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NCT Number: NCT07168746

National Cohort of Patients With SITRAME Syndrome

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 coordinating a database to collect both retrospective and prospective cases of this rare disease.

Currently, there are no available data on the epidemiology or treatment of SITRAME syndrome in France or globally. The importance of this research is to provide an overview of demographic, etiological, and disease progression data for patients with SITRAME syndrome in France. This will allow the establishment of quantitative data on the morbidity and mortality of this rare disease.

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Key information

Conditions

Auto Inflammatory Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Description of the sexe at the diagnosis of the disease in order to describe the clinical characteristics of patients followed for SITRAME syndrome

    Time frame: Day 0- Baseline

  2. Description of the age at the diagnosis of the disease

    Time frame: Day 0- Baseline

    Description of the age at the diagnosis of the disease in order to describe the clinical characteristics of patients followed for SITRAME syndrome

  3. Description of cardiovascular co-morbidity

    Time frame: Day 0- Baseline

    Description of cardiovascular co-morbidity at the diagnosis of the disease in order to describe the clinical characteristics of patients followed for SITRAME syndrome

  4. Description of presence of an allergical context

    Time frame: Day 0- Baseline

    Description of presence of an allergical context in order to describe the clinical characteristics of patients followed for SITRAME syndrome

  5. Description of the different therapeutic lines

    Time frame: Year 15

    Description of the different therapeutic lines in order to describe the clinical characteristics of patients followed for SITRAME syndrome

  6. Description of the age at death

    Time frame: Day 0- Baseline

    Description of the age at death in order to describe the clinical characteristics of patients followed for SITRAME syndrome

Secondary outcomes

  1. Measure of the prevalence of this disease annually using the register of newly included patients

    Time frame: Every year up to 15 years

  2. Measure of the incidence of this disease

    Time frame: Every year up to 15 years

    Measure of the incidence of this disease annually using the register of newly included patients Time frame: annually

  3. Description of the rare clinical manifestations (outside of the well-established disease criteria)

    Time frame: Year 15

  4. Description of the rare biological manifestations (outside of the well-established disease criteria)

    Time frame: Year 15

  5. Measure of the number of patients eligible for various clinical research studies on SITRAME syndrome

    Time frame: Every year up to 15 years

  6. Measure of the proportion of patients using targeted therapies throughout the study

    Time frame: Year 15

  7. Measure of the number of deaths in patients followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

  8. Description of the death causes in patients followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

  9. Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (pulmonary manifestations)

    Time frame: every 5 years up to 15 years

    Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (pulmonary manifestations) in order to describe the clinical characteristics of this population

  10. Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (cardiac manifestations)

    Time frame: Every 5 years up to 15 years

    Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (cardiac manifestations) in order to describe the clinical characteristics of this population

  11. Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (neurological manifestations)

    Time frame: every 5 years up to 15 years

    Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (neurological manifestations) in order to describe the clinical characteristics of this population

  12. Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (gastrointestinal manifestations)

    Time frame: every 5 years up to 15 years

    Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (gastrointestinal manifestations) in order to describe the clinical characteristics of this population

  13. C-reactive protein (CRP) rate in the population of dead patients followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    C-reactive protein (CRP) rate in the population of dead patients followed for SITRAME syndrome in order to describe the biological characteristics of this population

  14. Frequency of inflammatory flares throughout the disease course in the population of dead patients followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Frequency of inflammatory flares throughout the disease course in the population of dead patients followed for SITRAME syndrome in order to describe the biological characteristics of this population

  15. Ferritin rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Ferritin rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  16. Liver enzymes rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Liver enzymes rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  17. Creatinine rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Creatinine rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  18. Red blood cells rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Red blood cells rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  19. Platelets rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Platelets rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  20. Hemoglobin rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Hemoglobin rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  21. Hematocrit rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Hematocrit rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  22. Mean corpuscular volume (MCV) rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Mean corpuscular volume (MCV) rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  23. White blood cells rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    White blood cells rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  24. Neutrophils rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Neutrophils rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  25. Lymphocytes rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Lymphocytes rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  26. Monocytes rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Monocytes rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  27. Eosinophils rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Eosinophils rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

  28. Basophils rate of the dead patient followed for SITRAME syndrome

    Time frame: every 5 years up to 15 years

    Basophils rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population

Study contacts

Contact information is provided by the study sponsor or research team.

Angele SORIA, PU-PH, MD, PhD

CONTACT

[email protected]

00 33 1 56 01 72 20

Sophie GEORGIN-LAVIALLE, PUPH, MD, PhD

CONTACT

[email protected]

00 33 1 56 01 74 31

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: CO-SITRAME

Important dates

Study start
2025
Primary completion
2025
Study completion
2055
First posted
Sep 11, 2025
Registry last updated
Sep 11, 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.