A Randomized,Placebo Controlled, Double-blind, Parallel Group, Phase II Study to Evaluate the Efficacy and Safety of SM03, Compared to Placebo, in Patients With Moderate-to-Severe Active Rheumatoid Arthritis Receiving Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
研究概览
简要总结
This study evaluated the safety and efficacy of SM03 compared to placebo in patients with active rheumatoid arthritis(RA) receiving methotrexate
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18-75 years of age.
- •Rheumatoid arthritis (RA) for ≥ 12 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
- •Moderate to severe active RA with swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
- •At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes
- •Inadequate response to methotrexate, having received and tolerated at a dose of 7.5-20 mg/week for ≥ 12 weeks, at a stable dose over the past 4 weeks.
排除标准
- •Rheumatic autoimmune disease other than RA.
- •Use of any biological DMARDs for RA within past 6 months.
- •Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
- •Active infection, or history of serious or chronic infection
研究组 & 干预措施
SM03 600 mg*2
SM03: 600 mg intravenous (IV) on week 0,2, and week 12,14; placebo: 600 mg intravenous (IV) on week 4 and16; Methotrexate: 7.5-20 mg/wk oral.
干预措施: Methotrexate (Drug)
SM03 600 mg*2
SM03: 600 mg intravenous (IV) on week 0,2, and week 12,14; placebo: 600 mg intravenous (IV) on week 4 and16; Methotrexate: 7.5-20 mg/wk oral.
干预措施: SM03 (Drug)
SM03 600 mg*2
SM03: 600 mg intravenous (IV) on week 0,2, and week 12,14; placebo: 600 mg intravenous (IV) on week 4 and16; Methotrexate: 7.5-20 mg/wk oral.
干预措施: Placebo (Drug)
SM03 600 mg*3
SM03: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16; Methotrexate: 7.5-20 mg/wk oral.
干预措施: SM03 (Drug)
SM03 600 mg*3
SM03: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16; Methotrexate: 7.5-20 mg/wk oral.
干预措施: Methotrexate (Drug)
placebo*3
placebo: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16; Methotrexate: 7.5-20 mg/wk oral.
干预措施: Placebo (Drug)
placebo*3
placebo: 600 mg intravenous (IV) on week 0,2, 4, and week 12,14,16; Methotrexate: 7.5-20 mg/wk oral.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24
时间窗: Week 24
To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements: * Physician's global assessment of disease activity (assessed using a 10 cm Visual Analog Scale \[VAS\]); * Patient's global assessment of disease activity (assessed using a 10 cm VAS); * Patient's assessment of pain (assessed using a 10 cm VAS); * Health Assessment Questionnaire (HAQ; a patient completed questionnaire consisting of 20 questions, scored from 0-3); * Acute phase reactant: C-reactive protein (CRP)
次要结局
- Percentage of Participants With Adverse Events(Week 0 to 24)
- Percentage of Participants With an ACR70 Response at Week 24(Week 24)
- Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24(Baseline and Week 24)
- Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24(Week 24)
- Percentage of Participants With an ACR50 Response at Week 24(Week 24)
- Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 4,8,12, 16(Week 4,8,12,16)