NCT06528431RecruitingPhase 4
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 19 Jul 2024
- Start date
- 19 Dec 2024
- Primary completion date
- 19 Sept 2026
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06528431
- EU CT number
- 2024-514313-35-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 180
- From 19 Dec 2024 to the primary completion date, 19 Sept 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any dose of prednisone for RA treatment 6 months before inclusion
Other
- 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
- Patient deprived of liberty or patient under guardianship or curator ship.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique de l'infirmerie Protestante Coordinator of this site? Confirm its status | Caluire-et-Cuire | France | Recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Chambray Les Tours | France | Recruiting |
| Centre Hospitalier Departemental Vendee Coordinator of this site? Confirm its status | La Roche Sur Yon Cedex 9 | France | Recruiting |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lomme Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Hopitaux Universitaires Pitie Salpetriere Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.