Gradual Biologic Drug Reduction in Rheumatoid Arthritis Patients in Remission
Tests an individualized plan for lowering biologic drug doses in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Key facts
- Where
- Caluire-et-Cuire, Chambray Les Tours, La Roche Sur Yon Cedex 9, Lomme Cedex, Montpellier Cedex 5, Paris Cedex 13, Reims Cedex, and Saint-Priest-en-Jarez, FranceSee the 8 sites
- Phase
- Phase 4
Where in France
- Clinique de l'infirmerie ProtestanteCaluire-et-Cuire, FranceTaking people
- Centre Hospitalier Regional Universitaire De ToursChambray Les Tours, FranceTaking people
- Centre Hospitalier Departemental VendeeLa Roche Sur Yon Cedex 9, FranceTaking people
- Groupement Des Hopitaux De L'Institut Catholique De LilleLomme Cedex, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Hopitaux Universitaires Pitie SalpetriereParis Cedex 13, FranceTaking people
- Centre Hospitalier Universitaire ReimsReims Cedex, FranceTaking people
- Centre Hospitalier Universitaire de Saint EtienneSaint-Priest-en-Jarez, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire de Saint Etienne
- Trial code
- NCT06528431EU 2024-514313-35-00
- Record updated
- 26 December 2025
- Original description
Rheumatoid arthritis (RA) is the most common inflammatory joint disorder. Since twenty year and the use of synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biological (b)DMARD, remission can be reached. When remission is obtained, the physician has no recommendations for managing a step-down, and future guidelines will be useful to assist the clinician. Recent data suggest that tapering is feasible, but with high risk of flares. Flares are less frequent when bDMARD blood concentration is high. But, the optimal adalimumab concentration to keep before a step of tapering no targeting personal is unknown.Read full original descriptionShow less
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Rheumatoid arthritis (RA) is the most common inflammatory joint disorder. Since twenty year and the use of synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biological (b)DMARD, remission can be reached. When remission is obtained, the physician has no recommendations for managing a step-down, and future guidelines will be useful to assist the clinician. Recent data suggest that tapering is feasible, but with high risk of flares. Flares are less frequent when bDMARD blood concentration is high. But, the optimal adalimumab concentration to keep before a step of tapering no targeting personal is unknown.
Inclusion: 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: Any dose of prednisone for RA treatment 6 months before inclusion; 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; Patient deprived of liberty or patient under guardianship or curator ship.