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Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2024-12-19
Completion Date
2027-12-19
Last Updated
2025-12-26
Healthy Volunteers
No
Conditions
Interventions
Clinical tapering strategy
Clinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months
Step 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
Locations (8)
Infirmerie Protestante
Caluire-et-Cuire, France
Chd Vendee
La Roche-sur-Yon, France
Hopital Philibert
Lomme, France
Chu Montpellier
Montpellier, France
Ap-Hp Pitie Salpetriere
Paris, France
Chu Reims
Reims, France
Chu Saint Etienne
Saint-Etienne, France
Chru Tours
Tours, France