Status:

NOT_YET_RECRUITING

National Cohort of Patients With SITRAME Syndrome

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Auto Inflammatory Diseases

Eligibility:

All Genders

18+ years

Brief Summary

SITRAME syndrome is a recently described disease. In the absence of epidemiological data on SITRAME syndrome in France, the National Reference Center for Autoinflammatory Diseases proposes coordinatin...

Eligibility Criteria

Inclusion

  • • SITRAME syndrome meeting the diagnostic criteria for the disease
  • All the following criteria must be met:
  • Systemic inflammation: at least 1 documented episode of CRP \>5mg/mL during a skin flare
  • Maculopapular rash on the trunk: fixed, non-itchy maculopapular rash on the trunk appearing within hours with clear borders
  • Recurrence in the same areas: at least 3 different episodes
  • Acute: duration less than 8 days
  • And at least 1 of the following criteria:
  • Fever during flare-ups
  • Flare-ups triggered by infections, vaccinations, or intense physical exercise
  • Fatigue during and/or after flare-ups
  • Associated papular rash
  • And all the following exclusion criteria must be met:
  • No evidence of a monogenic autoinflammatory disease, evolving neoplasm, or evolving autoimmune disease.
  • Adult patients at the time of inclusion
  • Patients not opposed to participating in the research

Exclusion

  • \- Persons with special protection cannot be included in the study:
  • Adults under guardianship or curatorship
  • Hospitalized persons without consent and not legally protected
  • Persons deprived of liberty

Key Trial Info

Start Date :

September 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2055

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT07168746

Start Date

September 1 2025

End Date

September 1 2055

Last Update

September 11 2025

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