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Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.

2016年10月27日 更新者:Aida Lugo-Somolinos, MD、University of North Carolina, Chapel Hill

Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis

Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown.

In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).

研究概览

研究类型

介入性

注册 (实际的)

18

阶段

  • 不适用

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

    • North Carolina
      • Chapel Hill、North Carolina、美国、27516
        • UNC Dermatology Clinical Trials Unit

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 55年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Must understand and voluntarily sign an informed consent form.
  • Must be male or female and age 18-55 years at time of consent.
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Have chronic plaque psoriasis for more than 6 months with a PASI score of 12 or greater at Baseline.
  • Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1).
  • Negative PPD at Screening or 3 months earlier.
  • Have not used any biologic treatment for psoriasis in the past 12 months.

Exclusion Criteria:

  • Inability to provide voluntary consent
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  • Pregnant, trying to become pregnant or breastfeeding
  • Prior diagnosis of coronary artery disease (CAD) or heart disease.
  • Systemic fungal infection
  • History of past or active mycobacterial infection with any species (including Mycobacterium tuberculosis). Latent Mycobacterium tuberculosis infection as indicated by a positive (more than 15mm induration)Purified Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
  • History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
  • Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
  • Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
  • History of Human Immunodeficiency Virus (HIV) infection or Hepatitis C
  • Positive Hepatitis B Surface antigen at screening
  • Malignancy or history of malignancy (except for treated [ie, cured] basal-cell skin carcinomas > 3 years prior to screening)
  • History of any demyelinating disorder such as multiple sclerosis.

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:Adalimumab 40mg
Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months
40mg subcutaneously, every other week for 6 months
其他名称:
  • 修美乐

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 Change in Endothelial Function Compared to Baseline.
大体时间:6 months
Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).
6 months

次要结果测量

结果测量
措施说明
大体时间
Changes in IL-6 Profile Compared to Baseline
大体时间:6 months
IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.
6 months
Changes in Adiponectin Profile Compared to Baseline
大体时间:24 weeks
Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.
24 weeks

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。

合作者

调查人员

  • 首席研究员:Aida Lugo-Somolinos, MD、University of North Carolina, Chapel Hill

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

2011年3月1日

初级完成 (实际的)

2015年3月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2011年3月18日

首先提交符合 QC 标准的

2011年3月18日

首次发布 (估计)

2011年3月22日

研究记录更新

最后更新发布 (估计)

2016年12月26日

上次提交的符合 QC 标准的更新

2016年10月27日

最后验证

2016年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

no plan to share data

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.

Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]的临床试验

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