Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
2013年5月10日 更新者：Amgen
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.
研究概览
研究类型
介入性
注册 (实际的)
468
阶段
- 第三阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria: - Previous enrollment in Immunex protocol 016.0012.
- 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). Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：1个
|
Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Exposure to Etanercept With Gaps
大体时间：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.
|
Up to 8 years
|
|
Total Exposure-Adjusted Rate of Malignancies
大体时间：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
|
Up to 8 years
|
|
Total Exposure-Adjusted Rate of Deaths
大体时间：Up to 8 years
|
Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
|
Up to 8 years
|
|
Total Exposure Adjusted Rate of Serious Infectious Events
大体时间：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
|
Up to 8 years
|
|
Total Exposure Adjusted Rate of Lymphomas
大体时间：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
|
Up to 8 years
|
|
Malignancy
大体时间：Up to 8 years
|
Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept
|
Up to 8 years
|
|
Lymphoma
大体时间：Up to 8 years
|
Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
|
Up to 8 years
|
|
Serious Infectious Event
大体时间：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
|
Up to 8 years
|
|
Total Exposure Adjusted Rate of Serious Adverse Events
大体时间：Up to 8 years
|
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
|
Up to 8 years
|
|
Death
大体时间：Up to 8 years
|
Death of the participant on study up to 30 days after the last dose of etanercept
|
Up to 8 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
ACR20 Response at Month 3
大体时间：Baseline and month 3
|
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)
|
Baseline and month 3
|
|
Dosing Period
大体时间：Up to 8 years
|
Duration of etanercept dosing
|
Up to 8 years
|
|
ACR20 Response at Month 12
大体时间：Baseline and month 12
|
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults
|
Baseline and month 12
|
|
ACR50 Response at Month 12
大体时间：Baseline and month 12
|
American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults
|
Baseline and month 12
|
|
ACR70 Response at Month 12
大体时间：Baseline and month 12
|
American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults
|
Baseline and month 12
|
|
Standardized Incidence Rate for All SEER Cancers
大体时间：Up to 8 years
|
Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer.
Expected rates were based on 1998-2002 SEER data.
|
Up to 8 years
|
|
Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12
大体时间：Baseline and month 12
|
Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
|
Baseline and month 12
|
|
Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12
大体时间：Baseline and Month 12
|
Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
|
Baseline and Month 12
|
|
Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12
大体时间：Baseline and month 12
|
Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from "no pain" (0 cm) to "severe pain" (10 cm).
|
Baseline and month 12
|
|
Percent Improvement in Tender Joint Count From Baseline to Month 12
大体时间：Baseline and month 12
|
Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.
|
Baseline and month 12
|
|
Percent Improvement in Swollen Joint Count From Baseline to Month 12
大体时间：Baseline and month 12
|
Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.
|
Baseline and month 12
|
|
Percent Improvement in HAQ DI From Baseline to Month 12
大体时间：Baseline and month 12
|
Percent improvement in the Health Assessment Questionnaire Disability Index (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
大体时间：Baseline and month 12
|
Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12.
This score has a range of 0 to 100, with higher scores indicating better health.
|
Baseline and month 12
|
|
Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12
大体时间：Baseline and month 12
|
Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12.
This score has a range of 0 to 100, with higher scores indicating better health.
|
Baseline and month 12
|
|
Percent Improvement in C-Reactive Protein From Baseline to Month 12
大体时间：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
大体时间：Baseline and month 12
|
Percent improvement in the duration of morning stiffness from baseline to month 12
|
Baseline and month 12
|
|
Change From Baseline to Year 2 in Total Sharp Score
大体时间：Baseline, Year 2
|
Change from baseline to year 2 in Total Sharp Score.
This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.
|
Baseline, Year 2
|
|
Change From Baseline to Year 2 in Sharp Score Erosion Subscale
大体时间：Baseline, Year 2
|
Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score.
This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.
|
Baseline, Year 2
|
|
Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale
大体时间：Baseline, Year 2
|
Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score.
This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.
|
Baseline, Year 2
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Weinblatt ME, Bathon JM, Kremer JM, Fleischmann RM, Schiff MH, Martin RW, Baumgartner SW, Park GS, Mancini EL, Genovese MC. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken). 2011 Mar;63(3):373-82. doi: 10.1002/acr.20372. Epub 2010 Oct 18.
- Genovese MC, Bathon JM, Fleischmann RM, Moreland LW, Martin RW, Whitmore JB, Tsuji WH, Leff JA. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol. 2005 Jul;32(7):1232-42.
- Genovese MC, Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, Wasko MC, Moreland LW, Weaver AL, Markenson J, Cannon GW, Spencer-Green G, Finck BK. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. 2002 Jun;46(6):1443-50. doi: 10.1002/art.10308.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
1998年12月1日
初级完成 (实际的)
2008年12月1日
研究完成 (实际的)
2009年4月1日
研究注册日期
首次提交
2006年7月24日
首先提交符合 QC 标准的
2006年7月24日
首次发布 (估计)
2006年7月26日
研究记录更新
最后更新发布 (估计)
2013年5月14日
上次提交的符合 QC 标准的更新
2013年5月10日
最后验证
2013年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.