Evaluating Iguratimod for treating 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

This study is testing if Iguratimod can help people with Primary Sjögren's Syndrome feel better by reducing symptoms like dry mouth and eyes.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04981145 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, prospective, open-label, randomized controlled study aimed at assessing the efficacy and safety of Iguratimod in patients diagnosed with Primary Sjögren's Syndrome. Participants will receive Iguratimod tablets and will be monitored for improvements in symptoms such as dry mouth and eyes. The study will include patients who meet specific diagnostic criteria and have not received certain treatments prior to enrollment. The trial aims to provide valuable data on the effectiveness of Iguratimod compared to standard treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with Primary Sjögren's Syndrome who experience symptoms like dry mouth and eyes.

Not a fit: Patients with other connective tissue diseases, malignancies, or those who have recently participated in other drug trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for patients suffering from Primary Sjögren's Syndrome.

How similar studies have performed: Other studies have explored treatments for Primary Sjögren's Syndrome, but the specific use of Iguratimod in this context is relatively novel.

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

Where this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Principal investigator: Yongmei Han — Sir Run Run Shaw Hospital
• Study coordinator: Jing Xue

Conditions: Primary Sjögren's Syndrome, Primary Sjögren's syndrome, Sjögren's syndrome, Iguratimod