Clinical Trial

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

Study acronym: MONITORA
Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-07-25; most recent amendment 2025-12-19.
Status change: Not Yet Recruiting → Recruiting 2025-01-15
Trial Details
NCT Number NCT06528431
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborators: AAP MESSIDOR
Conditions Arthritis, Rheumatoid
Enrollment 180 participants
Start Date 2024-12-19
Primary Completion 2026-09-19 (estimated)
Study Completion 2027-12-19 (estimated)
Updated on ClinicalTrials.gov 2025-12-26