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

CorEvitas2,500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

2,500

Conditions

Psoriasis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Creation of a cohort of psoriasis subjects

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

Time frame: Baseline (Day 0), Week 16 and 24 weeks after initiation of advanced therapy