Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study

Last updated: May 15, 2025
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Active - Recruiting

Phase

4

Condition

Rheumatoid Arthritis

Joint Injuries

Treatment

Clinical tapering strategy

Step Wedge trial

Clinical Study ID

NCT06528431
24CH046
2024-514313-35-00
  • Ages > 18
  • All Genders

Study 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

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 toone 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

Exclusion Criteria:

  • Incapacity or refusal to understand and / or sign informed consent to participate inthe 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.

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Clinical tapering strategy
Phase: 4
Study Start date:
December 19, 2024
Estimated Completion Date:
December 19, 2026

Connect with a study center

  • Infirmerie Protestante

    Caluire-et-Cuire, 69300
    France

    Site Not Available

  • Chd Vendee

    La Roche-sur-Yon, 85925
    France

    Site Not Available

  • Hopital Philibert

    Lomme, 59160
    France

    Site Not Available

  • Chu Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • Ap-Hp Pitie Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Chu Reims

    Reims, 51100
    France

    Site Not Available

  • Chu Saint Etienne

    Saint-Étienne, 42055
    France

    Active - Recruiting

  • Chru Tours

    Tours, 37170
    France

    Site Not Available

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