Open-Label Extension Treatment With Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) for Participating Patients in Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) Clinical Trials
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 639
- 主要终点
- Total Exposure to Etanercept With Gaps
研究概览
简要总结
This study was designed to provide all adult and pediatric arthritis patients (placebo and etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The primary objective of this study is to examine safety parameters.
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
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous enrollment in Immunex protocols
- •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 TNFR:Fc (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein.
- •Receipt of investigational drugs or biologics (other than TNFR:Fc [p75]) within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.
- •Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
- •Receipt of cyclophosphamide within six months prior to the first dose of (etanercept (TNFR:Fc) in this study.
- •Receipt of cyclosporin within two weeks 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 10 years
Total participant exposure to etanercept (Enbrel) with gaps
Total Exposure Adjusted Rate of Deaths
时间窗: Up to 10 years
Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Lymphoma
时间窗: Up to 10 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 10 years
Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication. A serious infectious event is a serious adverse event that is infectious.
Total Exposure Adjusted Rate of Malignancies
时间窗: Up to 10 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 Serious Infectious Events
时间窗: Up to 10 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 10 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 10 years
Occurrence of one or more malignancies on study within 30 days of the last dose of etanercept
Death
时间窗: Up to 10 years
Occurrence of death on study within 30 days of the last dose of etanercept
Total Exposure Adjusted Rate of Serious Adverse Events
时间窗: Up to 10 years
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure \* 100)
次要结局
- Standardized Incidence Rate for All SEER Cancers(up to 10 years)
- Swollen Joint Count(Month 12)
- Childhood Health Assessment Questionnaire(Month 12)
- Dosing Period(Up to 10 years)
- C-Reactive Protein(Month 12)
- Health Assessment Questionnaire Disability Index(Month 12)
- ACR20 at Month 3 in Adults(Baseline and month 3)
- Tender Joint Count(Month 12)
- JRA DOI 30 at Month 3 in Juveniles(Baseline and month 3)