Tripterygium Wilfordii Hook F and Methotrexate for Postmenopausal Women With Rheumatoid Arthritis: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percentage of ACR20
研究概览
简要总结
This study is a multicenter, randomized, double-blinded, controlled trial with two parallel arms. The aim of the study is to evaluate whether Tripterygium wilfordii Hook F combined with methotrexate (MTX) might be better than MTX alone for postmenopausal women with active rheumatoid arthritis (RA).
详细描述
To compare the efficacy and safety of Tripterygium wilfordii Hook F (TwHF) and methotrexate (MTX) for postmenopausal women with active rheumatoid arthritis (RA), a multicenter, randomized controlled trial will be conducted. Three hundred postmenopausal women with active RA will be randomly allocated (1:1) to treatment with TwHF 20mg thrice daily and MTX 10 mg once a week for 24 weeks, or MTX plus dummy TwHF. The primary outcome is the percentage of participants with American College of Rheumatology 20% at week 24.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •postmenopausal women, postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy;
- •diagnosed with RA as determined by meeting the 2010 ACR/EULAR classification criteria and having had RA for at least 6 weeks;
- •active disease at the time of enrollment as indicated by 28-joint Disease Activity Score (DAS28) greater than 3.2;
- •no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.
排除标准
- •RA combined with other autoimmune disease, such as adjuvant arthritis, lupus arthritis, or osteoarthritis;
- •RA combined with abnormal liver and kidney function;
- •severe chronic or acute disease interfering with attendance for therapy;
- •patients who had received DMARDs or biological therapy within one months before participating in this study.
研究组 & 干预措施
Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX)
Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
干预措施: Tripterygium wilfordii Hook F (TwHF) (Drug)
Tripterygium wilfordii Hook F (TwHF) plus methotrexate (MTX)
Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
干预措施: Methotrexate (Drug)
TwHF (dummy) plus MTX
Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
干预措施: Methotrexate (Drug)
TwHF (dummy) plus MTX
Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks. Oral methotrexate 10 mg per week for 24 weeks.
干预措施: Dummy Tripterygium wilfordii Hook F (TwHF) (Other)
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
- Mean 24-week Change in Disease Activity Score Based on 28-Joint Count (DAS28)(week 24)
- Change From Baseline in Modified Total Sharp X-Ray Score at Week 24(week 24)
- Patient Reported Outcomes (PRO)(week 24)
- Percentage of ACR50(week 24)
- Percentage of ACR70(week 24)
- RAMRIS score(week 24)
研究者
Quan Jiang
Guang'anmen Hospital
Guang'anmen Hospital of China Academy of Chinese Medical Sciences