Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Infirmerie Protestante
NOT_YET_RECRUITING
Caluire-et-cuire
Chd Vendee
NOT_YET_RECRUITING
La Roche-sur-yon
Hopital Philibert
NOT_YET_RECRUITING
Lomme
Chu Montpellier
NOT_YET_RECRUITING
Montpellier
Ap-Hp Pitie Salpetriere
NOT_YET_RECRUITING
Paris
Chu Reims
NOT_YET_RECRUITING
Reims
Chu Saint Etienne
RECRUITING
Saint-etienne
Chru Tours
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Hubert MAROTTE, MD PhD
hubert.marotte@chu-st-etienne.fr
(0)4 77 12 76 49
Backup
Florence RANCON
florence.rancon@chu-st-etienne.fr
(0)4 77 82 94 58
Time Frame
Start Date:2024-12-19
Estimated Completion Date:2026-12-19
Participants
Target number of participants:180
Treatments
Experimental: Single arm trial
Single arm trial in patients with established RA who achieved clinical remission with subcutaneous injection of adalimumab in combination with MTX (methotrexate). Patients will undergo a tapering strategy based only on the clinical status (flare /no flare) during 12 months.
No_intervention: Maintenance arm
Maintenance arm: the same adalimumab regimen
Experimental: Optimized tapering adalimumab
An optimized tapering adalimumab strategy based on the disease activity and the adalimumab trough concentration. The tapering strategy will rely on the adalimumab trough concentration. Spacing will be performed only if adalimumab trough concentration is above the pre-specified concentration threshold