NCT05606107招募中4 期
To Compare the Efficacy and Safety of Low-dose Glucocorticoids and Tofacitinib in Alleviating Moderate to High Disease Activity Rheumatoid Arthritis for 24 Weeks
Second Affiliated Hospital, School of Medicine, Zhejiang University5 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2022年5月20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
- 230
- 试验地点
- 5
- 主要终点
- DAS28-CRP
研究概览
简要总结
Glucocorticoids are effective in the treatment of rheumatoid arthritis, but long-term use of glucocorticoids has many side effects. Tofacitinib is a new small-molecule drug targeting JAK, which has been found to act quickly. The aim of this clinical trial was to investigate the efficacy and safety of tofacitinib and low-dose glucocorticoids in inducing remission in patients with rheumatoid arthritis with moderate to high disease activity.
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
- •Age 18-70 years;
- •met the 2010 ACR and EULAR diagnostic criteria for rheumatoid arthritis (RA), and was diagnosed as RA;
- •After more than 3 months of initial treatment or conventional DMARDs treatment, the disease was still in medium-high disease activity, and DAS28-CRP>3.2;
- •No birth plan during and within 3 months after the end of the study;
- •Voluntarily sign the informed consent form.
排除标准
- •Patients who are using or have used glucocorticoids, tofacitib and biological agents in the past 3 months;
- •At the time of screening, patients were in the acute phase of acute infection or chronic infection;
- •Laboratory test results: Hb<100g/L; White blood cell count <4.0×10^9/L; Platelets <100×10^9/L; Liver function (transaminase, bilirubin)> 2 times the upper limit of normal value; Renal function (SCr) > the upper limit of normal;
- •Active gastrointestinal disease: gastrointestinal bleeding or active gastrointestinal ulcer and acute gastric mucosal injury diagnosed by gastroenteroscopy in the past three months;
- •A history of severe cardiovascular, cerebrovascular, kidney and other important organs, blood and endocrine system lesions, malignant tumors and thrombosis;
- •suffering from serious, progressive and uncontrolled diseases of other important organs and systems;
- •mental disease patients;
- •Other conditions deemed unsuitable for trial participation by the investigator;
- •Pregnancy tests of women of childbearing age were positive.
研究组 & 干预措施
Glucocorticoid group
Active Comparator
干预措施: Glucocorticoid (Drug)
Tofacitinib group
Experimental
干预措施: Tofacitinib (Drug)
结局指标
主要结局
DAS28-CRP
时间窗: 24 weeks
Disease activity
次要结局
未报告次要终点
研究者
研究点 (5)
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