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NCT06528431 | NOT YET RECRUITING | Arthritis, Rheumatoid

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

Saint Etienne University Hospital Center

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.

Condition or disease

Arthritis, Rheumatoid

Intervention/treatment

Clinical tapering strategy

Step Wedge trial

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2025-03
Estimated Study Completion Date : 2026-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
  • * Patients with ongoing adalimumab treatment (40 mg every other week) according to the standard regimen for at least 6 months
  • * 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
  • * A failure of previous tapering
  • * Any dose of prednisone for RA treatment 6 months before inclusion
  • * Patient deprived of liberty or patient under guardianship or curator ship.
Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study

Location Details

NCT06528431

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Protestant Infirmary

Caluire-et-Cuire, France, 69300

Not yet recruiting

France,

Chd Vendee

La Roche-sur-Yon, France, 85925

Not yet recruiting

France,

Hopital Philibert

Pocket, France, 59160

Not yet recruiting

France,

Chu Montpellier

Montpellier, France, 34295

Not yet recruiting

France,

Ap-Hp Drinking Salpetriere

Paris, France, 75013

Not yet recruiting

France,

Chu Saint ATN

Saint-Étienne, France, 42055