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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT02962895
Eligibility Criteria:
Inclusion Criteria:
* Fulfilled revised American European Consensus Group criteria for pSS
* Seropositive at screening for anti-Ro/SSA antibodies
* Screening ESSDAI value \>=6 scored from 7 domains: articular, cutaneous, glandular, lymphoadenopathy, constitutional, biologic and hematologic.
Exclusion Criteria:
* Secondary Sjogren's syndrome
* Use of other investigational drugs
* Active viral, bacterial or other infections
* Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02962895
Study Brief:
Protocol Section:
NCT02962895