Study of Iguratimod in Sjögren's Syndrome

A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome

A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome

In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.

Inclusion Criteria:

• A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
• Positive dry eyes and (or) dry mouth symptoms
• Hyperglobulinemia

Exclusion Criteria:

• Complicated with other systemic autoimmune diseases
• Severe complications of Sjogren's syndrome
• Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit
• Active infections or chronic infectious diseases
• A history of malignancies
• Pregnancy or breathfeeding
• Inability to comply with the study protocol for any other reason