Efficacy and Safety of Colquhounia Root Tablet in Patients With Rheumatoid Arthritis：A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Percentage of ACR20
研究概览
简要总结
This study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Colquhounia Root Tablet combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject understood the whole process of the trial and signed the informed consent voluntarily.
- •Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
- •Subjects aged between 45-70years who were the males without fertility requirements or menopausal women.
- •Subject has a DAS28 CRP disease activity score greater than 2.6 and less than 5.
- •Subject did not participate in any drug trials within 1 month before enrollment.
排除标准
- •Pregnant women, women planning to become pregnant or breastfeeding.
- •Severe systemic involvement, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, autoimmune liver disease.
- •Active liver disease or abnormal liver function, ALT and AST are more than 1.5 times the upper limit of normal.
- •Renal impairment, serum creatinine greater than the upper limit of normal.
- •Bone marrow hematopoietic dysfunction, peripheral blood leukocytes <3.0×109/L, or definite anemia (hemoglobin less than 80g/L), or platelets <80×109/L, or other blood system diseases.
- •Active gastric and duodenal ulcers.
- •Uncontrolled severe hypertension, metabolic diseases.
- •malignant tumors.
- •Acute and/or chronic infectious diseases.
- •Severe cardiac arrhythmia found on electrocardiogram.
- •Mental illness, history of alcoholism, drug or other substance abuse.
- •Diagnosed with other connective tissue disease.
- •Those who have used immunosuppressants, biological agents, Colquhounia Root Tablet or drugs containing Tripterygium wilfordii within 1 month before enrollment.
- •Those who have previously used methotrexate or preparations containing tripterygium wilfordii for 12 weeks or more ,but their condition is not under control.
- •Adverse reactions have occurred in the past using Colquhounia Root Tablet or drugs containing Tripterygium wilfordii.
研究组 & 干预措施
Colquhounia Root Tablet plus methotrexate (MTX)
Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks.
干预措施: Colquhounia Root Tablet (Drug)
Colquhounia Root Tablet plus methotrexate (MTX)
Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks.
干预措施: Methotrexate tablets (Drug)
placedo of Colquhounia Root Tablet plus methotrexate (MTX)
placedo of Colquhounia Root Tablet 0.9g tid and methotrexate (MTX) 10 mg oncea week for the first 12 weeks，placedo of Colquhounia Root Tablet 0.54g tid and methotrexate (MTX) 10 mg once a week for the after 12 weeks.
干预措施: Methotrexate tablets (Drug)
结局指标
主要结局
Percentage of ACR20
时间窗: week 24
Percentage of Participants With American College of Rheumatology 20% (ACR20)
次要结局
- Percentage of ACR70(week 24)
- Percentage of ACR50(week 24)
- DAS28-ESR(week 24)
- Chinese Patient-reported Activity Index with RA scale (PRO)(week 24)
研究者
Quan Jiang
chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences