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Nurse Education in Subjects With Psoriasis Undergoing Treatment With Adalimumab

2018年7月30日 更新者:Wake Forest University Health Sciences

The Effectiveness of Nurse Education and Its Impact on Treatment Adherence in Subjects With Moderate to Severe Psoriasis Undergoing Treatment With Adalimumab

This is a phase IV randomized, prospective open label study to asses the efficacy of an extended nurse eduction program in improving adherence to the prescribed treatment regimen in the treatment of moderate to severe psoriasis vulgaris.

研究概览

详细说明

This is a phase IV randomized, prospective open label study to asses the efficacy of an extended nurse eduction program in improving adherence to the prescribed treatment regimen in the treatment of moderate to severe psoriasis vulgaris. Twenty subjects, male or female, ages 18 and older in good health with moderate to severe chronic plaque type psoriasis for whom adalimumab is indicated according to the adalimumab prescribing information. All subjects must have a negative TB skin test according to prescribing guidelines. Subjects must be starting adalimumab for the first time, prescribed by their physician.

This is an open label trial. All subjects will be receiving adalimumab as prescribed by their physician. Half the group will be randomized to receive the additional nurse education program, the other half will receive the normal education materials provided by their physician.

研究类型

介入性

注册 (实际的)

7

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
      • Winston-Salem、North Carolina、美国、27157
        • Wake Forest University Health Sciences

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subjects must be male or female, 18 years of age or greater, in good health with moderate to severe plaque psoriasis for whom adalimumab is indicated according to the adalimumab prescribing information.
  • All subjects must have a negative TB skin test according to prescribing guidelines.
  • Subjects must be starting adalimumab for the first time, prescribed by their dermatologist.
  • Must give written informed consent.
  • Subject must be adult males or non-pregnant , non-lactating females.
  • Female subjects of childbearing potential must state that they are using measures to avoid conception through active means including, abstinence, oral contraceptives, intrauterine device, Depo-Provera, Norplant, tubal ligation, or vasectomy of the partner in a monogamous relationship.
  • Subjects may not be on concomitant systemic medications for their psoriasis such as methotrexate, acitretin, etretinate, cyclosporine, prednisone ot other biological agents or receiving phototherapy at the baseline visit, but no specific washout of these treatments will be required.
  • There is no washout for topical medications. Stable dosing of topical medications may be used throughout the duration of the study.

Exclusion Criteria:

  • Subjects who have any skin condition or disease that may require concurrent therapy or may confound the evaluation.
  • Subjects who have a history of hypersensitivity to adalimumab or history of hypersensitivity to any of the formulation components will be excluded from the study.
  • Female subjects who are not postmenopausal for at least one year, surgically sterile or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
  • Current enrollment in any research study involving an investigational drug.
  • Serious local infection or systemic infection within the three months prior to the first dose of investigational drug.
  • Treatment with another investigational drug within one month prior to study drug administration.
  • Concurrent treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab or mofetil or other systemic immunosuppressant agents.
  • Any active or history of HIV, Hepatitis or tuberculosis

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:卫生服务研究
  • 分配: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
有源比较器:Normal Nurse Education
Subjects receive normal nurse education materials provided by their physician.
Standard-of-care education from a dermatology nurse on the proper use of adalimumab
实验性的:Additional Nurse Education-
Subjects will receive additional nurse education beyond the normal education materials provided by their physician
Standard-of-care education from a dermatology nurse on the proper use of adalimumab
Additional education from a nurse on the use of adalimumab. This will include discussion of the pre-study evaluation with the subject, design of an Individual Educational Plan based on the pre-study evaluation, and a 30-60 minute educational session with the nurse educator at each study visit. Additional information concerning the benefits of the local support group and National Psoriasis Foundation will be provided. Additional education on self-injection and the opportunity to practice self-injection under the supervision of a nurse will also be provided. Subjects will also receive reminder phone calls to take each scheduled dose.

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
Change in Psoriasis Area Severity Index (PASI-75)
大体时间:Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
The Psoriasis Area Severity Index measures severity of psoriasis on a 0-6 scale for head, trunk, upper extremities, and lower extremities and amount of erythema, infiltration, and desquamation for each area. An overall score of 0-72 for the whole body is calculated from the observed severity values. Outcomes will be reported in terms of PASI 75, or number of participants showing at least 75% reduction in PASI score from baseline. Only final PASI 75 will be reported.
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months
Investigator's Global Assessment (IGA) of Psoriasis
大体时间:12 months
Investigator's Global Assessment (IGA) is rated on a scale of 0 (clear) to 5 (very severe). The outcome measure to be reported is the number of patients who reached a final IGA of 0 (clear) or 1 (almost clear).
12 months

次要结果测量

结果测量
措施说明
大体时间
Adherence to Adalimumab Treatment
大体时间:Baseline to 12 months
Adherence measured by average days between doses used, as measured by a Medication Event Monitoring System (MEMS) cap on the disposal container for used syringes.
Baseline to 12 months

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

  • 首席研究员:Steven R Feldman, MD, PhD、Wake Forest University Health Sciences

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

2010年1月1日

初级完成 (实际的)

2012年4月1日

研究完成 (实际的)

2012年4月1日

研究注册日期

首次提交

2011年9月13日

首先提交符合 QC 标准的

2011年9月14日

首次发布 (估计)

2011年9月16日

研究记录更新

最后更新发布 (实际的)

2018年8月29日

上次提交的符合 QC 标准的更新

2018年7月30日

最后验证

2018年7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

  • IRB00009876

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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