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

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ClinicalTrials.gov Identifier: NCT06019221
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : November 2, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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
Relapsing Polychondritis

Study Design
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Study Type : Observational
Estimated 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 : February 18, 2023
Estimated Primary Completion Date : January 18, 2024
Estimated Study Completion Date : January 18, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Therapeutic effectiveness of the various treatments proposed depending on the degree of initial clinical involvement [ Time Frame: 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
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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Minor subject aged 1 to 17 years having atrophic polychondritis
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06019221


Contacts
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Contact: Ariane ZALOSZYC, MD 33 3 88 12 77 42 ariane.zaloszyc@chru-strasbourg.fr
Contact: Sarah-Louisa MAHI, MD 33 3 88 12 77 42 sarah-louisa.mahi@chru-strasbourg.fr

Locations
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France
Service de Pédiatrie 1 - CHU de Strasbourg - France Recruiting
Strasbourg, France, 67091
Contact: Ariane ZALOSZYC, MD    33 3 88 12 77 42    ariane.zaloszyc@chru-strasbourg.fr   
Contact: Sarah-Louisa MAHI, MD    33 3 88 12 77 42    sarah-louisa.mahi@chru-strasbourg.fr   
Principal Investigator: Ariane ZALOSZYC, MD         
Sub-Investigator: Sarah-Louisa MAHI, MD         
Sub-Investigator: Alexandre BELOT, MD         
Sub-Investigator: Johanna CLET, MD         
Sub-Investigator: Yves HATCHUEL, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Study Director: Ariane ZALOSZYC, MD University Hospitals of Strasbourg
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT06019221    
Other Study ID Numbers: 8783
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: November 2, 2023
Last Verified: August 2023

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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:
Polychondritis
Relapsing Polychondritis
Pediatric Relapsing Polychondritis
Additional relevant MeSH terms:
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Polychondritis, Relapsing
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases