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Completed

NCT Number: NCT03569644

Quality of Life in Patients With Auto-inflammatory Diseases

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH André Mignot, Le Chesnay, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ...)

Treatment and study plan

Qualitative study

Other

Interviews

Primary outcomes

  1. Qualitative evaluation of quality of life by interviews of patients and/or parents

    Time frame: 45 to 90 min

    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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Creation of a Tool to Assess Quality of Life in Patient With Auto-inflammatory Diseases

Acronym: MAI-PATIENT

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Jun 26, 2018
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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