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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04856540
Other study ID # 2021/0105
Secondary ID 2021-A00585-36
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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Completed NCT05186051 - A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects With Cryopyrin Associated Periodic Syndromes (CAPS) Phase 2
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