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

Recruiting

• Conditions: Familial Mediterranean Fever (FMF )

• Registration Number: NCT07077473
• Lead Sponsor: Tongji Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2025-06-21
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical responses graded as Patient Global Assessment (PGA ) decrease	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).

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China