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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

Qualifiers

Patient over 18 years of age

Patients with a diagnosis of RA according to ACR/EULAR 2010 criteria

Remission according to DAS28<=2.6 for at least 6 months

ADA 40 mg every two weeks (= every 14 days) according to the standard regimen

Disqualifiers

Incapacity or refusal to understand and / or sign informed consent to participate in the study.

Existing pregnancy, lactation, or intended pregnancy within the next 15 months

Fibromyalgia associated to RA

Any dose of prednisone for RA treatment 6 months before inclusion

Trial design

Treatments tested in this trial

  • Clinical tapering strategy
  • Step Wedge trial

Treatment groups

180 Participants
are divided into 3 treatment groups

Sponsors and collaborators