NCT04981145
Recruiting
Phase 4
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study
Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country78 target enrollmentStarted: January 14, 2022Last updated:
ConditionsPrimary Sjögren's Syndrome
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- The change of SSRI-30 between the two groups at 24 weeks
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
IGU Group
Experimental
Intervention: Iguratimod Tablets (Drug)
HCQ Group
Active Comparator
Intervention: Hydroxychloroquine Sulfate Tablets (Drug)
Outcomes
Primary Outcomes
The change of SSRI-30 between the two groups at 24 weeks
Time Frame: 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
Secondary Outcomes
- Change in Schimer's test(24 weeks)
- Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24(24 weeks)
- Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24(24 weeks)
- Change in Immunoglobulin G (IgG) concentration(10 and 24 weeks)
- Change in serum complements C3 and C4 concentration(10 and 24 weeks)
- Change in titer of Rheumatoid Factors(10 and 24 weeks)
Investigators
Study Sites (1)
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