Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 468
- 主要终点
- Total Exposure to Etanercept With Gaps
研究概览
简要总结
This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016.0012. The primary objective of this study is to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Previous enrollment in Immunex protocol 016.
- •No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment.
- •Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential.
- •No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc).
排除标准
- •Previous receipt of etanercept (TNFR:Fc) (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein.
- •Receipt of investigational drugs or biologics (other than etanercept (TNFR:Fc)) within interval between study drug in 016.0012 and this study.
- •Receipt of DMARDs (e.g., hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporin, D-penicillamine, sulfasalazine, minocycline, or leflunomide) other than MTX within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
- •Receipt of cyclophosphamide within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.
结局指标
主要结局
Total Exposure to Etanercept With Gaps
时间窗: Up to 8 years
Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.
Total Exposure-Adjusted Rate of Malignancies
时间窗: Up to 8 years
Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
Total Exposure-Adjusted Rate of Deaths
时间窗: Up to 8 years
Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Total Exposure Adjusted Rate of Serious Infectious Events
时间窗: Up to 8 years
Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept
Total Exposure Adjusted Rate of Lymphomas
时间窗: Up to 8 years
Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Malignancy
时间窗: Up to 8 years
Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept
Lymphoma
时间窗: Up to 8 years
Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
Serious Infectious Event
时间窗: Up to 8 years
Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication
Total Exposure Adjusted Rate of Serious Adverse Events
时间窗: Up to 8 years
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure \* 100)
Death
时间窗: Up to 8 years
Death of the participant on study up to 30 days after the last dose of etanercept
次要结局
- ACR20 Response at Month 3(Baseline and month 3)
- Dosing Period(Up to 8 years)
- ACR20 Response at Month 12(Baseline and month 12)
- ACR50 Response at Month 12(Baseline and month 12)
- ACR70 Response at Month 12(Baseline and month 12)
- Standardized Incidence Rate for All SEER Cancers(Up to 8 years)
- Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12(Baseline and month 12)
- Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12(Baseline and Month 12)
- Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12(Baseline and month 12)
- Percent Improvement in Tender Joint Count From Baseline to Month 12(Baseline and month 12)
- Percent Improvement in Swollen Joint Count From Baseline to Month 12(Baseline and month 12)
- Percent Improvement in HAQ DI From Baseline to Month 12(Baseline and month 12)
- Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12(Baseline and month 12)
- Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12(Baseline and month 12)
- Percent Improvement in C-Reactive Protein From Baseline to Month 12(Baseline and month 12)
- Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12(Baseline and month 12)
- Change From Baseline to Year 2 in Total Sharp Score(Baseline, Year 2)
- Change From Baseline to Year 2 in Sharp Score Erosion Subscale(Baseline, Year 2)
- Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale(Baseline, Year 2)