Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT07151157
Eligibility 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:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07151157
Study Brief:
Protocol Section:
NCT07151157