NCT04515706Unknown不适用
Safety, Tolerability, Efficacy of Iguratimod in Systemic Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.
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
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of systemic sclerosis (SSc), as classified using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc.
- •Diffuse Cutaneous Systemic Sclerosis (dcSSc) as defined by 2001 LeRoy and Medsger Disease duration ≤ 3 years (defined as time from the first non-Raynaud phenomenon manifestation).
- •Agree to use effective contraception during the study period (women of childbearing age).
- •Smokers agreed to quit smoking during the study.
- •Ability to provide informed consent.
排除标准
- •The following drugs have been used within one month before screening: including TNF-α inhibitors (continuous use for more than 14 days), IL-6 inhibitors, abatacept (continuous use for more than 14 days), JAK inhibitors (continuous use for more than 14 days).
- •Used rituximab within 3 months before screening.
- •SSc with tumor.
- •People with various lung infections, asthma or other lung diseases such as bronchiectasis.
- •For patients with severe heart, liver, kidney and other important organ dysfunction, the evaluation criteria are as follows: ALT or AST is greater than 2 times the upper limit of normal, or total bilirubin rises twice; CPK>400; Renal crisis, or hypertension of various causes (≥160/100mmHg) is not controlled; Creatinine clearance rate <30ml/min; White blood cell count<3×109/L; Hemoglobin <80g/L; Platelet count<60×109/L; Heart function level III-IV; PaO2<50mmHg in resting state; FEV1/FVC<0.
- •In the period of acute or chronic infection (not including finger ulcer combined infection).
- •A history of peptic ulcer or bleeding within 6 months before screening.
- •People with allergies or multiple drug allergies.
- •People with mental illness or other reasons who cannot cooperate with treatment.
研究组 & 干预措施
Iguratimod
Experimental
Iguratimod 25 twice a day (bid) on Week 1-48.
干预措施: Iguratimod (Drug)
Placebo
Placebo Comparator
Placebo twice a day (bid) on Week 1-24, and Iguratimod 25 twice a day (bid) on Week 25-48.
干预措施: Iguratimod (Drug)
Placebo
Placebo Comparator
Placebo twice a day (bid) on Week 1-24, and Iguratimod 25 twice a day (bid) on Week 25-48.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24
时间窗: Week 24
Primary outcome is met if any participants experience a grade 3 or higher event prior to Week 24. A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03.
次要结局
- Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study(Week 12, 24, 36, and 48)
- Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study(Week 12, 24, 36, and 48)
- Change in Modified Rodnan Skin Score (mRSS)(Week 12, 24, 36, and 48)
- Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis(Week 12, 24, and 48)
- Scleroderma Clinical Trials Consortium Damage Index(Week 24, 48)
- Change in Skin Thickness(Week 24, 48)
研究者
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