RChildUV:Study on Non-infectious Chronic Uveitis in Pediatric Age
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: Uveitis. Basic parameters: 1 year — 16 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, Belgium, Greece, Italy, Turkey (Türkiye)
- 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
Retrospective and Prospective Observational Study on Non-infectious Chronic Uveitis in Pediatric Age
Overview
Uveitis is an inflammatory disease of the uvea, one of the highly vascularized fundamental structures of the eye. It is a rare condition in children, with an incidence in the pediatric population ranging from 2% to 14% of all uveitis cases. The diagnosis and management of patients with uveitis rely on a multidisciplinary approach involving an ophthalmologist, a rheumatologist, and an infectious disease specialist to establish the correct diagnosis and assess the involvement of other organs. In Italy, there is no national or regional registry for non-infectious chronic uveitis as per the Prime Ministerial Decree (DPCM) of March 3, 2017 (Identification of surveillance systems and registries for mortality, tumors, and other diseases). However, many clinical centers adopt data recording systems to evaluate the quality of care and to study diseases and outcomes. The Universitary Hospital Meyer Institute Research Hospital (IRCCS) is a national referral center for managing these pediatric cases of non-infectious chronic uveitis, estimated to constitute 95% of all pediatric uveitis cases
Primary outcome measures
- Describe a population of paediatric patients with chronic non-infectious uveitis [Time frame: thorugh the study and after 1 year]
- Describe a population of paediatric patients with chronic non-infectious uveitis [Time frame: 6 months, 12 months, 2 years and then every year]
- Identify any differences between the different forms of uveitis in terms of characteristics and outcomes [Time frame: thorugh the study and after 1 year]
- Identify risk factors for a more severe course [Time frame: thorugh the study and after 1 year]
- Frequency achievement of response for each drug according to the definition of response [Time frame: thorugh the study and after 1 year]
- Time to archieve the response after drug initiation [Time frame: thorugh the study and after 1 year]
- Achievement of inactive disease on therapy according to the definition of MIWGUC [Time frame: thorugh the study and after 1 year]
- Time to achieve inactive disease on therapy according to the definition of MIWGUC [Time frame: thorugh the study and after 1 year]
- Presence and percentages of flares on therapy after achievement of remission on therapy [Time frame: thorugh the study and after 1 year]
- Time to the first flare on therapy [Time frame: thorugh the study and after 1 year]
Eligibility criteria
Inclusion criteria
- diagnosis of non-infectious chronic uveitis before the age of 16;
- signed informed consent form.
Exclusion criteria
- Patients with a diagnosis of infectious uveitis
- history of malignant pathology,
- history of demyelinating pathology,
- history of cerebral vasculitis
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 · 13 centers
- Meyer Children's Hospital IRCCS — Florence
- Department of Pediatrics, Giovanni XXIII Pediatric Hospital, University of Bari — Bari
- Ospedale Spedali Civili di Brescia — Brescia
- Department of Medical of Health Sciences, Magna Grecia University — Catanzaro
- Dipartimento di Immunologia e Reumatologia Pediatrica, Ospedale Vito Fazzi — Lecce
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico SC Pediatria e Immunoreumatologi — Milan
- Unità di Reumatologia ed Immunologia Pediatrica dell'Ospedale Fatebenefratelli Sacco di Mi — Milan
- - UOSD Reumatologia Pediatrica Dipartimento di Salute della Donna e del Bambino Azienda Os — Padova
- … and 5 more centers
United States · 3 centers
- Children's Mercy Kansas City Division of Rheumatology, Division of Rheumatology — Kansas City
- The Children's Hospital Corporation d/b/a Boston Children's Hospital — Boston
- Cincinnati Children's Hospital Medical Center — Cincinnati
Belgium · 1 center
- University fo Gent — Ghent
Greece · 1 center
- ATTIKON General Hospital — Athens
Turkey (Türkiye) · 1 center
- Department of Pediatric Rheumatology, Kocaeli University, — Kocaeli
Identifiers
NCT: NCT06273748 · RChildUV