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

Recruiting now · Phase 4

Conditions studied: Primary Sjögren's Syndrome

In brief

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

Key facts

Study ID

NCT04981145

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

78

Starts

2022-01-14

Expected to finish

2025-07-01

Last updated by the study team

2024-10-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Second affiliated hospital of zhejiang university，school of medical — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.