Individualized tapering strategy for rheumatoid arthritis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a personalized tapering strategy for patients with rheumatoid arthritis who have achieved remission while being treated with adalimumab. It aims to determine the optimal blood concentration of adalimumab before initiating a tapering process to minimize the risk of disease flares. The approach utilizes a step wedge trial design to assess the effectiveness of this individualized strategy in managing treatment. By understanding the best tapering practices, the study seeks to provide clearer guidelines for clinicians.

Why it matters

Who can join: the full rules

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.

Where it's running

• Infirmerie Protestante
  Caluire-et-Cuire, France Recruiting
• Chd Vendee
  La Roche-sur-Yon, France Recruiting
• Hopital Philibert
  Lomme, France Recruiting
• Chu Montpellier
  Montpellier, France Recruiting
• Ap-Hp Pitie Salpetriere
  Paris, France Recruiting
• Chu Saint Etienne
  Saint-Etienne, France Recruiting

Study contacts

• Study coordinator: Hubert MAROTTE, MD PhD
• Email: hubert.marotte@chu-st-etienne.fr
• Phone: (0)4 77 12 76 49

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.