Study of Iguratimod in Sjögren's Syndrome

Study Overview
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Brief Summary
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A single-center, self-control, open-label study of efficacy and safety of Iguratimod in patients with Sjögren's Syndrome

Detailed Description
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In this study, patients with Sjögren's Syndrome are enrolled and received Iguratimod 25 mg twice a day for 24 weeks. The differences of ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score, ESSPRI(EULAR Sjogren's Syndrome Patient Reported Index) score, unstimulated salivary flow rate, Schirmer's test SF-36 score and HAQ score between baseline and week 24 are evaluated to determine the efficacy of Iguratimod in patients with Sjögren's Syndrome.

Official Title
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A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Drug: Iguratimod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria Positive dry eyes and (or) dry mouth symptoms Hyperglobulinemia Exclusion Criteria: Complicated with other systemic autoimmune diseases Severe complications of Sjogren's syndrome Glucocorticosteroid therapy, systemic immunosuppressant therapy, or biological agents therapy within 3 months prior to the screening visit Active infections or chronic infectious diseases A history of malignancies Pregnancy or breathfeeding Inability to comply with the study protocol for any other reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iguratimod<br>Patients are treated with Iguratimod 25 mg Twice a day for 24 weeks. | Drug: Iguratimod<br>* Iguratimod 25 mg orally twice a day for 24 weeks<br>* Other names: T-614;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ESSDAI improvement | The change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score at 24 weeks. | week 24 | 
| ESSPRI improvement | The change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score at 24 weeks. | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 | The change from baseline in SF-36 score at 24 weeks. | week 24 | 
| HAQ | The change from baseline in HAQ score at 24 weeks. | week 24 | 
| Immunoglobulins | The change from baseline in IgG, IgM and IgA levels at 24 weeks. | week 24 | 
| Rheumatoid Factors | The change from baseline in titer of rheumatoid factors at 24 weeks. | week 24 | 
| Unstimulated salivary flow rate | The change from baseline in unstimulated salivary flow rate at 24 weeks. | week 24 | 
| Schimer's test | The change from baseline in Schimer's test at 24 weeks. | week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjogren's Syndrome, Iguratimod