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RecruitingNCT07077473Updated Jan 27, 2026

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

An observational study in Familial Mediterranean Fever (FMF ), sponsored by Tongji Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Tongji Hospital · Observational

From the registry’s dates

  • Started Jan 2018; still recruiting 8 years 10 months later.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
12
Sex
All
01

Study summary

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

02

Conditions studied

  • Familial Mediterranean Fever (FMF )
03

In context

Familial Mediterranean Fever

61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.

This study's planned enrollment of 12 is below the median of 89 across 30 observational studies indexed under Familial Mediterranean Fever.

Browse Familial Mediterranean Fever studies →

Lead sponsor

Tongji Hospital is the lead sponsor of 387 studies on the registry; 210 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

familial Mediterranean fever (FMF) patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion 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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
12 participants (estimated)
Patient registry
No

Interventions

  • Drugreal word drugs

    real word drugs

06

What researchers measure

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).

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2018 (actual). Primary completion is estimated for Dec 2026, 107 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2025
First posted
Jul 22, 2025
StartActual
Jan 1, 2018
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jan 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07077473
Lead sponsor
Tongji Hospital
Responsible party
YIKAI YU (Doctor, Tongji Hospital) — Principal investigator
First posted
Jul 22, 2025
Start date
Jan 1, 2018
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 27, 2026

Study contacts

Yikai Yu
Contact
yuyikai@163.com
86-027-83665519

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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