Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome

Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)

The ESSPRI is a patient self-reported outcome measure to assess dryness, limb pain, fatigue and mental fatigue, where each of the domains normally reported as 0 (not at all) to 10 (extremely severe). The final ESSPRI score is the average of three: dryness, pain and fatigue. A reduction from baseline indicates the improvement of symptoms.

Time frame: Baseline and Week 12

Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)

The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).

Time frame: Baseline and Week 12

Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)

The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).

Time frame: Baseline and Week 12

Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score

The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.