Quality of Life in Patients With Auto-inflammatory Diseases | NCT03569644

Studies
Quality of Life in Patients With Auto-inflammatory Diseases

NCT03569644

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Oct 2, 2025Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Hereditary Autoinflammatory Diseases

Interventions

qualitative study

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-A02673-50	Other Identifier	ANSM

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2018Actual

Primary Completion Date

Nov 6, 2019Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

Jun 15, 2018

First Submission Date that Met QC Criteria

Jun 25, 2018

First Posted Date

Jun 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2025

Last Update Posted Date

Oct 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This qualitative interview-based study aim to build a tool to assess quality of life in patients (adults or children) suffering from 6 autoinflammatory diseases (FMF, TRAPS, CAPS, MKD, Still and PFAPA).

Detailed Description

Recent understanding of the physiopathological mechanisms that underpin autoinflammatory diseases (AIDs) allowed a revolution in the therapeutic management of these patients, particularly through the use of biotherapies. However new treatments need to be evaluated by valid tools. AIDAI score created and validated by our team evaluates activity of 4 autoinflammatory diseases. One of the important components, not explored by the scores currently available, is the impact of these treatments on quality of life (QoL) of patients. The existing quality of life scales are not adapted to these recurrent chronic pathologies. Throught a qualitative study based on interviews of patients and/ or parents, the investigators aim to build a tool to evaluate QoL in patients suffering from 6 aAIDs :familial Mediterranean fever (FMF), mevalonate kinase deficiency (MKD), tumour necrosis factor receptor-associated periodic syndrome (TRAPS), cryopyrin-associated periodic syndromes (CAPS), Still's disease and PFAPA syndrome.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
qualitative study	Other	heterogeneous group of patients	Other: qualitative study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
qualitative study	Other	Interviews	qualitative study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Qualitative evaluation of quality of life by interviews of patients and/or parents	The interviews will be recorded in digital audio and then transcribed literally. The analysis will be phenomenological. Four age group will be interviewed : < 6 year-old (parents), 6 to 12 year-old (patients and parents) , 13 to 17 year-old (patients and parents) , > 18 year-old (patients)	45 to 90 min

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient (child and adult) with one of the 6 AIDs (FMF, TRAPS, MKD or CAPS, PFAPA or Still's disease) regardless of the activity of the disease. The diagnosis will have been made by the referring physician according to criteria specific to each AIDs
Volunteer to participate in the study
With at least one parent present at the consultation if it is a child under 18 years old
For minors, agreement of the parents or their legal representative or one of the present parents
Information for children as far as their age and condition allow
Affiliation to a national health insurance.

Exclusion Criteria:

patient or relative (according to age)refuse to participate.
Bad understanding of French.
Other chronic inflammatory pathology associated (example: Crohn's, SPA, uveitis, psoriasis ...)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CH André Mignot		Le Chesnay	France	78150	France
TENON

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056660	Hereditary Autoinflammatory Diseases

Ancestor Terms

ID	Term
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012873	Skin Diseases, Genetic
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

The study is based on interviews that will be recorded in digital audio and then transcribed literally. The consultation for this research is 45 to 90 minutes long. This prolongs their presence in consultation with the doctor. For this reason, the study was classified as Interventional according to French regulations