Status:
ACTIVE_NOT_RECRUITING
Therapeutic Value of Sirolimus in Refractory Adult-Onset Still's Disease
Lead Sponsor:
Ruijin Hospital
Conditions:
Adult-Onset Still's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study aims to further evaluate the anti-inflammatory effects of the mTOR inhibitor sirolimus in patients with adult-onset Still's disease (AOSD), and to verify whether it can reduce inflammation ...
Eligibility Criteria
Inclusion
- Age over 18 years;
- Meeting the Yamaguchi criteria, with infection and malignancy excluded;
- Meeting the definition of refractory AOSD, i.e., patients whose symptoms show no significant improvement after treatment with glucocorticoids at 1 mg/kg, or who experience relapse during tapering of glucocorticoids to 15 mg/d;
- Complete clinical information;
- Signed and dated informed consent form;
- Willingness to comply with study procedures and cooperate throughout the entire study.
Exclusion
- Presence of other rheumatic diseases;
- History of, or planned, hematopoietic stem cell transplantation;
- Presence of severe comorbidities considered by the investigator to be unsuitable for participation in this clinical study, such as severe cardiac or pulmonary insufficiency, severe bone marrow suppression, or severe hepatic or renal dysfunction;
- Acute conditions such as bowel perforation or complete intestinal obstruction;
- Pregnant, planning pregnancy, or breastfeeding women;
- Poor compliance.
Key Trial Info
Start Date :
August 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT07151157
Start Date
August 30 2025
End Date
August 30 2026
Last Update
November 17 2025
Active Locations (1)
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1
Ruiiin Hospital Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025