Efficacy of Chinese Herbal Medicine Qing Re Huo Xue in Patients With Rheumatoid Arthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Change in bone marrow edema score from baseline at week 24 in OMERACT RAMRIS
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 Chinese herbal medicine Qing Re Huo Xue (QRHX) combined with methotrexate (MTX) might be better than MTX alone for patients with active rheumatoid arthritis (RA).
详细描述
To compare the efficacy and safety of Chinese herbal medicine Qing Re Huo Xue (QRHX) and methotrexate (MTX) for patients with active rheumatoid arthritis (RA), a multicenter, randomized controlled trial will be conducted. Two hundred and four patients with active RA will be randomly allocated (1:1) to treatment with QRHX 10mg bid and MTX 10 mg once a week for 24 weeks, or MTX plus dummy QRHX. The primary outcome is he OMERACT rheumatoid arthritis MRI scoring system (RAMRIS) 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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has had a confirmed diagnosis of rheumatoid arthritis according to 2010 ACR/EULAR RA classification criteria.
- •Subject has a DAS28 CRP disease activity score of >3.2 at screening.
- •Subject also experienced the following signs and symptoms: swelling, joint pain, and heat in the joints.
- •Subject has had no prior exposure to oral glucocorticoids at a daily dose greater than 10 mg or to any biologic agents.
- •Subject may has had previous exposure to nonsteroidal anti-inflammatory drugs (NSAIDs) prior to screening and must be on stable dose.
排除标准
- •History or presence of a clinically significant medical disorder other than RA that, in the opinion of the investigator and medical monitor, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- •Subject has inflammatory, rheumatological disorders other than RA, where arthritis may be a prominent feature.
- •Subject has received treatment with the prohibited therapies listed in the protocol, or changes to those treatments, within the prescribed timeframe.
- •Pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant.
研究组 & 干预措施
Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX)
QRHX granule 10g bid and methotrexate (MTX) 10 mg once a week for 24 weeks
干预措施: Qing Re Huo Xue (QRHX) granule (Drug)
Qing Re Huo Xue (QRHX) granule plus methotrexate (MTX)
QRHX granule 10g bid and methotrexate (MTX) 10 mg once a week for 24 weeks
干预措施: Methotrexate (Drug)
Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX)
QRHX granule placebo 10g bid plus Methotrexate (MTX) 10mg once a week for 24 weeks
干预措施: Methotrexate (Drug)
Qing Re Huo Xue (QRHX) granule placebo plus Methotrexate (MTX)
QRHX granule placebo 10g bid plus Methotrexate (MTX) 10mg once a week for 24 weeks
干预措施: Qing Re Huo Xue (QRHX) granule placebo (Drug)
结局指标
主要结局
Change in bone marrow edema score from baseline at week 24 in OMERACT RAMRIS
时间窗: week 0, week 24
Bone marrow edema score will be assessed by OMERACT-RAMRIS scoring system; minimum value: 0, maximum value: 75; higher scores mean a worse outcome.
次要结局
- Change in bone erosion score from baseline at week 24 in OMERACT RAMRIS(week 0, week 24)
- The proportion of participants with no progression in bone marrow edema and bone erosion(week 24)
- The proportion of participants achieving ACR response (ACR20, ACR50, ACR70)(week 4, week 12, week 24)
- Change in the 28-joint Disease Activity Score in erythrocyte sedimentation rate(week 0, week 4, week 12, week 24)
- Change in Clinical Disease Activity Index (CDAI)(week0, week4, week 12, week 24)
- Change in Chinese patient-reported activity index with rheumatoid arthritis (CPRI-RA)(week0, week 4, week 12, week 24)
- Change in Health Assessment Questionnaire Disability Index (HAQ-DI)(week0, week4, week 12, week 24)
研究者
Quan Jiang
chief physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences