RecruitingPhase 4NCT06528431

Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

180 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

Arthritis, Rheumatoid

Summary

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

Min Age: 18 Years

Inclusion Criteria9

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 Criteria5

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.

Interventions

DRUGClinical tapering strategy

Clinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months

DRUGStep Wedge trial

Step Wedge trial : At baseline, all the patients will receive in this study the standard adalimumab dosing regimen. At subsequent time points (steps), patients will begin the intervention of interest, here the tapering adalimumab strategy. The time at which a patient begins the intervention will be randomized. We fixed the time steps duration to 3 months that corresponds the frequency of there commended follow-up of RA patients