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NCT Number: NCT07077473

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

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

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Key information

Conditions

Familial Mediterranean Fever (FMF ) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Familial Mediterranean Fever Genetic Diseases, Inborn Hereditary Autoinflammatory Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

real word drugs

Drug

real word drugs

Primary outcomes

  1. Clinical responses graded as Patient Global Assessment (PGA ) decrease

    Time frame: From baseline,4, 8, 12, 24 and week 52

    The treatment outcome was graded as PGA decrease:in-response, partial response, good response, or clinical remission corresponding to symptomatic improvement <30%, 30% to 50%, 50% to 70%, or >70%, respectively. PGA is a subjective measure where patients rate their overall disease activity or health status on a scale like a visual analog scale (VAS).

Study contacts

Contact information is provided by the study sponsor or research team.

Yikai Yu

CONTACT

[email protected]

86-027-83665519

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

  • Johns Hopkins University
  • Pfizer
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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