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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational (Non-Interventional) Registry | Other | This is an observational (non-interventional) registry |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0), Week 2, 4 and 16 weeks after initiation of advanced therapy |
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Inclusion Criteria:
The inclusion criteria for this study will be as follows:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in the 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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cathy Cheney | Contact | +1 508 408 5433 | corevitasregistrytrials@corevitas.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CorEvitas, LLC | Recruiting | Waltham | Massachusetts | 02451 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D012042 | Registries |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011996 | Records |
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| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |