Study assessments and endpoints
salivary glandThe primary endpoint, SS disease
ADVERSE EVENTS, MINOR
Assessments of SS disease activity, symptoms and quality of life were carried out before (at baseline), during and upon completion of the study treatment phase, at early termination visits, and at the safety and follow-up visit (Overview of study design. BL: baseline; MSG: minor salivary glandThe primary endpoint was the proportion of patients who had a ≥3 point reduction from baseline in the ESSDAI score after 12 weeks of treatment [Safety assessments consisted of monitoring and recording adverse events (AEs), including serious AEs (SAEs) and non-serious AEs of special interest, monitoring of vital signs (systolic blood pressure, diastolic blood pressure, pulse rate), safety ECGs and laboratory safety tests.