A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Rheumatoid Arthritis and Inadequate Response to Treatment With Methotrexate
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 647
- 试验地点
- 141
- 主要终点
- ACR-20 - 20% Improvement According to American College of Rheumatology Criteria
研究概览
简要总结
This is a two part study comparing CHS-0214 to Enbrel in patients with active rheumatoid arthritis and an inadequate response with Methotrexate (MTX) who are naive to biologic therapies.
Pt.1 is a 24-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 20% improvement in American College of Rheumatology criteria (ACR-20) at week 24. Comparing CHS-0214 to Enbrel for efficacy and safety.
Pt. 2 is an open-label single arm study in which patients with at least an ACR-20 response receive CHS-0214. Continued response and safety will be evaluated.
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
- •Male or female adults
- •RA (Rheumatoid Arthritis) diagnosis for 6 months
- •On stable dose of MTX of 8mg to 25mg per week
- •Active disease: greater than 6 tender joints, greater than 6 swollen joints, C-reactive protein (CRP) greater than or equal to 0.5mg/dL, and disease activity score (DAS) with 28 joints (DAS28-CRP(4)) greater than or equal to 3.2
排除标准
- •Use of prednisone greater than 10mg/day
- •Use of greater than one non-steroidal anti-inflammatory drug (NSAID)
- •Use of biologic therapies for any cause
- •Chemistry and hematology values outside protocol specified range
- •Positive QuantiFERON-tuberculosis (TB) Gold Test
- •Evidence of active lung disease on chest x-ray
- •Major systemic infections
- •Presence of significant comorbid conditions
- •Known allergy to latex
- •Women who are pregnant or nursing
研究组 & 干预措施
Enbrel (etanercept)
Enbrel 50mg weekly times 24 weeks.
干预措施: Etanercept (Drug)
CHS-0214
CHS-0214 50mg weekly times 24 weeks.
干预措施: CHS-0214 (Drug)
结局指标
主要结局
ACR-20 - 20% Improvement According to American College of Rheumatology Criteria
时间窗: 24-weeks
The primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the following 5 measures: high sensitivity C reactive protein(hs-CRP), Health Assessment Questionnaire Disability Index(HAQ-DI), subjects global assessment of pain(SPA, VAS), subject's global assessment of disease activity(SGA-VAS), physician's global assessment of disease activity(PGA-VAS)
次要结局
- Summary of Change in Tender Joint Count (TJC) by Study Visit(Weeks 4,8,12,18,24,28,36,48)
- ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18(Weeks 4, 8, 12 and 18)
- Summary of Change in Swollen Joint Count (SJC) by Study Visit(Weeks 4,8,12,18,24,28,36,48)
- Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit(Weeks 4,8,12,18,24,28,36,48)
- Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit(Weeks 4,8,12,18,24,28,36,48)
- Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit(Weeks 4,8,12,18,24,28,36,48)