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PPD™ CorEvitas™ Psoriasis (PSO) Early Treatment Response Non-Interventional Study

2026年8月25日 更新者:CorEvitas
This is a 24-week prospective, single-arm cohort, study of patients initiating advanced therapy for the treatment of moderate-to-severe plaque PSO. Eligible patients must be willing to be seen in-person by their treating physician for a Baseline visit (with first dose of the advanced therapy occurring within 14 days), and at 16 (+/- 5 days) and 24 weeks (+14 days) calculated based on date of first dose of the advanced therapy and must provide informed consent prior to enrolling in the study or completing study-specific questionnaires or procedures. Data will be collected from both subjects and their treating dermatology provider at predetermined scheduled intervals (Baseline, Week 16 and Week 24) using a structured and standardized data collection tool.

研究概览

详细说明

Data collected through the study may be used to address a range of research questions and use cases and objectives, including but not limited to study

  • Creation of a cohort of psoriasis subjects to describe the clinical and patient-reported outcomes (PRO) and changes at 16 and 24 weeks after initiation of the advanced therapy.
  • Inform clinical decision making by subjects and treating providers. This will be enabled through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), and the recording of medication utilization data.
  • Describe subject characteristics (i.e. comorbidity, medication history, sociodemographic) at baseline.
  • For subjects with a dermatologist-confirmed diagnosis of psoriatic arthritis at baseline, to describe the joint pain and patient wellness.

研究类型

观察性的

注册 (估计的)

2500

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。

学习联系方式

学习地点

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

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

概率样本

研究人群

Study population must be at least 18 years of age and is initiating advanced therapy for the treatment of moderate-to-severe plaque PSO. Eligible patients must be willing to be seen in-person by their treating physician for a Baseline visit (with first dose of the advanced therapy occurring within 14 days), and at 16 (+/- 5 days) and 24 weeks (+14 days) calculated based on date of first dose of the advanced therapy and must provide informed consent prior to enrolling in the study or completing study-specific questionnaires or procedures.

描述

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all the following criteria:

  1. Patient is at least 18 years of age at the time of study enrollment.
  2. Patient has a diagnosis of moderate to severe plaque psoriasis based on an investigator Global Assessment (IGA, score of 3 or 4 at the time of Enrollment).
  3. Patient is initiating new Eligible Medication for the first time for the treatment of PSO.
  4. Patient is willing and able to provide informed consent to participate in this study.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in the study:

  1. Patient is participating in a blinded clinical trial.
  2. Patients that do not receive at least 1 dose of the advanced therapy within 14 days following the Enrollment/Baseline visit for the study.
  3. Patients cannot be concurrently enrolled in both the CorEvitas PSO Registry and the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study. A. Patients currently enrolled in the CorEvitas PSO Registry are ineligible for participation in the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study.

B. Patients otherwise meeting eligibility criteria can be enrolled in the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study C. Following completion or at time of Exit from the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study, patients will be eligible to enroll into the CorEvitas PSO Registry for long term follow-up at the standard of care cadence supported by the registry. A separate Informed consent will be obtained.

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

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
Creation of a cohort of psoriasis subjects
大体时间:Baseline (Day 0), Week 16 and 24 weeks after initiation of advanced therapy
Creation of a cohort of psoriasis subjects to describe the changes at 16 and 24 weeks after initiation of advanced therapy. The changes will be determined by completion of questionnaires
Baseline (Day 0), Week 16 and 24 weeks after initiation of advanced therapy

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

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 (实际的)

2026年6月1日

初级完成 (估计的)

2036年12月31日

研究完成 (估计的)

2036年12月31日

研究注册日期

首次提交

2026年6月5日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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