drugset / Trial / NCT06528431

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

NCT06528431

RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-19
Primary completion
2026-09-19
Completion
2027-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody Subcutaneous

Indications