NCT04856540

Completed

Adult Outcomes of Children With CAPS

University Hospital, Lille Source

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Other study identifiers

Sponsor study identifier

2021/0105

Secondary identifiers

2021-A00585-36

OTHER · ID-RCB number,ANSM

Study Type

observational

Actual enrollment (reported)

54

Locations

1 country

Sites

1

Timeline

Study Start

September 16, 2021

Actual (reported)

Primary Completion

February 25, 2022

Actual (reported)

Study Completion

February 25, 2022

Actual (reported)

Brief 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 54 participants
Study completion date: February 25, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 13, 2021
Actual (reported)
First Posted
April 23, 2021
Actual (reported)
Study Start
September 16, 2021
Actual (reported)
Primary Completion
February 25, 2022
Actual (reported)
Study Completion
February 25, 2022
Actual (reported)

Last Updated: January 18, 2023
Status Verified: January 2023
Last Update Submitted: January 17, 2023

Conditions

Cryopyrin Associated Periodic Syndrome

Keywords

CAPS Cryopyrin associated periodic syndromesMWS Muckle-Wells syndromeCINCA Chronic infantile neurological cutaneous and articular syndrome ;FCAS Familial cold auto-inflammatory syndromePhenotype ; Quality of lifeQuality of life

Outcome Measures

Primary Outcomes (1)

Clinical characteristics of patients with CAPS in adulthood
Baseline

Secondary Outcomes (3)

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

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

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

You may qualify if:

Diagnosis of FCAS, Muckle-Wells or NOMID/CINCA;

Sponsors & Collaborators

University Hospital, Lille
Otherlead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

MeSH Terms

Conditions

Cryopyrin-Associated Periodic Syndromes

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesChronic Inducible UrticariaChronic UrticariaUrticariaSkin Diseases, VascularCold UrticariaHypersensitivity, ImmediateHypersensitivity

Study Officials

Eric Hachulla, MD,PhD
University Hospital, Lille
PRINCIPAL INVESTIGATOR

Enrollment

54 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 23, 2021

Study Start

September 16, 2021

Actual (reported)

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Phase 1Completed

age \< 16 years at the apparition of the first symptoms of the disease;

follow-up in a CEREMAIA reference or competence center.

You may not qualify if:

non-consenting patient

Contact the study team to confirm eligibility.

Immune System Diseases

Chronic Disease

Disease Attributes

Pathologic Processes

Pathological Conditions, Signs and Symptoms

Primary Completion

February 25, 2022

Actual (reported)

Study Completion

February 25, 2022

Actual (reported)

Last Updated

January 18, 2023

Record last verified: 2023-01

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT04856540
Data provider: ClinicalTrials.gov
Source updated: 2023-01-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:45 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations