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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT02149420
Eligibility Criteria:
INCLUSION CRITERIA:
* Fulfilled revised European US consensus criteria for pSS
* ESSDAI value ≥ 6
* Elevated serum titers at screening of ANA (≥ 1:160)
* Seropositive at screening for anti-SSA and/or anti-SSB antibodies
* Stimulated whole salivary flow rate at screening of \> 0 mL/min
EXCLUSION CRITERIA:
\- Prior or previous use of (specific dosages and intervals prior to study start may apply): B-cell depleting therapy (e.g., rituximab), Prednisone, anti-BAFF mAb, CTLA4-Fc Ig (abatacept), anti-TNF-α mAb, cyclophosphamide, azathioprine and medications known to cause dry mouth.
Hydroxychloroquine or methotrexate in a consistent dose for ≥ 3 months prior to randomization is allowed
* Active or recent history of clinically significant infection
* Vaccination within 2 month prior to study
* History of primary or secondary immunodeficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02149420
Study Brief:
Protocol Section:
NCT02149420