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

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Hydroxychloroquine

Criteria

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