🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT04981145
Recruiting Phase 4

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

NCT04981145 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 4
Started
2022-01-14
Last updated
2024-10-16

Condition(s) studied

Primary Sjögren's Syndrome

Investigational drug(s) / intervention(s)

Iguratimod Tablets →Hydroxychloroquine Sulfate Tablets

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

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Second affiliated hospital of zhejiang university,school of medical Hangzhou Zhejiang Recruiting

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04981145 on ClinicalTrials.gov ↗ ← All trials in China