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
156 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 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
Official 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
- Remission with DAS28 score of 2.6 or less for at least 6 months
- Treated with adalimumab for at least 6 months, either 40 mg every 14 days or every 21 days
- Negative highly sensitive pregnancy test for women who can become pregnant
- 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 or sign informed consent
- Current pregnancy, breastfeeding, or planning pregnancy within 15 months
- Fibromyalgia associated with rheumatoid arthritis
- Any prednisone use for RA treatment within 6 months before joining
- Deprived of liberty or under guardianship or curatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
M
Madjid AKROUR
CONTACT
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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