Actively Recruiting
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-12-26
180
Participants Needed
8
Research Sites
65 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Saint Etienne
Lead Sponsor
A
AAP MESSIDOR
Collaborating Sponsor
AI-Summary
What this Trial Is About
Rheumatoid arthritis (RA) is a common inflammatory joint disease. Researchers are studying an individualized strategy to reduce the dose of adalimumab, a biological drug, in patients who have achieved remission. The study aims to find the best adalimumab blood concentration to maintain before tapering treatment, as current guidelines for stepping down medication are unclear and flares may occur during tapering. Participants receive adalimumab injections combined with methotrexate and will be randomly assigned to one of three groups: a single-arm group following a clinical tapering strategy based on disease activity every three months, a maintenance group continuing the same adalimumab regimen, or an optimized tapering group where the timing of dose spacing depends on adalimumab trough blood levels. The tapering process and group assignment are randomized over 12 months. During the study, participants will be assessed every three months using disease activity scores to monitor flares. Researchers will track flare-ups over 15 months as the primary outcome, with infections as a secondary outcome. Participants' medication doses and health status will be regularly evaluated to guide tapering and ensure safety throughout the study period.
CONDITIONS
Brief Title
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years of age
- Diagnosis of rheumatoid arthritis according to ACR/EULAR 2010 criteria
- In remission with DAS28 score of 2.6 or less for at least 6 months
- Treated with adalimumab for at least 6 months with standard or extended dosing
- Negative highly sensitive pregnancy test for women of childbearing potential
- Affiliated with or beneficiary of a social security scheme
- Signed informed consent after receiving study information
You will not qualify if you...
- Unable or unwilling to understand and sign informed consent
- Pregnant, breastfeeding, or planning pregnancy within next 15 months
- Fibromyalgia associated with rheumatoid arthritis
- Use of any prednisone dose for rheumatoid arthritis in 6 months before inclusion
- Deprived of liberty or under guardianship or curatorship
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive adalimumab injections with dosing progressively spaced out based on clinical status and adalimumab trough concentration assessed every 3 months.
Visits every 3 months for dosing assessment and clinical evaluation
Trial Site Locations
Total: 8 locations
1
Infirmerie Protestante
Caluire-et-Cuire, France, 69300
Actively Recruiting
2
Chd Vendee
La Roche-sur-Yon, France, 85925
Actively Recruiting
3
Hopital Philibert
Lomme, France, 59160
Actively Recruiting
4
Chu Montpellier
Montpellier, France, 34295
Actively Recruiting
5
Ap-Hp Pitie Salpetriere
Paris, France, 75013
Actively Recruiting
6
Chu Reims
Reims, France, 51100
Not Yet Recruiting
7
Chu Saint Etienne
Saint-Etienne, France, 42055
Actively Recruiting
8
Chru Tours
Tours, France, 37170
Not Yet Recruiting
Research Team
H
Hubert MAROTTE, MD PhD
M
Madjid AKROUR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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