Real-world comparison of drugs used to treat Familial Mediterranean Fever

A Retrospective Study Observing the Efficacy and Safety of Different Drugs Used in Real-world Familial Mediterranean Fever (FMF) Cases

We will look at medical records to see if different drugs control symptoms and are safe for people with Familial Mediterranean Fever.

Quick facts

• Study type: Observational
• Enrollment: 12 (estimated)
• Sex: All
• Sponsor: Tongji Hospital (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07077473 on ClinicalTrials.gov

What this trial studies

This retrospective observational project collects medical records from patients with a clinical FMF diagnosis (Tel Hashomer criteria) treated at Tongji Hospital to compare effectiveness and safety of drugs used in routine care. Investigators will extract treatment regimens, attack frequency and severity, laboratory markers, and adverse events to summarize outcomes across drug types. Patients with severe organ dysfunction, active severe infection, pregnancy, substance dependence, or conditions requiring immunosuppression are excluded. The study is coordinated by Tongji Hospital with collaborators at Union Hospital, Huazhong University of Science and Technology, Pfizer, and Johns Hopkins to analyze real-world treatment patterns.

Who should consider this trial

Good fit: Ideal candidates are people diagnosed with FMF by Tel Hashomer criteria who have treatment and outcome records at Tongji Hospital and do not meet exclusion criteria such as pregnancy or severe organ failure.

Not a fit: Patients who are pregnant, have severe cardiac, liver, or kidney dysfunction, active severe infection, a history of substance dependence or serious mental illness, or who require systemic immunosuppression are excluded and unlikely to benefit from this retrospective analysis.

Why it matters

Potential benefit: If successful, this work could identify which commonly used treatments best control FMF attacks and have the fewest safety problems in routine clinical care.

How similar studies have performed: Colchicine and IL-1 blockers have demonstrated efficacy in clinical trials for FMF, but direct real-world comparative data across multiple drugs are limited.

Eligibility criteria

Inclusion Criteria:

\- Clinical diagnosis of Familial Mediterranean fever (FMF) patients (Tel Hashomer criteria)

Exclusion Criteria:

* Have a history of mental illness, or alcohol and drug dependence；
* Pregnant, with severe infection, severe cardiac insufficiency, severe liver or kidney dysfunction；
* Complicated with tumors, organ transplants, etc. which have significant impact on the immune system or require the use of immunosuppressants.

Where this trial is running

Wuhan, Hubei

• Tongji Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Yikai Yu

Conditions Familial Mediterranean Fever