PPD™ CorEvitas™ Psoriasis (PSO) Rapid Response Non-Interventional Study
ConditionPsoriasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCorEvitas
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational (Non-Interventional) Registry
Other interventionThis is an observational (non-interventional) registry
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Creation of a cohort of psoriasis subjects
Creation of a cohort of psoriasis subjects to describe the changes at 2,4, and 16 weeks after initiation of the advanced therapy.
Time frame
Baseline (Day 0), Week 2, 4 and 16 weeks after initiation of advanced therapy Source ClinicalTrials.gov