Recruiting NCT04981145

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

Phase IV Interventional Primary Sjögren's Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Iguratimod Tablets, Hydroxychloroquine Sulfate Tablets.
Who it may be relevant to: Registry conditions: Primary Sjögren's Syndrome. Basic parameters: 18 years — 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Drug Iguratimod Tablets
Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.
Drug Hydroxychloroquine Sulfate Tablets
Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.

Secondary outcome measures (6)

Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24 [Time frame: 24 weeks]
Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24 [Time frame: 24 weeks]
Change in Schimer's test [Time frame: 24 weeks]
Change in Immunoglobulin G (IgG) concentration [Time frame: 10 and 24 weeks]
Change in serum complements C3 and C4 concentration [Time frame: 10 and 24 weeks]
Change in titer of Rheumatoid Factors [Time frame: 10 and 24 weeks]

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

Chen X, Zhang T, Meng L, Xu C, Jiang L, Wang G, Hou T, Wang H, Han Y, Guan Y, Wang Y, Xue J. Efficacy and safety of iguratimod in patients with primary Sjogren's syndrome: a multicentre randomised controlled trial. RMD Open. 2025 Dec 21;11(4):e006180. doi: 10.1136/rmdopen-2025-006180. PMID 41423293

NCT: NCT04981145 · 2021-0391