PPD™ CorEvitas™ Psoriasis (PSO) Early Treatment Response Non-Interventional Study
Recruiting · NCT07648602 · Observational (researchers observe without assigning treatment) · Lead sponsor: CorEvitas
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- To be eligible to participate in this study, an individual must meet all the following criteria:
- 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, 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.
Exclusion criteria
- 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 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.
Where it is running
1 location listed across 1 US state.
- CorEvitas, LLC - Waltham, Massachusetts, United States