A 24-Week, Multicenter ,Double Blind, Randomized Study to Determine the Effects and Security of TwHF and MTX Treating Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 入组人数
- 216
- 主要终点
- The change from Baseline to week 24 in Disease Activity Score (DAS28)
研究概览
简要总结
Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of rheumatoid arthritis (RA).
详细描述
Two arms were included in this study. Active Comparator: treatment of MTX Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental: treatment of TwHF Patients were treated with methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF).
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
- Double (Participant, Investigator)
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
- •Diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 ACR classification criteria;
- •No male or female fertility requirements, or around menopause women;
- •Patients with mild-to-moderate activity, 2.6 < DAS28≤5.1;
- •No serious system involved, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc;
- •Within a month before the selected participants did not attend any drugs
排除标准
- •Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
- •Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
- •Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
- •Previous treated with Tripterygium Wilfordii or MTX
- •Patients with retinopathy.
研究组 & 干预措施
Treatment of MTX
Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.
干预措施: Treatment of MTX (Drug)
Treatment of MTX and TwHF
Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF).
干预措施: Treatment of MTX and TwHF (Drug)
结局指标
主要结局
The change from Baseline to week 24 in Disease Activity Score (DAS28)
时间窗: 0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks
Disease Activity Score for 28-joint counts was based on the erythrocyte sedimentation rate(ESR) (DAS28-4\[ESR\])
次要结局
- The proportion of patients achieving ACR20/50/70(0 weeks, 4 weeks，12 weeks, 24 weeks)
- The change in Health Assessment Questionnaire (HAQ) score(0 weeks, 4 weeks，12 weeks, 24 weeks,52 weeks)
- The change in Sharp score(0 week,24 weeks,52 weeks)
- The number of adverse events(24 weeks)
研究者
Quan Jiang
director
Guang'anmen Hospital of China Academy of Chinese Medical Sciences