Observational cohort for Adult Onset Still Disease and Systemic onset Juvenile Idiopathic Arthritis

Cohorte d'Adultes et d'Enfants Avec Maladie de Still

This study is collecting information from adults and children with Adult Onset Still Disease and Systemic onset Juvenile Idiopathic Arthritis to better understand their symptoms and how the diseases progress.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (other gov)
• Drugs / interventions: methotrexate
• Locations: 1 site (Paris, Île-de-France Region)
• Trial ID: NCT05927454 on ClinicalTrials.gov

What this trial studies

This observational cohort study focuses on Adult Onset Still Disease (AOSD) and Systemic onset Juvenile Idiopathic Arthritis (SoJIA), two rare inflammatory diseases that share similar symptoms and diagnostic criteria. The study aims to collect clinical and biological data from affected patients to better understand the disease's characteristics and progression. Participants will be monitored for symptoms such as fever, arthritis, and skin rash, and their inflammatory markers will be analyzed. The study will include both adults and children diagnosed with these conditions, providing valuable insights into their management and treatment.

Who should consider this trial

Good fit: Ideal candidates include individuals over 16 years old diagnosed with AOSD or children under 16 with SoJIA.

Not a fit: Patients with other causes of relapsing infectious fever or defined inflammatory rheumatism may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and prognostic markers for patients with Still Disease.

How similar studies have performed: While there is limited data on similar cohort studies, the rarity of these diseases suggests that this approach may provide novel insights.

Eligibility criteria

Inclusion Criteria:

* Aged over 16 (age\> 16) meeting the diagnostic criteria of Yamaguchi or Fautrel criteria (appendix 5)
* Aged 16 years or less (age ≤16 years) fulfilling the 2001 criteria for ILAR systemic form of juvenile idiopathic arthritis
* Having signed a consent to participate in the cohort and in the collection of clinical and biological data; in accordance with the regulations, for patients who are minors or adults who are protected, the non-opposition of the legal representatives will be sought.
* Affiliated to the "Régime National d'Assurance Maladie".

Exclusion Criteria:

* Other cause of relapsing infectious fever (such as tuberculosis, toxoplasmosis, deep abscesses, viroses, sepsis) or tumor (such as lymphomas)
* Other defined inflammatory rheumatism such as rheumatoid arthritis, psoriatic arthritis, spondyloarthropathies.
* Autoimmune inflammatory disease (systemic lupus erythematosus), granulomatosis (sarcoidosis, Blau syndrome), vasculitis (Behçet's disease, nodular arteritis), polymyositis and dermatomyositis.
* Well-defined auto-inflammatory syndromes with unambiguous mutations, such as familial Mediterranean fever, cryopyrinopathies, TRAPS, mevalonate kinase deficiency.
* Known macrophage activation syndromes of genetic origin.
* Patients unable to understand the information leaflet and sign the informed consent form
* Patients not affiliated to the "Régime National d'Assurance Maladie"

Where this trial is running

Paris, Île-de-France Region

• RaDiCo-AcoStill — Paris, Île-de-France Region, France (RECRUITING)

Study contacts

• Principal investigator: Sophie Georgin-Lavialle, PHD — INSERM U933
• Study coordinator: Sophie Georgin-Lavialle, PHD

Conditions: Still Disease, Still's Disease, Adult-Onset, Still Disease, Juvenile Onset, Rare disease, Diagnostic markers, Prognostic markers, New therapies