Clinical trial NCT02707341: The CorEvitas Psoriasis (PSO) Registry
Official title: CorEvitas Psoriasis (PSO) Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Psoriasis
Keywords: psoriasis
disease registry
Lead sponsor: CorEvitas
Sponsor class: NETWORK
First posted: 2016-03-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are enrolled in the Psoriasis Registry during regularly-scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry. Physicians are selected carefully in an effort to ensure enrollment of subjects that represent a reasonable representation of a cross-section of the population throughout North America with Psoriasis. All potential sites are screened for clinical research experience and adherence to Good Clinical Practice (GCP) guidelines.

Brief summary: The primary objective of the CorEvitas 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.

Detailed 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.

Eligibility criteria: ELIGIBILITY CRITERIA∗ To be eligible for enrollment into the CorEvitas Psoriasis Registry, a patient must satisfy all of the inclusion criteria and none of the exclusion criteria listed below.

Inclusion Criteria:

The patient must:

1. Have been diagnosed with psoriasis by a dermatologist.
2. Be at least 18 years of age or older.
3. Be willing and able to provide written consent for participation in the registry.
4. Be willing and able to provide Personally Identifiable Information (PII) that includes the following types of personal information at a minimum: 1) Full Name and 2) Date of Birth.
5. Meet one of the following criteria.

Have started on or switched to a systemic psoriasis treatment within the previous 12 months†▲:

Exclusion Criteria:

1. Patient is participating in or planning to participate in a double-blind randomized of a psoriasis drug. Of note, concurrent participation in another observational registry or open-label Phase 3b/4 trial is not excluded.

Primary outcomes:
measure: Number of patients with adverse events (AEs) or serious adverse events (SAEs).
timeFrame: A minimum of 8 years from last patient enrolled
Secondary outcomes:
measure: Disease burden: Psoriatic area and severity index (PASI)
timeFrame: every 6 months for 8 years
measure: Disease burden: Investigators Global Assessment (IGA)
timeFrame: every 6 months for 8 years
measure: Disease burden: Body surface area (BSA)
timeFrame: every 6 months for 8 years
measure: Percentage of patients with history of comorbidities
timeFrame: time frame: at registry enrollment
measure: Physician reported: Fitzpatrick skin type
timeFrame: time frame: every 6 months for 8 years
measure: Patient reported: EuroQOL-5D-3L
timeFrame: time frame: every 6 months for 8 years
measure: Patient reported: Dermatology Quality of Life index (DLQI)
timeFrame: time frame: every 6 months for 8 years
measure: Patient reported: Work productivity and Activity Impairment (WPAI)
timeFrame: time frame: every 6 months for 8 years
measure: Patient reported: Pain, Fatigue, Itch score on Visual Analog Scale (VAS) (1-100)
timeFrame: time frame: every 6 months for 8 years
Other outcomes:
Locations:
Study officials:
affiliation: CorEvitas
name: Jeffrey Greenberg, MD, MPH
role: STUDY_DIRECTOR
References: