Auto Inflammatory DiseasesCO-SITRAMENCT07168746
National Cohort of Patients With SITRAME Syndrome
An observational study of Auto Inflammatory Diseases, run by Assistance Publique - Hôpitaux de Paris.
Trial 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 coordinating a database to collect both retrospective and prospective cases of this rare disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auto Inflammatory Diseases
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2055
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited in France via the national reference center for autoinflammatory diseases at Tenon Hospital (Internal Medicine, Dermatology and Allergology Department at Tenon Hospital).
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Auto Inflammatory Diseases
- Keywords
- SITRAME, autoinflammatory diseases, cohort
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the sexe at the diagnosis of the disease in order to describe the clinical characteristics of patients followed for SITRAME syndrome
Measured: Day 0- Baseline
Description of the age at the diagnosis of the disease
Description of the age at the diagnosis of the disease in order to describe the clinical characteristics of patients followed for SITRAME syndrome
Measured: Day 0- Baseline
Description of cardiovascular co-morbidity
Description of cardiovascular co-morbidity at the diagnosis of the disease in order to describe the clinical characteristics of patients followed for SITRAME syndrome
Measured: Day 0- Baseline
Description of presence of an allergical context
Description of presence of an allergical context in order to describe the clinical characteristics of patients followed for SITRAME syndrome
Measured: Day 0- Baseline
Description of the different therapeutic lines
Description of the different therapeutic lines in order to describe the clinical characteristics of patients followed for SITRAME syndrome
Measured: Year 15
Description of the age at death
Description of the age at death in order to describe the clinical characteristics of patients followed for SITRAME syndrome
Measured: Day 0- Baseline
Secondary outcomes (28)
Measure of the prevalence of this disease annually using the register of newly included patients
Measured: Every year up to 15 years
Measure of the incidence of this disease
Measure of the incidence of this disease annually using the register of newly included patients Time frame: annually
Measured: Every year up to 15 years
Description of the rare clinical manifestations (outside of the well-established disease criteria)
Measured: Year 15
Description of the rare biological manifestations (outside of the well-established disease criteria)
Measured: Year 15
Measure of the number of patients eligible for various clinical research studies on SITRAME syndrome
Measured: Every year up to 15 years
Measure of the proportion of patients using targeted therapies throughout the study
Measured: Year 15
Measure of the number of deaths in patients followed for SITRAME syndrome
Measured: every 5 years up to 15 years
Description of the death causes in patients followed for SITRAME syndrome
Measured: every 5 years up to 15 years
Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (pulmonary manifestations)
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
Measured: every 5 years up to 15 years
Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (cardiac manifestations)
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
Measured: Every 5 years up to 15 years
Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (neurological manifestations)
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
Measured: every 5 years up to 15 years
Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (gastrointestinal manifestations)
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
Measured: every 5 years up to 15 years
C-reactive protein (CRP) rate in the population of dead patients followed for SITRAME syndrome
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
Measured: 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
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
Measured: every 5 years up to 15 years
Ferritin rate of the dead patient followed for SITRAME syndrome
Ferritin rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Liver enzymes rate of the dead patient followed for SITRAME syndrome
Liver enzymes rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Creatinine rate of the dead patient followed for SITRAME syndrome
Creatinine rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Red blood cells rate of the dead patient followed for SITRAME syndrome
Red blood cells rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Platelets rate of the dead patient followed for SITRAME syndrome
Platelets rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Hemoglobin rate of the dead patient followed for SITRAME syndrome
Hemoglobin rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Hematocrit rate of the dead patient followed for SITRAME syndrome
Hematocrit rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Mean corpuscular volume (MCV) rate of the dead patient followed for SITRAME syndrome
Mean corpuscular volume (MCV) rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
White blood cells rate of the dead patient followed for SITRAME syndrome
White blood cells rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Neutrophils rate of the dead patient followed for SITRAME syndrome
Neutrophils rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Lymphocytes rate of the dead patient followed for SITRAME syndrome
Lymphocytes rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Monocytes rate of the dead patient followed for SITRAME syndrome
Monocytes rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Eosinophils rate of the dead patient followed for SITRAME syndrome
Eosinophils rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Basophils rate of the dead patient followed for SITRAME syndrome
Basophils rate of the dead patient followed for SITRAME syndrome in order to describe the biological characteristics of this population
Measured: every 5 years up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2055 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auto Inflammatory DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angele SORIA, PUPH, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168746
- Sponsor's protocol ID
- APHP250008
- Acronym
- CO-SITRAME
- Status last verified
- Aug 2025
- First submitted
- 17 Jun 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Cohort of Patients With SITRAME Syndrome
- ClinicalTrials.gov ID
- NCT07168746
- Acronym / sponsor ID
- CO-SITRAME / APHP250008
- Conditions
- Auto Inflammatory Diseases
- Keywords
- SITRAME, autoinflammatory diseases, cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2055 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in France via the national reference center for autoinflammatory diseases at Tenon Hospital (Internal Medicine, Dermatology and Allergology Department at Tenon Hospital).
Key inclusion criteria (15 listed)
- SITRAME syndrome meeting the diagnostic criteria for the disease
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
28 secondary outcomes
Measure of the prevalence of this disease annually using the register of newly included patients
Time frame: Every year up to 15 years
Measure of the incidence of this disease
Time frame: Every year up to 15 years
Description of the rare clinical manifestations (outside of the well-established disease criteria)
Time frame: Year 15
Description of the rare biological manifestations (outside of the well-established disease criteria)
Time frame: Year 15
Measure of the number of patients eligible for various clinical research studies on SITRAME syndrome
Time frame: Every year up to 15 years
Measure of the proportion of patients using targeted therapies throughout the study
Time frame: Year 15
Measure of the number of deaths in patients followed for SITRAME syndrome
Time frame: every 5 years up to 15 years
Description of the death causes in patients followed for SITRAME syndrome
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)
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)
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)
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)
Time frame: every 5 years up to 15 years
C-reactive protein (CRP) rate 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
Time frame: every 5 years up to 15 years
Ferritin 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
Time frame: every 5 years up to 15 years
Creatinine 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
Time frame: every 5 years up to 15 years
Platelets 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
Time frame: every 5 years up to 15 years
Hematocrit 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
Time frame: every 5 years up to 15 years
White blood cells 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
Time frame: every 5 years up to 15 years
Lymphocytes 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
Time frame: every 5 years up to 15 years
Eosinophils 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
Time frame: every 5 years up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angele SORIA, PUPH, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Auto Inflammatory Diseases, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angele SORIA, PU-PH, MD, PhD (00 33 1 56 01 72 20, angele.soria@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.