Status:
RECRUITING
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
AAP MESSIDOR
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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, remissio...
Eligibility Criteria
Inclusion
- 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
- Patient treated with ADA for at least 6 months. The patient is treated according to one of the following two strategies:
- ADA 40 mg every two weeks (= every 14 days) according to the standard regimen
- or ADA 40 mg every 3 weeks (= every 21 days)
- A negative highly sensitive pregnancy test for women of Childbearing Potential\*
- Affiliated person or beneficiary of a social security scheme
- Informed consent signed by the patient after information
Exclusion
- 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
- Patient deprived of liberty or patient under guardianship or curator ship.
Key Trial Info
Start Date :
December 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 19 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06528431
Start Date
December 19 2024
End Date
December 19 2027
Last Update
December 26 2025
Active Locations (8)
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1
Infirmerie Protestante
Caluire-et-Cuire, France, 69300
2
Chd Vendee
La Roche-sur-Yon, France, 85925
3
Hopital Philibert
Lomme, France, 59160
4
Chu Montpellier
Montpellier, France, 34295