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

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Jul 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a medication called Iguratimod (IGU) for treating Primary Sjögren's Syndrome (pSS), a condition that causes dry mouth and eyes. The trial is currently recruiting participants aged 18 to 75 who have been diagnosed with pSS and have specific symptoms, such as dry mouth and eyes, along with certain positive blood tests. To join, participants should not have received any other treatments for at least four weeks before the study and must not be pregnant.

Participants in this study will take Iguratimod and will be monitored by healthcare professionals to see how well the medication works and if there are any side effects. It's important for potential participants to know that those with other serious health conditions, pregnant women, or individuals with certain medical histories may not be eligible for the trial. This study aims to gather important information to help improve treatment options for people with Primary Sjögren's Syndrome.

Gender

ALL

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