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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
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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 16 and 24 weeks after initiation of advanced therapy. The changes will be determined by completion of questionnaires | Baseline (Day 0), Week 16 and 24 weeks after initiation of advanced therapy |
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Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in the 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.
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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 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.
| 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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| CorEvitas, LLC | Not yet recruiting | Waltham | Massachusetts | 02451 | United States |
|
| 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 |