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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT04916756
Eligibility Criteria:
Inclusion Criteria:
1. fulfill the criteria of the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification for primary SS
2. with moderate or high activity of SS, which was defined as EULAR primary SS disease activity index (ESSDAI) ≥5
3. with serological activity defined as elevated C-reactive protein, erythrocyte sedimentation rate (ESR), and/or immunoglobulin G (IgG) level (excluding acute and chronic infection and other factors)
Exclusion Criteria:
1. patients diagnosed with an active central nervous system disease or dysfunction of a major organ (heart, liver, kidney)
2. pregnant or lactating women
3. current severe infections
4. undergoing glucocorticoids or immunosuppressants treatment with stable dosage for less than 12 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04916756
Study Brief:
Protocol Section:
NCT04916756