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

NCT04981145 · Second Affiliated Hospital, School of Medicine, Zhejiang University
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Official title
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study
About this study
A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome
Eligibility 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
Study design
Enrollment target: 78 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-01-14
Estimated completion: 2025-07
Last updated: 2024-10-16
Interventions
Drug: Iguratimod TabletsDrug: Hydroxychloroquine Sulfate Tablets
Primary outcomes
  • The change of SSRI-30 between the two groups at 24 weeks (24 weeks)
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University · other
Contacts & investigators
ContactJing Xue · contact · xuej@zju.edu.cn · 13858121751
InvestigatorYongmei Han · principal_investigator, Sir Run Run Shaw Hospital
InvestigatorHongzhi Wang · principal_investigator, Affiliated Hospital of Jiaxing University
InvestigatorYing Guan · principal_investigator, Zhuji People's hospital
All locations (1)
Second affiliated hospital of zhejiang university,school of medicalRecruiting
Hangzhou, Zhejiang, China
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome · TrialPath