NCT02811705

Brief Summary

This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve their overall care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

June 15, 2016

Last Update Submit

February 6, 2023

Conditions

PFAPA Syndrome

Outcome Measures

Primary Outcomes (1)

  • Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves

    1 day

Secondary Outcomes (1)

  • Evaluate the fatigue status of patients through questionnaire PedsQL TM 3.0 multidimensional scale tiredness

    1 day

Study Arms (2)

PFAPA group

Life quality for PFAPA patient report by themselves or parent

Other: Quality of life

FMF group

Life quality for FMF patient report by themselves or parent

Other: Quality of life

Interventions

Quality of lifeOTHER

Quality of life

FMF groupPFAPA group

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with PFAPA syndrome compare to patient with FMF syndrome

You may qualify if:

  • PFAPA syndrome patients or FMF patients

You may not qualify if:

  • Participation refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre hospitalier de Versailles

Le Chesnay, France

Location

CH de Bicètre

Paris, France

Location

MeSH Terms

Conditions

Marshall syndrome

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 23, 2016

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

April 1, 2017

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

FR(2)