EFESO: Study on Juvenile Onset Eosinophilic Fasciitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Eosinophilic Fasciitis. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Croatia, Germany, Israel, Italy +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
International Multicentre Cohort Study on Clinical Manifestations and Response to Therapy in Juvenile Onset Eosinophilic Fasciitis
Overview
Eosinophilic fasciitis is a connective tissue disorder characterized by inflammation of the muscle fasciae, which is very rare in children. In juvenile-onset eosinophilic fasciitis (JEF), there may be severe joint involvement and skin manifestations may be less prevalent than in adults. It represents an important differential diagnosis of both juvenile-onset systemic sclerosis and localized scleroderma, and the correct classification of these patients is necessary to define a targeted diagnostic-therapeutic pathway. The diagnostic criteria proposed for eosinophilic fasciitis in the adult population do not necessarily require confirmation by skin biopsy, currently the "gold standard," which is an invasive procedure for pediatric patients; however, these criteria have never been directly applied to the pediatric population. From a therapeutic point of view, the combination of glucocorticoids and methotrexate is recommended for both adults and pediatric patients, but the data supporting this treatment in children are very limited, and there are no studies comparing the therapeutic approaches currently in use in pediatrics. Finally, there are no studies in the literature documenting the long-term prognosis of these patients in terms of functional limitations, quality of life, or complications related to the disease or treatments.
Primary outcome measures
- Clinical and laboratory features [Time frame: 2025-2027]
Eligibility criteria
Inclusion criterai:
All patients diagnosed from 2000 to 31/12/2026
- minimum follow-up 6 months
- Age <18 years at diagnosis;
- All patients whose informed consent is collected in accordance with current local legislation will also be considered enrollable.
Exclusion criteria
- Age ≥18 years at diagnosis;
- Unwilling to participate into the study;
- A follow-up period < 6 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 3 centers
- Meyer Children's Hospital IRCCS — Florence
- IRCCS Giannina Gaslini, — Genova
- Università di Udine — Udine
United States · 2 centers
- University of Alabama at Birmingham — Birmingham
- SUNY Upstate Pediatric Rheumatology — Syracuse
United Kingdom · 2 centers
- Alder Hey Children's Hospital — Liverpool
- Great North Children's Hospital, Newcastle Upon Tyne — Newcastle upon Tyne
Croatia · 1 center
- Children's Hospital Zagreb — Zagreb
Germany · 1 center
- Hamburger Zentrum für Kinder- und Jugendrheumatologie - — Hamburg
Israel · 1 center
- Ruth Rappaport Children's Hospital of Haifa — Haifa
Romania · 1 center
- Iuliu Hatieganu University of Medicine and Pharmacy — Cluj-Napoca
Slovenia · 1 center
- University Children's Hospital — Ljubljana
Spain · 1 center
- Hospital Sant Joan de Déu, — Barcelona
Sweden · 1 center
- Astrid Lindgren Children's Hospital — Solna
Turkey (Türkiye) · 1 center
- Cerrahpasa Medical School, Istanbul University — Istanbul
Identifiers
NCT: NCT07348263 · EFESO