New hope for rare inflammatory disease? sirolimus tested in stubborn cases
NCT ID NCT07151157
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This study tests whether sirolimus, a drug that calms the immune system, can help people with Adult-Onset Still's disease whose symptoms don't improve with standard steroids. Three adults with this rare inflammatory condition will take sirolimus pills for 12 weeks while doctors monitor their fever, rash, joint pain, and blood markers of inflammation. The goal is to see if sirolimus can reduce disease activity and understand how it works at the cellular level.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 3 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age over 18 years; 2. Meeting the Yamaguchi criteria, with infection and malignancy excluded; 3. 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; 4. Complete clinical information; 5. Signed and dated informed consent form; 6. Willingness to comply with study procedures and cooperate throughout the entire study. Exclusion Criteria: 1. Presence of other rheumatic diseases; 2. History of, or planned, hematopoietic stem cell transplantation; 3. 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; 4. Acute conditions such as bowel perforation or complete intestinal obstruction; 5. Pregnant, planning pregnancy, or breastfeeding women; 6. Poor compliance.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ruiiin Hospital Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.