Auvergne-Rhône-Alpes-Limousin Research Database for Still's Diseases in Children and Adults (AURAL-STILL)

April 25, 2024 updated by: Hospices Civils de Lyon

Adult-Onset Still's disease is a polygenic autoinflammatory disease of unknown etiology. The autoinflammatory character individualizes it from autoimmune autoantibody diseases. Clinically, it results in the classic triad associating hectic fever, evanescent rash and arthritis. Although it is benign in the vast majority of cases, life-threatening complications can occur. By definition, the disease affects adults over 16 years of age, however most experts now agree that the adult form and the pediatric form belong to a pathological continuum: Still's disease. In the absence of a specific biomarker, the diagnosis is still based on clinical and biological criteria, after the exclusion of differential diagnoses.

Classically, three evolutionary profiles of Adult-Onset Still's disease are individualized, depending on the evolution of symptoms over time:

  • a monocyclic systemic form (30% of cases) characterized by clear systemic symptoms and in the foreground compared to the articular signs. This form evolves over several weeks to several months (on average 9 months), without exceeding a year. By definition, there is no recurrence;
  • a polycyclic systemic form (30% of cases) defined by the occurrence of at least two systemic or joint episodes, separated by clinical remission intervals greater than two months, or even several years. The symptoms of relapses are not always the same as the initial symptoms. The number and severity of relapses is unpredictable and varies widely from patient to patient, but symptoms tend to become less severe over time.
  • a chronic form, with predominant joint involvement (40%), resembling seronegative rheumatoid arthritis. Systemic signs are present during the first outbreaks of the disease. Subsequently, rheumatoid arthritis evolves on its own and one can see joint destruction or conversely ankylosing developments such as the classic bilateral, non-erosive fusing carpitis.

There are reasons to believe that the evolving profile of patients has changed since the emergence and generalization of biotherapies. Furthermore, no prognostic factor for the progression of Adult-Onset Still's disease has been found so far. The differences between pediatric and adult forms need to be confirmed and becoming pediatric forms in adulthood is poorly described.

The objective of this study is to set up a regional research database (Auvergne-Rhône-Alpes-Limousin) in order to describe the characteristics, treatment and evolution of patients with Still's disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Annecy, France, 74370
      • Bourg en Bresse, France, 01012
        • Recruiting
        • Centre Hospitalier de Bourg en Bresse
        • Contact:
      • Bourgoin-Jallieu, France, 38300
      • Chambéry, France, 73000
      • Châlon sur Saône, France, 71321
      • Contamine-sur-Arve, France, 74130
        • Recruiting
        • Centre Hospitalier Alpes-Léman (CHAL)
        • Contact:
      • Le Puy-en-Velay, France, 43000
        • Recruiting
        • Centre Hospitalier du puy en velay
        • Contact:
      • Limoges, France, 87000
      • Lyon, France, 69007
      • Lyon, France, 69008
        • Recruiting
        • Hospices Civils de Lyon - Edouard Herriot
        • Contact:
      • Montélimar, France, 26200
      • Vienne, France, 38200
      • Villefranche-sur-Saône, France, 69400
      • Villeurbanne, France, 69100
    • Drome
      • Valence, Drome, France, 26953
    • Rhone Alpes
      • Lyon, Rhone Alpes, France, 69004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children and adult diagnosed with Still's disease in Auvergne-Rhône-Alpes-Limousin hospital

Description

Inclusion Criteria:

  • children and adult diagnosed with Still's disease in Auvergne-Rhône-Alpes-Limousin hospital

Exclusion Criteria:

  • Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children and adult diagnosed with Still's disease in Auvergne-Rhône-Alpes-Limousin hospital
children and adult with Still's disease in Auvergne-Rhône-Alpes-Limousin hospital
Other: children and adult with Still's disease in Auvergne-Rhône-Alpes-Limousin hospital
Comparison of Adult-Onset Still's disease phenotypes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
validation of classification criteria
Time Frame: at inclusion
number of participants with clinical and biological abnormalities, as assessed in the Yamaguchi and Fautrel criteria
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 24, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC_GHN_2021_003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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