mg after at least 3 months or to leflunomide at 10 to 20 mg per day after 3 months
- Presence of RA radiographic erosions and/or serum rheumatoid factor associated with anti-Cyclic Citrullinated Peptide (Anti-CCP)
- Age 18 years or older
- Signed written informed consent before any trial-related procedure
- Affiliated to a social insurance system
- Women of childbearing potential must have a negative β-HCG test
- Use of an effective method of birth control during the study and continuing after discontinuation of the study drug as specified
You will not qualify if you...
- Previous treatment with or contraindication to targeted therapies (biologic or JAK/STAT inhibitor)
- Previous treatment with triple therapy
- Other inflammatory arthritis except RA with Sjögren's syndrome
- Contraindication to all biologics/JAK/STAT inhibitors or to methotrexate, leflunomide, sulfasalazine, and hydroxychloroquine
- Corticosteroid dose >15 mg/day prednisone equivalent for at least 4 weeks before inclusion
- No tuberculosis screening
- Inability to be followed for 12 months
- Pregnancy, breastfeeding, or desire for pregnancy within 12 months
- Drug or alcohol addiction
- Participation in another clinical study with an investigational product within 4 weeks before study treatment
- Women of childbearing potential not using effective birth control
- Patients under legal protection
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67098
Actively Recruiting
Research Team
J
Jacques-Eric GOTTENBERG, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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