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Therapeutic Value of Sirolimus in Refractory Adult-Onset Still’s Disease

Therapeutic Value of Sirolimus in Refractory Adult-Onset Still’s Disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108227
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-08-30
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adult-onset Still’s disease

Interventions

Sirolimus combination therapy group:Sirolimus combination therapy

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
AOSD Disease Activity Score;

Secondary

MeasureTime frame
AOSD Disease Activity Score;CRP, ESR, serum ferritin, soluble interleukin-2 receptor (sIL-2R), and multiple inflammatory cytokines;Expression level of ZFP36L2 in neutrophils;Clinical symptoms such as rash and arthralgia;

Countries

China

Contacts

Public ContactHonglei Liu

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

hong-lei-liu@163.com+86 21 6437 0045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026