RecruitingRecruiting
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
NCT06528431 · Centre Hospitalier Universitaire de Saint Etienne
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this 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.
Eligibility 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.
Study design
Enrollment target: 180 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-19
Estimated completion: 2027-12-19
Last updated: 2025-12-26
Interventions
Drug: Clinical tapering strategyDrug: Step Wedge trial
Primary outcomes
- • Rheumatoid arthritis flare-up (15 Months)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · other
With: AAP MESSIDOR
Contacts & investigators
ContactHubert MAROTTE, MD PhD · contact · hubert.marotte@chu-st-etienne.fr · (0)4 77 12 76 49
ContactMadjid AKROUR · contact · madjid.akrour@chu-st-etienne.fr · (0)4 77 12 78 37
All locations (8)
Infirmerie ProtestanteRecruiting
Caluire-et-Cuire, France
Chd VendeeRecruiting
La Roche-sur-Yon, France
Hopital PhilibertRecruiting
Lomme, France
Chu MontpellierRecruiting
Montpellier, France
Ap-Hp Pitie SalpetriereRecruiting
Paris, France
Chu ReimsNot Yet Recruiting
Reims, France
Chu Saint EtienneRecruiting
Saint-Etienne, France
Chru ToursNot Yet Recruiting
Tours, France