China Rheumatoid Arthritis Registry of Patients With Chinese Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With C-reactive Protein Value (DAS28{CRP}) Remission (DAS28 <2.6) at Month 12
研究概览
简要总结
A multi-center registration study of clinical characteristics of rheumatoid arthritis (RA) patients with Chinese medicine.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Fulfilled the rheumatoid arthritis classification criteria of 2010 American College of Rheumatology (ACR)/the European League Against Rheumatism (EULAR) .
- •Aged 18 years and older.
- •Be willing to accept CM therapies defined as Chinese herbal medicine, Chinese patent medicine, external treatment, acupuncture and moxibustion, etc
排除标准
- •Refuse informed consent.
结局指标
主要结局
Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With C-reactive Protein Value (DAS28{CRP}) Remission (DAS28 <2.6) at Month 12
时间窗: Month 12
DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56\*√(TJC28) +0.28\*√(SJC28)+0.014\*GH+0.36\*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 millimeter \[mm\] visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in \[milligrams/liter\] mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome).
次要结局
- Change From Baseline in DAS28(ESR) at Month 12(Baseline and month 12)
- Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With erythrocyte sedimentation rate (DAS28{ESR}) Remission (DAS28 <2.6) at Month 12(Month 12)
- Title:Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission at All Assessment Time Points(through study completion, once every three months)
- Change From Baseline in DAS28(CRP) at Month 12(Baseline and month 12)
- Change From Baseline in Chinese Patient-reported Activity Index with Rheumatoid Arthritis (CPRI-RA) at All Assessment Time Points(through study completion, once every three months)
- Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points(through study completion, once every three months)
- Percentage of Participants Who Achieved DAS28(ESR) Remission (DAS28 <2.6) at All Time Points(through study completion, once every three months)
- Title:Change From Baseline in DAS28(CRP) at All Assessment Time Points(through study completion, once every three months)
- Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points(through study completion, once every three months)
- Number of Participants With Pulmonary Events(Up to 24 months)
- Title:Change From Baseline in DAS28(ESR) at All Assessment Time Points(through study completion, once every three months)
- Title:Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at All Assessment Time Points(through study completion, once every three months)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at All Assessment Time Points(through study completion, once every three months)
- Participants' sharp score or modified total Sharp score(mTSS) score of wrist bone destruction at All Assessment Time Points(through study completion, once every three months)
- Number of Participants With Hematologic System Events at All Assessment Time Points(through study completion, once every three months)
- Number of Participants With Metabolic Abnormal Events at All Assessment Time Points(through study completion, once every three months)
- Number of Participants With Cardiac Events(Up to 24 months)
研究者
Quan Jiang
MD, PhD, Professor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences