Comparing targeted therapy with triple therapy for rheumatoid arthritis patients not responding to standard treatments
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
This study is testing whether adding a targeted therapy to existing medications works better than using a combination of traditional drugs for people with rheumatoid arthritis who haven't felt better with standard treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | methotrexate, prednisone, tocilizumab |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT02714634 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of adding targeted therapy to methotrexate or leflunomide versus using a combination of conventional disease-modifying drugs (DMARDs) in patients with rheumatoid arthritis who have not responded adequately to these first-line treatments. The study aims to determine which approach provides better outcomes for patients who have insufficient responses to methotrexate or leflunomide. Participants will receive either the targeted therapy or a triple therapy regimen, and their responses will be monitored over time to assess improvements in their condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with rheumatoid arthritis who have not responded adequately to methotrexate or leflunomide.
Not a fit: Patients who have previously been treated with targeted therapies or have contraindications to these treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with rheumatoid arthritis who do not respond to standard therapies.
How similar studies have performed: Other studies have shown varying success with similar approaches, but this specific comparison of targeted therapy versus triple therapy in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 months of treatment * RA radiographic erosions and/or serum rheumatoid factor associated to anti-Cyclic Citrullinated Peptide (Anti-CCP) * Age greater or equal to 18 years * Written informed consent, dated and signed before initiating any trial-related procedure * Affiliation to a social insurance system * Women of child bearing potential, negative β-HCG assay (Human chorionic gonadotropin) * Effective method of birth control during the study and continuing after the discontinuation of the investigational drug or study. The duration will depend on the drug used (referred to the summary product characteristic). Exclusion Criteria: * Previous treatment with or contraindication to targeted therapies (biologic or JAK/STAT inhibitor) * Previous treatment with triple therapy * Other inflammatory arthritis except RA associated with Sjögren's syndrome * Contraindication to all biologics/ JAK/STAT inhibitors or to methotrexate, leflunomide, sulfasalazine and hydroxychloroquine * Corticosteroids at a dose \>15 mg/d of equivalent prednisone for at least 4 weeks before the inclusion * Absence of tuberculosis screening * Patient who cannot be followed during 12 months * Pregnancy, breastfeeding, desire of pregnancy in the 12 months * Drug addiction, addiction to alcohol * Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment * Women of child bearing potential, unless they are using an effective method of birth control * Patient under law protection * Prisoners
Where this trial is running
Strasbourg
- Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Jacques-Eric GOTTENBERG, Professor
- Email: jacques-eric.gottenberg@chru-strasbourg.fr
- Phone: 3 88 12 79 53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.