RecruitingPhase 4NCT04981145

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

The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

78 participants

Start Date

Jan 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether iguratimod (IGU), an anti-inflammatory drug, is effective and safe in people with primary Sjögren's syndrome — an autoimmune disease that causes severe dry eyes and dry mouth by attacking the glands that produce moisture. **You may be eligible if...** - You have been diagnosed with primary Sjögren's syndrome - You have symptoms of dry eyes and dry mouth - You test positive for the anti-SSA/Ro-60 antibody - You have not taken hormones, immunosuppressants, or biological drugs in the past 4 weeks **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning to become pregnant - You have another autoimmune condition or cancer - You have serious problems with your heart, liver, kidney, lungs, or blood counts - You are allergic to iguratimod or hydroxychloroquine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIguratimod Tablets

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

DRUGHydroxychloroquine Sulfate Tablets

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


Locations(1)

Second affiliated hospital of zhejiang university,school of medical

Hangzhou, Zhejiang, China

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NCT04981145


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