PRP: Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT06019221
Collaborator
(none)
20
1
11
1.8

Study Details

Study Description

Brief Summary

The incidence in pediatrics is very low (about 3.5 per million per year according to a 2015 study) and therefore the data on the pathology very poor, especially on the therapeutic level.

Without appropriate treatment, the disabling sequelae, even involving the vital prognosis, are significant. However, in paediatrics, therapeutic habits have been extrapolated from adult data and lack precision.

Existing treatments are almost composed of immunomodulatory and/or immunosuppressive treatments. Different therapeutic lines have been introduced over the years and a better understanding of the pathology. More recently, biotherapies have been introduced in this pathology, but data on their effectiveness remain limited. Data on the evolution under therapy in children are thus still poor.

Complications related to the pathology that can jeopardize the vital prognosis and the response to treatment for this pathology deserve to be studied in order to be known and if possible avoided.

The aim of the study is to describe French practices and compare the lines of treatment proposed for juvenile atrophic polychondritis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Pediatric Relapsing Polychondritis : Diagnosis and Management in a French Retrospective Study
    Actual Study Start Date :
    Feb 18, 2023
    Anticipated Primary Completion Date :
    Jan 18, 2024
    Anticipated Study Completion Date :
    Jan 18, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Description of the various treatments for pediatric relapsing polychondritis in France [Files analysed retrospectively from from January 01, 2008 to December 31, 2022 will be examined]

      The aim of this study is to bring together the experiences of the various reference and competence centers in France concerning the clinical presentation, management and follow-up of children with relapsing polychondritis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Minor subject aged 1 to 17 years

    • Diagnosis of atrophic polychondritis between 01/01/2008 to 31/12/2022.

    • Subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

    Exclusion criteria:
    • Subject (or his parents) having expressed his (their) opposition to participating in the study

    • Associated pathologies that cannot be related to the diagnosis of atrophic polychondritis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Pédiatrie 1 - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Study Director: Ariane ZALOSZYC, MD, University Hospitals of Strasbourg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT06019221
    Other Study ID Numbers:
    • 8783
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Aug 31, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 31, 2023