NCT04981145招募中4 期
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 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2022年1月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- The change of SSRI-30 between the two groups at 24 weeks
研究概览
简要总结
A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
IGU Group
Experimental
干预措施: Iguratimod Tablets (Drug)
HCQ Group
Active Comparator
干预措施: Hydroxychloroquine Sulfate Tablets (Drug)
结局指标
主要结局
The change of SSRI-30 between the two groups at 24 weeks
时间窗: 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
次要结局
- 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)
研究者
研究点 (1)
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