The Corrona Psoriasis (PSO) Registry

Psoriasis Clinical Trial

Official title: Corrona Psoriasis (PSO) Registry

Status Enrolling by invitation

Clinical Trial Summary

The primary objective of the Corrona Psoriasis Registry is to study the comparative safety of approved psoriasis therapies in a North American cohort of psoriasis subjects treated by dermatologists. This includes assessing the incidence and nature of adverse events of special interest, including malignancy, in a real world population of psoriasis patients on new biologic therapies (e.g. secukinumab). Secondary objectives include analyzing the epidemiology and natural history of the disease, comorbidities, current treatment practices, and comparative effectiveness.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Psoriasis

• NCT number: NCT02707341
• Study type: Observational [Patient Registry]
• Source: CorEvitas
• Status: Enrolling by invitation
• Start date: April 2015
• Completion date: December 2100