Individualized tapering strategy for rheumatoid arthritis treatment
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
This study is testing a personalized plan for reducing medication in people with rheumatoid arthritis who are in remission to see if it helps prevent flare-ups.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Drugs / interventions | prednisone, adalimumab |
| Locations | 8 sites (Caluire-et-Cuire and 7 other locations) |
| Trial ID | NCT06528431 on ClinicalTrials.gov |
What this trial studies
This study evaluates a personalized tapering strategy for patients with rheumatoid arthritis who have achieved remission while being treated with adalimumab. It aims to determine the optimal blood concentration of adalimumab before initiating a tapering process to minimize the risk of disease flares. The approach utilizes a step wedge trial design to assess the effectiveness of this individualized strategy in managing treatment. By understanding the best tapering practices, the study seeks to provide clearer guidelines for clinicians.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with rheumatoid arthritis in remission for at least six months while on adalimumab treatment.
Not a fit: Patients currently experiencing active rheumatoid arthritis symptoms or those who have not achieved remission may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help patients maintain remission while reducing their medication dosage, potentially minimizing side effects and healthcare costs.
How similar studies have performed: Previous studies have indicated that tapering biological treatments can be feasible, but this specific individualized approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years of age * Patients with a diagnosis of RA according to ACR/EULAR 2010 criteria * Remission according to DAS28\<=2.6 for at least 6 months * Patient treated with ADA for at least 6 months. The patient is treated according to one of the following two strategies: * ADA 40 mg every two weeks (= every 14 days) according to the standard regimen * or ADA 40 mg every 3 weeks (= every 21 days) * A negative highly sensitive pregnancy test for women of Childbearing Potential\* * Affiliated person or beneficiary of a social security scheme * Informed consent signed by the patient after information Exclusion Criteria: * Incapacity or refusal to understand and / or sign informed consent to participate in the study. * Existing pregnancy, lactation, or intended pregnancy within the next 15 months * Fibromyalgia associated to RA * Any dose of prednisone for RA treatment 6 months before inclusion * Patient deprived of liberty or patient under guardianship or curator ship.
Where this trial is running
Caluire-et-Cuire and 7 other locations
- Infirmerie Protestante — Caluire-et-Cuire, France (Recruiting)
- Chd Vendee — La Roche-sur-Yon, France (Recruiting)
- Hopital Philibert — Lomme, France (Recruiting)
- Chu Montpellier — Montpellier, France (Recruiting)
- Ap-Hp Pitie Salpetriere — Paris, France (Recruiting)
- Chu Reims — Reims, France (Not_yet_recruiting)
- Chu Saint Etienne — Saint-Etienne, France (Recruiting)
- Chru Tours — Tours, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Hubert MAROTTE, MD PhD
- Email: hubert.marotte@chu-st-etienne.fr
- Phone: (0)4 77 12 76 49
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.