The Corrona Psoriasis (PSO) Registry
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|ClinicalTrials.gov Identifier: NCT02707341|
Recruitment Status : Enrolling by invitation
First Posted : March 14, 2016
Last Update Posted : January 4, 2019
|Condition or disease|
Based on the operating procedures established by the Corrona Rheumatoid Arthritis (RA) Registry, the Psoriasis Registry will use a parallel structure based on a design and strategy developed by Corrona, LLC. This registry will be cooperatively managed by scientific, operational, and quality leaders at Corrona and medical leaders appointed by the National Psoriasis Foundation (NPF).
Investigators may enroll patients who have started on or switched to a systemic agent for psoriasis within the previous twelve months. Currently approved subcutaneous biologics are indicated for adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The currently approved intravenous biologic agent is indicated for adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy, and when other systemic therapies are medically less appropriate. All patients will receive standard of care treatments prescribed by the investigator, in accordance with the FDA-approved drug labeling, and all treatment decisions are the sole responsibility of the investigator.
This study will be conducted at approximately 200 sites across North America. Sites are assessed and selected through interviews with potential investigators and a corresponding site feasibility survey that includes information on the investigator's qualifications, previous research experience, and the availability of support staff, sub-investigators, and patient population.
The Corrona Psoriasis Registry is a longitudinal, observational study; therefore, the duration is indefinite with no pre-determined stop date. The enrollment period is estimated to take approximately four years, and subjects will be followed for a minimum of eight years beginning from the time the subject is enrolled.
The design is a prospective, multicenter, observational registry for subjects with psoriasis. Longitudinal follow-up data is obtained via Corrona Questionnaires completed by both subjects and their treating dermatologists (also known as "Providers" for a Corrona registry study) every 6 months (+/- 30 days). The registry is designed to collect data on patient demographics, smoking history, disease duration, disease severity, disease activity, history of prior psoriasis treatment, comorbidities, hospitalizations, adverse events of special interest, medication use, and laboratory results.
The registry is linked to external data sources including the Centers for Disease Control's National Death Index (NDI), the Centers for Medicare and Medicaid Services (CMS), and other administrative data sources to support drug safety monitoring and other research activities.
Any adverse events that are spontaneously volunteered by the subject or discovered as a result of general questioning by the investigator should be recorded on the Provider Follow-up Questionnaire for that visit.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||8 Years|
|Official Title:||Corrona Psoriasis (PSO) Registry|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2100|
|Estimated Study Completion Date :||December 2100|
Pts presenting to enrolling sites across the US are invited to enroll if eligible
- Number of patients with adverse events (AEs) or serious adverse events (SAEs). [ Time Frame: A minimum of 8 years from last patient enrolled ]
Targeted events include malignancy, cardiovascular disease, serious infection, inflammatory bowel disease, gastrointestinal perforation, neurological events, hepatic events, and general serious adverse events.
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Disease burden: Psoriatic area and severity index (PASI) [ Time Frame: every 6 months for 8 years ]
- Disease burden: Investigators Global Assessment (IGA) [ Time Frame: every 6 months for 8 years ]
- Disease burden: Body surface area (BSA) [ Time Frame: every 6 months for 8 years ]
- Percentage of patients with history of comorbidities [ Time Frame: time frame: at registry enrollment ]
- Physician reported: Fitzpatrick skin type [ Time Frame: time frame: every 6 months for 8 years ]
- Patient reported: EuroQOL-5D-3L [ Time Frame: time frame: every 6 months for 8 years ]
- Patient reported: Dermatology Quality of Life index (DLQI) [ Time Frame: time frame: every 6 months for 8 years ]
- Patient reported: Work productivity and Activity Impairment (WPAI) [ Time Frame: time frame: every 6 months for 8 years ]
- Patient reported: Pain, Fatigue, Itch score on Visual Analog Scale (VAS) (1-100) [ Time Frame: time frame: every 6 months for 8 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707341
|Study Director:||Jeffrey Greenberg, MD, MPH||Corrona, LLC.|