A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 188
- 试验地点
- 61
- 主要终点
- Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12
研究概览
简要总结
Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.
- •Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.
排除标准
- •Prior treatment with etanercept.
- •Presence of active infection or active or untreated tuberculosis.
结局指标
主要结局
Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12
时间窗: Week 12
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24
时间窗: Week 24
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment
时间窗: Baseline up to Week 24
Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.
次要结局
- Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment(Baseline (Day 1) up to Week 24)
- Number of Participants With Investigator-Identified Serious Infections(Baseline (Day 1) up to Week 28 (Follow-up))
- Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities(Baseline (Day 1) up to Week 28 (Follow-up))
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline (Day 1) up to Week 28 (Follow-up))
- Number of Participants With Injection Site Reactions(Baseline (Day 1) up to Week 28 (Follow-up))
- Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response(Week 4, 12, 24)
- Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response(Week 4, 12, 24)
- Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response(Week 4, 12, 24)
- Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24(Baseline, Week 4, 12, 24)
- Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24(Baseline, Week 4, 12, 24)
- Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24(Baseline, Week 4, 12, 24)