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A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Lupus Nephritis Previously Enrolled in Study U2970g

2017年4月10日 更新者:Genentech, Inc.

A Phase III, Extension Study to Evaluate the Safety of Rituximab Retreatment in Subjects With ISN/RPS 2003 Class III or IV Lupus Nephritis Previously Enrolled in Study U2970g

This is a Phase III, multicenter, extension study to evaluate the safety of rituximab administered on a scheduled basis approximately every 6 months. All subjects who complete their Week 52 visit in Study U2970g will be eligible for this study, as long as the inclusion and exclusion criteria are met.

研究概览

地位

撤销

研究类型

介入性

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

16年 至 75年 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Ability and willingness to provide written informed consent and comply with the requirements of the study protocol
  • Participation in Study U2970g and completion of the Week 52 visit in that study
  • For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation

Exclusion Criteria:

  • Discontinuation or withdrawal from Study U2970g or failure to complete the Week 52 visit
  • Any safety concern potentially attributable to rituximab that in the investigator's opinion may jeopardize subject safety
  • In the investigator's opinion, lack of any clinical improvement by Week 52 in Study U2970g and for whom the proposed therapy would represent risk without benefit
  • Current thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
  • Lack of peripheral venous access
  • Pregnancy or lactation
  • History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Significant new or uncontrolled disease in any organ system not related to SLE (e.g., poorly controlled chronic obstructive pulmonary disease or asthma, cardiovascular disease, accelerated hypertension, major depression) that in the investigator's opinion would preclude subject participation
  • Known active infection of any kind (excluding fungal infection of nail beds), any major episode of infection requiring hospitalization, or treatment with IV antibiotics within 4 weeks of a study drug infusion or oral antibiotics within 2 weeks of a study drug infusion
  • History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ
  • Major surgery within 4 weeks prior to screening
  • Intolerance or contraindication to oral or IV corticosteroids
  • Lipase > 2 x the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2.5 x the ULN
  • Amylase levels > 2 x the ULN
  • Absolute neutrophil counts < 1.5 x 10^3/uL
  • History of positive hepatitis B surface antigen or hepatitis C serology
  • Hemoglobin < 7 g/dL unless caused by autoimmune hemolytic anemia resulting from SLE
  • Platelet count < 10,000/uL
  • Receipt of a live vaccine within 28 days prior to treatment

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

研究衡量的是什么?

主要结果指标

结果测量
Safety will be monitored through regular physical examinations, vital signs, hematologic laboratory tests, urinalyses, and incidence and severity of adverse events.

次要结果测量

结果测量
Proportion of subjects who maintain a CRR achieved at Week 52 in Study U2970g
Serum rituximab levels
Circulating B-cell counts.

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:Jay Garg, M.D.、Genentech, Inc.

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。

研究注册日期

首次提交

2006年11月22日

首先提交符合 QC 标准的

2006年11月22日

首次发布 (估计)

2006年11月27日

研究记录更新

最后更新发布 (实际的)

2017年4月12日

上次提交的符合 QC 标准的更新

2017年4月10日

最后验证

2017年4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.

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