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New study aims to uncover mysteries of rare SITRAME syndrome

NCT ID NCT07168746

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study will collect information from 100 people in France with SITRAME syndrome, a rare autoinflammatory disease. Researchers want to learn about the disease's symptoms, treatments, and outcomes. No new treatments are being tested; the goal is simply to better understand the condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could provide the first clear picture of how SITRAME syndrome affects people in France, helping doctors recognize and manage it better.
What could go wrong
This is an observational study, not a treatment trial. It will not test any new therapy, and results may take years to gather and analyze.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2055

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: • SITRAME syndrome meeting the diagnostic criteria for the disease All the following criteria must be met: 1. Systemic inflammation: at least 1 documented episode of CRP \>5mg/mL during a skin flare 2. Maculopapular rash on the trunk: fixed, non-itchy maculopapular rash on the trunk appearing within hours with clear borders 3. Recurrence in the same areas: at least 3 different episodes 4. Acute: duration less than 8 days And at least 1 of the following criteria: 1. Fever during flare-ups 2. Flare-ups triggered by infections, vaccinations, or intense physical exercise 3. Fatigue during and/or after flare-ups 4. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.