Self-management app to help people with inflammatory arthritis stay safe

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 interventional study tests a self-management mobile app designed for adults with inflammatory arthritis who are starting a targeted DMARD or biologic. The app aims to support treatment adherence, safety planning, and information needs to reduce infection risks and other adverse events. Eligible participants are 18 to 75 years old, have RA, axial or peripheral SpA, or PsA, and are starting a new tDMARD, bDMARD, or JAK inhibitor. The study evaluates whether use of the app improves safety skills and engagement compared with standard care. Recruitment is centered at a rheumatology center in Paris, with participants required to have smartphone access and the ability to use a website and complete questionnaires.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 18 and 75 years
* Diagnosis of rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria of the American College of Rheumatology, or axial or peripheral spondyloarthritis (SpA) according to the 2009 ASAS criteria of the Assessment of SpondyloArthritis International Society, or psoriatic arthritis according to the 2009 CASPAR criteria.
* Undergoing a treatment change to a tDMARD (biologic or JAK inhibitor) available in the SFR application.
* No therapeutic education on tDMARDs in the past two years.
* Ability to use a smartphone application.
* Ability to use a website.
* Ability to complete a questionnaire.
* Signed informed consent for the study.
* Covered by social security or entitled to social protection.

Exclusion Criteria:

* Any condition that may affect comprehension or treatment adherence (chronic alcoholism, language barrier, severe psychiatric disorders, cognitive impairment).
* Planned treatment with intravenous bDMARDs in the upcoming year.
* Patients who have already downloaded self-management applications for their rheumatic disease.
* Patients enrolled in a therapeutic education program: face-to-face education by a nurse or healthcare professional, or group education.
* Patients who have already received therapeutic education on targeted DMARDs in the past two years: face-to-face education by a nurse or healthcare professional, or group education.
* Participation in another interventional clinical trial
* Pregnant or breast-feeding woman
* Individual under legal protection (tutorship or guardianship) or deprived of freedom

Where it's running

• Rheumatology Hopital Saint Antoine
  Paris, France Recruiting

Study contacts

• Principal investigator: Catherine BEAUVAIS, Medical Doctor — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Catherine BEAUVAIS, Medical Doctor
• Email: catherine.beauvais@aphp.fr
• Phone: +33149282520

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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.