Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
2011年10月28日 更新者：Savient Pharmaceuticals
Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout
This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout.
The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.
研究概览
研究类型
介入性
注册 (实际的)
151
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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San Francisco、California、美国、94118
- Kaiser Permanente Medical Center, Clinical Trials Unit
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Santa Maria、California、美国、93454
- Pacific Arthritis Center Medical Group
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Whittier、California、美国、90606
- Agilence Arthritis & Osteoporosis Medical Center
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District of Columbia
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Washington、District of Columbia、美国、20422
- Veterans Affairs Medical Center
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Florida
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Aventura、Florida、美国、33180
- Arthritis & Rheumatic Disease Specialties
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Ocala、Florida、美国、34474
- Ocala Rheumatology Research Center
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St. Petersburg、Florida、美国、33703
- St. Petersburg Arthritis Center
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Illinois
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Chicago、Illinois、美国、60637
- The University of Chicago
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Kentucky
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Bowling Green、Kentucky、美国、42101
- Graves Gilbert Clinic
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Maryland
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Baltimore、Maryland、美国、21239
- Peter A. Holt, M.D.
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Wheaton、Maryland、美国、20902
- Center for Rheumatology and Bone Research
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Michigan
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Lansing、Michigan、美国、48910
- Justus J. Fiechtner, MD, PC
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Minnesota
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St. Cloud、Minnesota、美国、56377
- CentraCare Clinic
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New Jersey
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Teaneck、New Jersey、美国、07666
- Rheumatology Associates of North Jersey
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North Carolina
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Durham、North Carolina、美国、27302
- Duke University Medical Center
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Ohio
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Cincinnati、Ohio、美国、45242
- New Horizons Clinical Research
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Columbus、Ohio、美国、43210
- The Ohio State University
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Dayton、Ohio、美国、45402
- STAT Research, Inc.
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Mayfield Village、Ohio、美国、44143
- David R. Mandel, MD, Inc.
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Pennsylvania
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Duncansville、Pennsylvania、美国、16635
- Altoona Center for Clinical Research
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Philadelphia、Pennsylvania、美国、19154
- Mid Atlantic Research Assoc.
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Washington
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Spokane、Washington、美国、99204
- Arthritis Northwest, PLLC
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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:
- Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout
Exclusion Criteria:
- unstable angina
- uncontrolled arrhythmia
- uncontrolled hypertension
- end stage renal disease requiring dialysis
- anemia
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：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：q2 RCT
Pegloticase every 2 wk arm of Randomized Controlled Trial(RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study
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8 mg intravenous infusion
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实验性的：q4 RCT
Pegloticase every 4 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study
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8 mg intravenous infusion
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实验性的：Placebo in RCT
Placebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE
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8 mg intravenous infusion
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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 |
|---|---|---|
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Uric Acid (mg/dL)
大体时间：Week 13, Week 25, Week 53, Week 101
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Uric acid measured at 3 month-intervals
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Week 13, Week 25, Week 53, Week 101
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tophus Response
大体时间：Up to 2 years
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Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study.
Results from each participant's final assessment on drug are reported (as last observation carried forward).
Complete response=complete disappearance of at least one tophus with no new or worsening tophus.
Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.
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Up to 2 years
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Patient Reported Outcome: SF-36 Physical Component Summary Score
大体时间：RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101
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SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best). The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status. |
RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101
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Gout Flare Frequency
大体时间：Up to 2 years
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The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment
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Up to 2 years
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Gout Flare Incidence
大体时间：Assessed in 3-month intervals up to 2 years
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Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.
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Assessed in 3-month intervals up to 2 years
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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。
调查人员
- 研究主任：Medical Director, M.D.、Savient Pharmaceuticals, Inc.
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
- Pillinger MH, Fields TR, Yeo AE, Lipsky PE. Dissociation Between Clinical Benefit and Persistent Urate Lowering in Patients with Chronic Refractory Gout Treated with Pegloticase. J Rheumatol. 2020 Apr;47(4):605-612. doi: 10.3899/jrheum.190161. Epub 2019 Jun 15.
- Lipsky PE, Calabrese LH, Kavanaugh A, Sundy JS, Wright D, Wolfson M, Becker MA. Pegloticase immunogenicity: the relationship between efficacy and antibody development in patients treated for refractory chronic gout. Arthritis Res Ther. 2014 Mar 4;16(2):R60. doi: 10.1186/ar4497.
- Baraf HS, Becker MA, Gutierrez-Urena SR, Treadwell EL, Vazquez-Mellado J, Rehrig CD, Ottery FD, Sundy JS, Yood RA. Tophus burden reduction with pegloticase: results from phase 3 randomized trials and open-label extension in patients with chronic gout refractory to conventional therapy. Arthritis Res Ther. 2013 Sep 26;15(5):R137. doi: 10.1186/ar4318.
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
2006年12月1日
初级完成 (实际的)
2010年1月1日
研究完成 (实际的)
2010年1月1日
研究注册日期
首次提交
2008年10月27日
首先提交符合 QC 标准的
2011年5月18日
首次发布 (估计)
2011年5月19日
研究记录更新
最后更新发布 (估计)
2011年12月2日
上次提交的符合 QC 标准的更新
2011年10月28日
最后验证
2011年10月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- C0407
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.