Real-world comparison of drugs used to treat Familial Mediterranean Fever
Official title: A Retrospective Study Observing the Efficacy and Safety of Different Drugs Used in Real-world Familial Mediterranean Fever (FMF) Cases
Run by Tongji Hospital · NCT07077473 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 12 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | January 1, 2018 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | January 27, 2026 |
| Trial ID | NCT07077473 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Colchicine and IL-1 blockers have demonstrated efficacy in clinical trials for FMF, but direct real-world comparative data across multiple drugs are limited.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Tongji Hospital
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Yikai Yu
- Email: yuyikai@163.com
- Phone: 86-027-83665519
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Low-Calorie Diet in adolescents with Familial Mediterranean Fever and metabolic syndrome
A group of adolescents with both FMF and metabolic syndrome will try a low-calorie diet for 3 months to see if it helps manage metabolic symptoms.
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Exploring genetics and characteristics of familial Mediterranean fever and related disorders
This study is trying to understand the genetics and symptoms of diseases that cause fever, like familial Mediterranean fever, by looking at patients, their families, and healthy volunteers.
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Canakinumab use in FMF and Still's disease patients across real-world care
This real-world study looks at how people with FMF or Still's disease who were treated with canakinumab fare over at least 6 months.
-
Mediterranean diet with or without aerobic exercise for women with familial Mediterranean fever and fatty liver
This trial will test whether adding regular aerobic exercise to a Mediterranean diet helps women with familial Mediterranean fever who have non-alcoholic fatty liver disease.
-
Whole-body vibration plus vitamin D for adolescent girls with familial Mediterranean fever
This project will try adding regular whole-body vibration sessions to vitamin D and usual colchicine for girls aged 13–17 with familial Mediterranean fever to see if it improves fitness, muscle strength, and bone mass.
-
Inspiratory muscle training for adolescents with Familial Mediterranean Fever
This trial will try a daily inspiratory muscle training program to see if it improves breathing strength, exercise tolerance, and fatigue in teenagers (ages 13–17) with Familial Mediterranean Fever who are taking colchicine.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.