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Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Patients With Plaque Psoriasis

2016年11月2日 更新者：Amgen

A Single-arm Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Subjects With Plaque Psoriasis

The purpose of this study is to learn more about the immune response to etanercept produced using a modified process in patients with plaque psoriasis.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a multicenter, open-label, single-arm phase 4 study in patients with plaque psoriasis who are etanercept-naïve and who are not receiving methotrexate therapy. The study will consist of a screening period of up to 30 days, a 24-week treatment period and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for patients with plaque psoriasis.

研究类型

介入性

注册 (实际的)

132

阶段

  • 第四阶段

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

  • 加拿大
    • British Columbia
      • Surrey、British Columbia、加拿大、V3R 6A7
        • Research Site
    • New Brunswick
      • Bathurst、New Brunswick、加拿大、E2A 4Z9
        • Research Site
    • Newfoundland and Labrador
      • St. John's、Newfoundland and Labrador、加拿大、A1A 4Y3
        • Research Site
    • Ontario
      • Barrie、Ontario、加拿大、L4M 7G1
        • Research Site
      • Courtice、Ontario、加拿大、L1E 3C3
        • Research Site
      • Kingston、Ontario、加拿大、K7L 1S2
        • Research Site
      • Markham、Ontario、加拿大、L3P 1X2
        • Research Site
      • Oakville、Ontario、加拿大、L6J 7W5
        • Research Site
      • Sudbury、Ontario、加拿大、P3C 1X8
        • Research Site
      • Toronto、Ontario、加拿大、M5S 3B4
        • Research Site
      • Toronto、Ontario、加拿大、M8X 1Y9
        • Research Site
      • Waterloo、Ontario、加拿大、N2J 1C4
        • Research Site
  • 美国
    • Alabama
      • Mobile、Alabama、美国、36608
        • Research Site
    • California
      • Bakersfield、California、美国、93309
        • Research Site
      • Beverly Hills、California、美国、90212
        • Research Site
      • Fremont、California、美国、94538
        • Research Site
      • Los Angeles、California、美国、90036
        • Research Site
    • Colorado
      • Denver、Colorado、美国、80210
        • Research Site
      • Denver、Colorado、美国、80220
        • Research Site
    • Florida
      • Aventura、Florida、美国、33180
        • Research Site
      • Miami、Florida、美国、33144
        • Research Site
      • Pembroke Pines、Florida、美国、33028
        • Research Site
    • Indiana
      • Carmel、Indiana、美国、46032
        • Research Site
      • Indianapolis、Indiana、美国、46256
        • Research Site
      • New Albany、Indiana、美国、47150
        • Research Site
    • Kansas
      • Overland Park、Kansas、美国、66215
        • Research Site
      • Overland Park、Kansas、美国、66202
        • Research Site
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • Research Site
      • Owensboro、Kentucky、美国、42303
        • Research Site
    • Maryland
      • Rockville、Maryland、美国、20850
        • Research Site
    • Massachusetts
      • Andover、Massachusetts、美国、01810
        • Research Site
      • Worcester、Massachusetts、美国、01605
        • Research Site
    • Michigan
      • Clarkston、Michigan、美国、48346
        • Research Site
    • Nebraska
      • Omaha、Nebraska、美国、68144
        • Research Site
    • New Jersey
      • Verona、New Jersey、美国、07044
        • Research Site
    • North Carolina
      • Raleigh、North Carolina、美国、27612
        • Research Site
    • Ohio
      • Cincinnati、Ohio、美国、45249
        • Research Site
    • Rhode Island
      • Johnston、Rhode Island、美国、02919
        • Research Site
    • Tennessee
      • Nashville、Tennessee、美国、37205
        • Research Site
    • Texas
      • Bellaire、Texas、美国、77401
        • Research Site
      • Dallas、Texas、美国、75231
        • Research Site
      • Dallas、Texas、美国、75230
        • Research Site
      • San Antonio、Texas、美国、78229
        • Research Site
      • San Antonio、Texas、美国、78249
        • Research Site
    • Virginia
      • Norfolk、Virginia、美国、23507
        • Research Site

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 至 125年 (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:

  • Subject is ≥ 18 years of age at time of screening.
  • Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator.
  • Subject has involved body surface area (BSA) ≥ 10%, static physician global assessment (sPGA) ≥ 3, and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline.
  • Subject is naïve to etanercept.
  • Subject is a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept, as applicable.
  • Subject is able to self-inject etanercept or have a designee who can do so.
  • Subject has not used methotrexate within 4-weeks from the first dose of etanercept.
  • Subject has a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody.
  • Subject has no known history of active tuberculosis.
  • Subject has a negative test for tuberculosis during screening
  • Subject, if female and not at least 2 years postmenopausal or history of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, has a negative serum pregnancy test ≤ 4 weeks from starting etanercept and a negative urine pregnancy test at baseline (day 1).

Exclusion Criteria:

  • Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
  • Subject has any uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, pulmonary or liver disease, diabetes, anemia).
  • Myocardial infarction or unstable angina pectoris within the last year.
  • Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis.
  • Multiple sclerosis or any other demyelinating disease.
  • Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, Merkel cell carcinoma, or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first dose of etanercept. If malignancy occurred more than 5 years ago, documentation of disease-free state since treatment is required.
  • Known history of alcoholic hepatitis or immunodeficiency syndromes including human Immunodeficiency virus (HIV) infection.
  • Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first dose of etanercept.
  • Subject has a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infectives within 8 weeks prior to first dose of etanercept.
  • Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject.
  • Subject has any condition that could, in the opinion of the investigator, compromise the subject's ability to give written consent and/or comply with the study procedures, such as a history of substance abuse or a psychiatric condition.

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：不适用
  • 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
实验性的：Etanercept
Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
药品：Etanercept
Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.
其他名称：
  • 恩布雷®

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
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study
大体时间：Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.
Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).
Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24
大体时间：Week 24
Week 24
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12
大体时间：Week 12
Week 12
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24
大体时间：Week 24
Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.
Week 24
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12
大体时间：Week 12
Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.
Week 12

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

Amgen

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。

有用的网址

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

2015年1月1日

初级完成 (实际的)

2015年11月1日

研究完成 (实际的)

2015年11月1日

研究注册日期

首次提交

2014年10月22日

首先提交符合 QC 标准的

2014年10月22日

首次发布 (估计)

2014年10月24日

研究记录更新

最后更新发布 (估计)

2016年12月29日

上次提交的符合 QC 标准的更新

2016年11月2日

最后验证

2016年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 20101177

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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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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