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

Relapsing Polychondritis Clinical Trial

— PRP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019221
• Other study ID #: 8783
• Status: Recruiting
• Start date: February 18, 2023
• Est. completion date: January 18, 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Ariane ZALOSZYC, MD
• Phone: 33 3 88 12 77 42
• Email: ariane.zaloszyc[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 18, 2024
• Est. primary completion date: January 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Relapsing Polychondritis

Locations

Country	Name	City	State
France	Service de Pédiatrie 1 - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic effectiveness of the various treatments proposed depending on the degree of initial clinical involvement	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.	Files analysed retrospectively from from January 01, 2008 to December 31, 2022 will be examined