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

PHASE4RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

December 19, 2024

Primary Completion Date

September 19, 2025

Study Completion Date

December 19, 2026

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

Clinical tapering strategy

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

DRUG

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

Trial Locations (8)

34295

NOT_YET_RECRUITING

Chu Montpellier, Montpellier

37170

NOT_YET_RECRUITING

Chru Tours, Tours

42055

RECRUITING

Chu Saint Etienne, Saint-Etienne

51100

NOT_YET_RECRUITING

Chu Reims, Reims

59160

NOT_YET_RECRUITING

Hopital Philibert, Lomme

69300

NOT_YET_RECRUITING

Infirmerie Protestante, Caluire-et-Cuire

75013

NOT_YET_RECRUITING

Ap-Hp Pitie Salpetriere, Paris

85925

NOT_YET_RECRUITING

Chd Vendee, La Roche-sur-Yon

All Listed Sponsors
collaborator

AAP MESSIDOR

UNKNOWN

lead

Centre Hospitalier Universitaire de Saint Etienne

OTHER

NCT06528431 - Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study | Biotech Hunter | Biotech Hunter