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.
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|
Primary Outcome Measures
- 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.
Secondary Outcome Measures
- 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 ]
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
To be eligible for enrollment into the Corrona Psoriasis Registry, a patient must satisfy all of the inclusion criteria and none of the exclusion criteria listed below.
The patient must:
- Have been diagnosed with psoriasis by a dermatologist.
- Be at least 18 years of age or older.
- Be willing and able to provide written consent for participation in the registry.
- 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.
- Meet one of the following criteria.
Have started on or switched to a systemic psoriasis treatment within the previous 12 months†▲:
- Eligible medications± for enrollment include the FDA-approved biologic and biosimilar treatments for psoriasis (adalimumab (Humira), adalimumab Biosimilar, brodalumab (Siliq), certolizumab pegol (Cimzia), etanercept (Enbrel), etanercept Biosimilar, guselkumab (Tremfya), infliximab (Remicade), infliximab Biosimilar, ixekizumab (Taltz), risankizumab (Skyrizi), secukinumab (Cosentyx), tildrakizumab (Ilumya), and ustekinumab (Stelara) are allowed.OR
- Eligible medications for enrollment include apremilast, methotrexate, cyclosporine and acitretin. If enrolling on one of these medications the patient must also be biologic-naïve.
- 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.
EARLY Follow-Up Visit Criteria:
A registry Follow-Up Visit should be conducted whenever a patient is prescribed or starts a new eligible medication (FDA-approved biologic and biosimilar treatments for psoriasis) that has not been used in the previous 12 months, regardless of when the last registry visit submission was made.Ω
- Past use of an Eligible Medication does not exclude a patient from an Early Follow-Up Visit.
- The next anticipated visit that registry CRFs should be completed is then calculated from the Early Follow-Up Visit date (≥ 150 days).
Follow-Up Visit Criteria:
Registry Follow-Up data collection should be done at the time of routine clinical encounters approximately every 6 months. Routine or standard of care clinical encounters may occur between two Corrona visits, but the data collected in the Follow-Up CRFs should cover the time period since the last Corrona visit. For planning purposes, each subsequent Follow-Up Visit is anchored to the date of the last eligible Corrona visit.
A Follow-Up Visit is eligible for payment as long as 150 days have passed since the last visit submission. A Follow-Up Visit is not eligible for payment if conducted less than 150 days since the last registry visits except when the “Early” Follow-Up Visit criteria is satisfied.
† If a potential subject is being prescribed an eligible systemic psoriasis treatment on the day of the Enrollment Visit, the subject is eligible for enrollment into the registry the same day. If a subject is prescribed an eligible medication at the enrollment visit, in order for the subject to remain in the registry, one of the following conditions must be met at the time of the first registry follow-up visit or within 6 months (180 days) of the enrollment visit, or which occurs first:
1) The eligible medication was started; OR 2) Another eligible medication was started that has not been used in the previous 12 months.
If a patient has experienced an interruption in treatment of an eligible medication in the 12 months after initiation, in order for the patient to be eligible for enrollment the following two conditions must be met:
The interruption in treatment lasted <180 days; AND
No other systemic psoriasis medications were initiated during the time period when the eligible medication was not in use.
If both conditions are not met, the patient is ineligible for enrollment based on the interrupted eligible medication. In order for the patient to be eligible for enrollment by this medication, they would need to be off the drug for at least 12 months prior to restarting therapy and enrolled within 12 months from the time they restart the drug.
An enrollment cap is placed on each TNF-inhibitor (Humira, Enbrel, Remicade, Cimzia) and Stelara at 150 patients per year.
NOTE: Corrona will monitor annual enrollment for each TNF-inhibitor and Stelara and provide updates as needed. The cap is for the overall registry. Biosimilars will not count toward the originator biologic
Once clinical trial participation has ended, a patient is permitted to enroll in the registry if they satisfy the eligibility requirements. If exited from the registry for the exclusion, the patient is not permitted to re-enroll once their clinical trial participation ends. Ω Only one (1) early Follow-Up Visit is allowed for each new eligible medication initiated during long-term follow-up. This means that the early registry visit can either be conducted on the day the patient is prescribed the new medication or on the day the drug is started (i.e. when the first does is received).
These criteria are subject to change with the needs of the registry at the sole discretion of the Sponsor (Corrona).