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

Обзор

This is a 16-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 2 (+/- 5 days), 4 (+/- 5 days), and 16 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 2, Week 4, and Week 16) using a structured and standardized data collection tool.

Подробное описание

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 2,4, and 16 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.

Вмешательства

• Другое Observational (Non-Interventional) Registry
  This is an observational (non-interventional) registry

Первичные конечные точки

• Creation of a cohort of psoriasis subjects [Срок оценки: Baseline (Day 0), Week 2, 4 and 16 weeks after initiation of advanced therapy]

Критерии участия

Критерии включения

The inclusion criteria for this study will be as follows:

• Patient is at least 18 years of age at the time of study enrollment
• Patient has a diagnosis of moderate to severe plaque psoriasis based on an Investigator Global Assessment (IGA, part of routine care) score of 3 or 4 at the time of Enrollment.
• Patient is initiating new Eligible Medication for the first time for the treatment of PSO.
• Patient is willing and able to provide informed consent to participate in this study.
• Patient is willing to be seen in-person by their treating dermatology provider at two (2), four (4), and sixteen (16) weeks following initiation of the advanced therapy.

Критерии исключения

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

• Patient is participating in a blinded clinical trial.
• Patients that do not receive at least 1 dose of the advanced therapy within 14 days following the Enrollment/Baseline visit for the study.
• Patients cannot be concurrently enrolled in both the CorEvitas PSO Registry and the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study.

A. Patients currently enrolled in the CorEvitas PSO Registry are ineligible for participation in the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study.

B. Patients otherwise meeting eligibility criteria can be enrolled in the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study C. Following completion or at time of Exit from the CorEvitas Psoriasis (PSO) Rapid 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• CorEvitas, LLC — Waltham

Идентификаторы

NCT: NCT07615712 · CorEvitas-PSO-505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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