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

NCT06528431 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-12-26

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • AAP MESSIDOR

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06528431 on ClinicalTrials.gov