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:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT06663618
Eligibility Criteria:
Inclusion Criteria:
1. 18-80 years old;
2. All patients must meet the comprehensive diagnostic criteria of IgG4-RD revised in Japan in 2020 or the classification criteria of IgG4-RD formulated by ACR/EULAR in 2019;
3. Active IgG4-RD (at least one organ has an IgG4-RD reaction score \>=2 at the time of enrollment.)；
4. No previous medication or recurrence after withdrawal.
Exclusion Criteria:
1. Combined with other autoimmune diseases as the main diagnosis.
2. Pregnant or lactating women
3. Patients with malignant tumor
4. Active bacterial, fungal, viral or mycobacterial infections.
5. Severe complications of important organs, and the expected survival time is less than 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06663618
Study Brief:
Protocol Section:
NCT06663618