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

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

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

Conditions
-----------------
Primary Sjögren's Syndrome

Intervention / Treatment
-----------------
* Drug: Iguratimod Tablets
* Drug: Hydroxychloroquine Sulfate Tablets


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IGU Group<br> | Drug: Iguratimod Tablets<br>* Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.<br>|
| Active Comparator: HCQ Group<br> | Drug: Hydroxychloroquine Sulfate Tablets<br>* Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of SSRI-30 between the two groups at 24 weeks | SS Responder Index (SSRI) is a composite endpoint, investigators defined an SSRI-30 response as a ≥30% improvement in at least two of five outcome measures (patient-assessed visual analogue scale scores for fatigue, oral dryness and ocular dryness, unstimulated whole salivary flow and ESR at 24 weeks | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24 | The ESSPRI is composed of 3 scales - dryness, fatigue, and pain. Each scale is measured 0 - 10, 0 being no symptoms, 10 being maximal imaginable dryness, fatigue or pain. The total score is the mean score of the three scales. Baseline ESSPRI total score will be compared to week 24, end of treatment, ESSPRI total score. | 24 weeks | 
| Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24 | The ESSDAI is a disease activity measurement that has 12 domains. The score of each domain is the product of the weight of the domain by the level of activity. Activity levels are 0 - 3, 0 being no activity, 3 being high activity. The total score is the sum of the score of all domains. Change in total score from BL to week 24 will be measured. | 24 weeks | 
| Change in Schimer's test | The change from baseline in Schimer's test at 24 weeks. The Schirmer's test assesses tear secretion. | 24 weeks | 
| Change in Immunoglobulin G (IgG) concentration | The change from baseline in IgG concentration at 10 and 24 weeks. | 10 and 24 weeks | 
| Change in serum complements C3 and C4 concentration | The change from baseline in serum complements C3 and C4 concentrationat 10 and 24 weeks. | 10 and 24 weeks | 
| Change in titer of Rheumatoid Factors | The change from baseline in titer of rheumatoid factors at 10 and 24 weeks. | 10 and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Sjögren's syndrome, Sjögren's syndrome, Iguratimod