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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
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

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Clinique de l'infirmerie Protestante
Coordinator of this site? Confirm its status
Caluire-et-CuireFranceRecruiting
Centre Hospitalier Regional Universitaire De Tours
Coordinator of this site? Confirm its status
Chambray Les ToursFranceRecruiting
Centre Hospitalier Departemental Vendee
Coordinator of this site? Confirm its status
La Roche Sur Yon Cedex 9FranceRecruiting
Groupement Des Hopitaux De L'Institut Catholique De Lille
Coordinator of this site? Confirm its status
Lomme CedexFranceRecruiting
Centre Hospitalier Universitaire De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceRecruiting
Hopitaux Universitaires Pitie Salpetriere
Coordinator of this site? Confirm its status
Paris Cedex 13FranceRecruiting
Centre Hospitalier Universitaire Reims
Coordinator of this site? Confirm its status
Reims CedexFranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
Coordinator of this site? Confirm its status
Saint-Priest-en-JarezFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.