Adult Outcomes of Children With CAPS

Cryopyrin Associated Periodic Syndrome Clinical Trial

— CAPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856540
• Other study ID #: 2021/0105
• Secondary ID: 2021-A00585-36
• Status: Completed
• Start date: September 16, 2021
• Est. completion date: February 25, 2022

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 25, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryopyrin Associated Periodic Syndrome
• Cryopyrin-Associated Periodic Syndromes
• Syndrome

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical characteristics of patients with CAPS in adulthood		Baseline
Secondary	Assessment of the quality of life of patients with CAPS in adulthood		Baseline
Secondary	Compare the clinical status between childhood and adulthood		Baseline
Secondary	Compare the clinical status of patients according to their genetic variant.		Baseline