The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome

The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study

A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome

Inclusion Criteria:

• Diagnosed with pSS by meeting the 2016 ACR/EULAR Classification Criteria.
• The patient complained of dry mouth and eyes.
• Positive anti-SSA/Ro-60 antibody at screening.
• IgG≥16 g/L.
• No hormone, immunosuppressant, biological agents or other treatments were received within 4 weeks before screening;
• Pregnancy test of is negative. Use effective contraceptives during the trial (female)
• Those who did not participate in any drug trial within 12 weeks before enrollment

Exclusion Criteria:

• Pregnant or lactating or planning to get pregnant during the duration of the study.
• Complicated with other CTD
• Complicated with malignancy
• mental illness, a history of alcohol abuse, immunodeficiency, uncontrolled infections, and drug or other substance abuse
• serious systemic damage, glucocorticoids, other immunosuppressants and biological agents should be added to control the condition: Heart, liver (transaminase/bilirubin >1.5 times the upper normal limit), kidney (Cr≥133mmol/L), lung (FVC % < 60%), blood (white blood cell <3×109/L, HGB<80g/L, PLT<80×109/L), etc.
• Fundus/visual field lesions;
• Allergic to any component of the study drug (IGU and/or HCQ);
• the investigator considers the patient to be unsuitable for entry into the study