Comparing Abatacept and Tocilizumab for Rheumatoid Arthritis Treatment
Abatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority Trial
This study is testing whether abatacept or tocilizumab works better for adults with rheumatoid arthritis who haven't improved with other treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lille Catholic University Academic / other |
| Drugs / interventions | prednisone, tocilizumab, rituximab |
| Locations | 26 sites (Lomme, Hauts De France and 25 other locations) |
| Trial ID | NCT03227419 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two biological agents, abatacept and tocilizumab, in treating rheumatoid arthritis (RA) in patients who have not responded adequately to TNF inhibitors. The study focuses on patients over 18 years old who meet specific criteria for RA and have shown moderate to high disease activity despite previous treatment. Participants will receive either drug via subcutaneous administration, allowing for outpatient care. The trial aims to determine which of the two treatments provides better outcomes for patients with severe RA.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with rheumatoid arthritis who have not responded adequately to TNF inhibitors.
Not a fit: Patients who have previously experienced intolerance to TNF inhibitors or have contraindications for either drug will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with more effective treatment options for managing their rheumatoid arthritis.
How similar studies have performed: Other studies have shown promising results with similar biological agents, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \>18 years * RA according to the ACR/EULAR 2010 criteria * inadequate response to a subcutaneously administered first-line TNFi defined as moderate to high disease activity (DAS28-ESR\>3.2 and CDAI\>10) after at least 3 months of treatment with a TNFi * beneficiary of the French National Health Insurance Fund * signed informed consent form * for women of childbearing age: effective contraception during treatment period with engagement to continue such contraception for 14 weeks after last administration Exclusion Criteria: * counter-indication for one or other of the two drugs under study * prior failure of the TNFi due to intolerance * receiving ≥15 mg/day prednisone for more than 4 weeks * pregnant or nursing women
Where this trial is running
Lomme, Hauts De France and 25 other locations
- Hôpital Saint-Philibert — Lomme, Hauts De France, France (Recruiting)
- Hôpital Avicenne — Bobigny, France (Recruiting)
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- CH de Boulogne-sur-Mer — Boulogne-sur-Mer, France (Recruiting)
- Ch Cahors — Cahors, France (Recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CHU de Grenoble Hôpital Sud — Grenoble, France (Recruiting)
- CHD Vendée — La Roche-sur-Yon, France (Recruiting)
- Hôpital Bicêtre — Le Kremlin-Bicêtre, France (Recruiting)
- CHRU de Lille — Lille, France (Recruiting)
- Clinique Infirmerie Protestante de Lyon — Lyon, France (Recruiting)
- CHU de Montpellier — Montpellier, France (Recruiting)
- CHU Nice — Nice, France (Recruiting)
- CHU Bichat — Paris, France (Recruiting)
- Hôpital Cochin — Paris, France (Recruiting)
- Hôpital de la Pitié-Salpêtrière — Paris, France (Recruiting)
- Hôpital Lariboisière — Paris, France (Recruiting)
- CHU de Poitiers — Poitiers, France (Recruiting)
- CH René-Dubos — Pontoise, France (Recruiting)
- CHU de Reims — Reims, France (Recruiting)
- CHU Rouen — Rouen, France (Recruiting)
- CHU de Saint-Etienne — Saint-Étienne, France (Recruiting)
- CHU Saint-Etienne — Saint-Étienne, France (Recruiting)
- CHRU de Strasbourg — Strasbourg, France (Recruiting)
- CHU de Tours — Tours, France (Recruiting)
- CH de Valenciennes — Valenciennes, France (Recruiting)
Study contacts
- Principal investigator: Pascart Tristan, MD — Ghicl
- Study coordinator: Amélie Lansiaux, MD, PhD
- Email: lansiaux.amelie@ghicl.net
- Phone: 03 20 22 52 69
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.