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Studies

Observational Recruiting

NCT07348263 on ClinicalTrials.gov

EFESO: Study on Juvenile Onset Eosinophilic Fasciitis

Official title: International Multicentre Cohort Study on Clinical Manifestations and Response to Therapy in Juvenile Onset Eosinophilic Fasciitis

  • Sponsor: Meyer Children's Hospital (Italy)
  • Enrollment: 20 (Estimated)
  • Study start: 2025-05-15 (Actual)
  • Primary completion: 2026-05-15 (Estimated)
  • Study completion: 2027-05-15 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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.

Conditions

  • Eosinophilic Fasciitis

Primary Outcome Measures

  • Clinical and laboratory features (2025-2027)
    Describe the clinical and laboratory features at presentation and during follow-up, including the extent of skin involvement and extracutaneous manifestations, of patients diagnosed with JEF.

Countries

Croatia, Germany, Israel, Italy, Romania, Slovenia, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States

Locations and Investigators

  • University of Alabama at Birmingham, Birmingham, United States (Recruiting)
  • SUNY Upstate Pediatric Rheumatology, Syracuse, United States (Recruiting)
  • Children's Hospital Zagreb, Zagreb, Croatia (Recruiting)
  • Hamburger Zentrum für Kinder- und Jugendrheumatologie -, Hamburg, Germany (Not yet recruiting)
  • Ruth Rappaport Children's Hospital of Haifa, Haifa, Israel (Not yet recruiting)
  • Meyer Children's Hospital IRCCS, Florence, Italy (Recruiting)
  • IRCCS Giannina Gaslini,, Genova, Italy (Recruiting)
    • Riccardo Papa
  • Università di Udine, Udine, Italy (Not yet recruiting)
    • Giorgia Martini
  • Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania (Recruiting)
  • University Children's Hospital, Ljubljana, Slovenia (Not yet recruiting)
    • Natasa Toplak
  • Hospital Sant Joan de Déu,, Barcelona, Spain (Not yet recruiting)
    • Joan Calzada Hernández
  • Astrid Lindgren Children's Hospital, Solna, Sweden (Recruiting)
  • Cerrahpasa Medical School, Istanbul University, Istanbul, Turkey (Türkiye) (Not yet recruiting)
  • Alder Hey Children's Hospital, Liverpool, United Kingdom (Recruiting)
    • Clare Pain
  • Great North Children's Hospital, Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom (Not yet recruiting)
    • Miguel Bernardo