Clinical trial NCT06528431: Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Official title: Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis, Rheumatoid
Adalimumab
Remission management
step wedge trial
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: AAP MESSIDOR
First posted: 2024-07-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomization comparing 2 therapeutic strategies
Primary purpose: TREATMENT

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, 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: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Rheumatoid arthritis flare-up
timeFrame: 15 Months
Secondary outcomes:
measure: Infection
timeFrame: 15 months
Other outcomes:
Locations:
city: Caluire-et-Cuire
country: France
facility: Infirmerie Protestante
city: La Roche-sur-Yon
country: France
facility: Chd Vendee
city: Lomme
country: France
facility: Hopital Philibert
city: Montpellier
country: France
facility: Chu Montpellier
city: Paris
country: France
facility: Ap-Hp Pitie Salpetriere
city: Reims
country: France
facility: Chu Reims
city: Saint-Étienne
country: France
facility: Chu Saint Etienne
city: Tours
country: France
facility: Chru Tours
Study officials:
References: