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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01758393
Eligibility Criteria:
Inclusion Criteria:
* Males and females
* Age 18-70 years old with informed consent
* Patients with IgG4-RD:
1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
2. elevated serum IgG4 (\>1.35 g/L)
3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
4. exclusion of other diseases.
Exclusion Criteria:
* Previously or currently received glucocorticoid and(or) immunomodulator
* Pregnancy or lactating
* Concurrent severe and/or uncontrolled and/or unstable diseases
* Patient with malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01758393
Study Brief:
Protocol Section:
NCT01758393