NCT04830644Unknown2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Iguratimod in Patients With Active Primary Sjogren's Syndrome.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 144
- 试验地点
- 30
- 主要终点
- Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of iguratimod compared to placebo in patients with active primary Sjogren'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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjogren's Syndrome (EULAR SS)
- •ESSDAI score ≥6
- •IgG >16 g/L
- •Positive anti-SS-A/Ro antibody at screening
排除标准
- •Pregnancy or breast feeding
- •Secondary Sjogren's syndrome
- •severe renal or haematological failure, a history of cancer, hepatitis B or C, human immunodeficiency virus, severe diabetes or any other chronic disease or evidence of infection
- •Prior administration of any of the following:
- •Rituximab in the past 12 months prior to randomization;
- •Cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide and iguratimod in the past 12 weeks prior to randomization;
- •Azathioprine, cyclosporin, tacrolimus, sirolimus, sulfasalazine in the past 4 weeks prior to randomization;
- •live vaccine in the past 12 weeks prior to randomization
- •Corticosteroids: > 10 mg/day oral prednisone (or equivalent); Any change or initiation of new dose within 4 weeks prior to randomization; Intramuscular, subcutaneous, intravenous, or intra-articular corticosteroids within 4 weeks prior to randomization.
研究组 & 干预措施
Iguratimod 1
Experimental
orally 25mg twice a day
干预措施: Iguratimod (Drug)
Iguratimod 2
Experimental
orally 20mg twice a day
干预措施: Iguratimod (Drug)
Iguratimod 3
Experimental
orally 10mg twice a day
干预措施: Iguratimod (Drug)
Placebo
Placebo Comparator
orally twice a day
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
时间窗: Week 12
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. Overall score, which can range from 0 to 123, a higher score indicates more disease activity
次要结局
- Change From Baseline in the level of B -cell activation factor (BAFF)(Week 12)
- Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)(Week 12)
- Change From Baseline in the level of immunoglobulin (IgG, IgA, IgM)(Week 12)
- Change From Baseline in the level of T/B/NK cell subsets(Week 12)
- Change From Baseline in the Unstimulated Salivary Flow(Week 12)
- Change From Baseline in Schirmer's Test(Week 12)
- Change From Baseline in the level of rheumatoid factor (RF)(Week 12)
- Change From Baseline in the level of erythrocyte sedimentation rate (ESR)(Week 12)
- Change From Baseline in the level of serum complement (C3 and C4)(Week 12)
研究者
研究点 (30)
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