RecruitingPhase 4NCT04981145

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

78 participants

Start Date

Jan 14, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

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

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

DRUGIguratimod Tablets

Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.

DRUGHydroxychloroquine Sulfate Tablets

Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.

Second affiliated hospital of zhejiang university，school of medical

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT04981145