NCT06019221

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2024

Completed
Last Updated

November 2, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 24, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

PolychondritisRelapsing PolychondritisPediatric Relapsing Polychondritis

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Minor subject aged 1 to 17 years having atrophic polychondritis

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Polychondritis, Relapsing

Condition Hierarchy (Ancestors)

Cartilage DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ariane ZALOSZYC, MD

    University Hospitals of Strasbourg

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 31, 2023

Study Start

February 18, 2023

Primary Completion

January 18, 2024

Study Completion

January 18, 2024

Last Updated

November 2, 2023

Record last verified: 2023-08

Locations