ClinicalTrials.gov record NCT07077473

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This retrospective study reviews medical records of people diagnosed with Familial Mediterranean Fever (FMF). It observes which drugs were used in routine care and records symptom changes and safety events. Symptom change is measured by Patient Global Assessment at baseline and at several follow-up times up to week 52.

What it is studying. How different drugs used in real-world FMF relate to changes in patient-reported disease activity (Patient Global Assessment) over time, and the safety events recorded.

What the researchers hope to learn. To describe the real-world efficacy and safety of different drugs used in FMF and to classify clinical responses over time using Patient Global Assessment.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

retrospective observe the efficacy and safety of different drugs used in familial Mediterranean fever (FMF) cases in real-world

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • real word drugs

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a retrospective observational study: participation involves researchers reviewing past medical records. Data collected will include which drugs were used, safety information, and clinical responses measured by Patient Global Assessment (PGA) at baseline and at weeks 4, 8, 12, 24, and 52. The registry does not describe any new tests, treatments, or invasive procedures for participants.

How the study is structured. A retrospective cohort observational study. Researchers review past medical records of FMF patients treated with various drugs, record safety events, and measure symptom change by Patient Global Assessment at baseline and at weeks 4, 8, 12, 24, and 52.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 1, 2018
Primary completion
Dec 31, 2026 (estimated)
Study completion
Dec 31, 2026 (estimated)
Target enrollment
12 participants (estimated)
Last updated on registry
Jan 27, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Tongji Hospital
Principal investigator
YIKAI YU, Doctor
Tongji Hospital
Collaborators
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Pfizer
  • Johns Hopkins University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

immunosuppressants
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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