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

NCT07077473 | Recruiting DMC FDA Drug

• 1 other identifier: TJ-IRB202412016
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Familial Mediterranean Fever (FMF )

Outcome Measures

Primary Outcomes (1)

• Clinical responses graded as Patient Global Assessment (PGA ) decrease

  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).

  From baseline,4, 8, 12, 24 and week 52

Interventions

real word drugs DRUG

real word drugs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

familial Mediterranean fever (FMF) patients

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Familial Mediterranean Fever

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yikai Yu

CONTACT

86-027-83665519; yuyikai@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: July 22, 2025
• Study Start: January 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)