Familial Mediterranean Fever (FMF )NCT07077473
Observing the Efficacy and Safety of Different Drugs Used in Real-world Familial Mediterranean Fever (FMF) Cases
An observational study of Familial Mediterranean Fever (FMF ), run by Tongji Hospital at 1 site in China.
Trial summary
retrospective observe the efficacy and safety of different drugs used in familial Mediterranean fever (FMF) cases in real-world Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Familial Mediterranean Fever (FMF )
- What is being tested?
- real word drugs
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: familial Mediterranean fever (FMF) patients
Who may be able to join
- Clinical diagnosis of Familial Mediterranean fever (FMF) patients (Tel Hashomer criteria)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
YIKAI YU, 15617678920, yuyikai@163.com
About this study
Official title: A Retrospective Study 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
- Conditions
- Familial Mediterranean Fever (FMF )
- Being tested
- real word drugs
- Medical subject headings
- Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real word drugsDrug
real word drugs
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline,4, 8, 12, 24 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean Fever (FMF )Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Pfizer, Johns Hopkins University
- Responsible party
- Principal investigator, YIKAI YU, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077473
- Sponsor's protocol ID
- TJ-IRB202412016
- Status last verified
- Jan 2026
- First submitted
- 21 Jun 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Observing the Efficacy and Safety of Different Drugs Used in Real-world Familial Mediterranean Fever (FMF) Cases
- ClinicalTrials.gov ID
- NCT07077473
- Acronym / sponsor ID
- TJ-IRB202412016
- Conditions
- Familial Mediterranean Fever (FMF )
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Pfizer, Johns Hopkins University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
retrospective observe the efficacy and safety of different drugs used in familial Mediterranean fever (FMF) cases in real-world
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- familial Mediterranean fever (FMF) patients
Key inclusion criteria (1 listed)
- Clinical diagnosis of Familial Mediterranean fever (FMF) patients (Tel Hashomer criteria)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real word drugsreal word drugs | Drug | – |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Mediterranean Fever (FMF ), run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yikai Yu (86-027-83665519, yuyikai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical responses graded as Patient Global Assessment (PGA ) decrease (time frame: From baseline,4, 8, 12, 24 and week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.