Adult Outcomes of Children With CAPS (CAPS)

January 17, 2023 updated by: University Hospital, Lille

Clinical Characteristic and Quality of Life Assessment in Adulthood of Patients With Cryopyrin Associated Periodic Syndrome

The patients included in this study were followed up in the Internal Medicine and Paediatrics Departments of the Lille CHU, the Paediatric Rheumatology and Immunology Department of the Necker Enfant Malade Hospital in Paris and the Paediatric Rheumatology Department and Internal Medicine of the Bicêtre Hospital in Paris. All patients selected presented one of the 3 CAPS clinical phenotypes (CINCA/NOMID, Muckle-Wells or Cold Urticaria). The mutation and the determination of the variant had to be confirmed by genetic analysis.

Patient data were collected from their medical records, retrospectively. Data collected concern childhood period from appearance of symptoms, adulthood period, in the last year and patients' way of life and quality of life upon the assessment. In addition, we collected demographic data related to the patients' lifestyle (intoxications, living arrangements, level of education) and we conducted individual telephone interviews lasting 15 minutes to complete a quality of life questionnaire including the SF36 questionnaire.

The study aimed to describe the clinical symptoms of patients in adulthood and to assess quality of life. We also wanted to compare the clinical phenotypes of patients according to their genetic variant.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hop Claude Huriez Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients follow-up in a CEREMAIA reference or competence center.

Description

Inclusion Criteria:

  • Diagnosis of FCAS, Muckle-Wells or NOMID/CINCA;
  • age < 16 years at the apparition of the first symptoms of the disease;
  • age ≥ 16 years old at inclusion
  • follow-up in a CEREMAIA reference or competence center.

Exclusion Criteria:

  • Age < 16 years at inclusion;
  • non-consenting patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical characteristics of patients with CAPS in adulthood
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the quality of life of patients with CAPS in adulthood
Time Frame: Baseline
Baseline
Compare the clinical status between childhood and adulthood
Time Frame: Baseline
Baseline
Compare the clinical status of patients according to their genetic variant.
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Eric Hachulla, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2021

Primary Completion (Actual)

February 25, 2022

Study Completion (Actual)

February 25, 2022

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/0105
  • 2021-A00585-36 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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