← Back to searchRecruitingRecruiting
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome
NCT04981145 · Second Affiliated Hospital, School of Medicine, Zhejiang University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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