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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
Sponsor:
Information provided by (Responsible Party):
Corrona, LLC.

Brief 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.

Condition or disease
Psoriasis

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort
Psoriasis
Pts presenting to enrolling sites across the US are invited to enroll if eligible



Primary Outcome Measures :
  1. 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 :
  1. Disease burden: Psoriatic area and severity index (PASI) [ Time Frame: every 6 months for 8 years ]
  2. Disease burden: Investigators Global Assessment (IGA) [ Time Frame: every 6 months for 8 years ]
  3. Disease burden: Body surface area (BSA) [ Time Frame: every 6 months for 8 years ]
  4. Percentage of patients with history of comorbidities [ Time Frame: time frame: at registry enrollment ]
  5. Physician reported: Fitzpatrick skin type [ Time Frame: time frame: every 6 months for 8 years ]
  6. Patient reported: EuroQOL-5D-3L [ Time Frame: time frame: every 6 months for 8 years ]
  7. Patient reported: Dermatology Quality of Life index (DLQI) [ Time Frame: time frame: every 6 months for 8 years ]
  8. Patient reported: Work productivity and Activity Impairment (WPAI) [ Time Frame: time frame: every 6 months for 8 years ]
  9. Patient reported: Pain, Fatigue, Itch score on Visual Analog Scale (VAS) (1-100) [ Time Frame: time frame: every 6 months for 8 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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.
Criteria

ELIGIBILITY CRITERIA∗ 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.

Inclusion Criteria:

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 Personal Identifiable Information (PII) that includes the following types of personal information at a minimum: 1) Full Name and 2) Date of Birth
  • Have started on or switched to a systemic psoriasis treatment within the previous 12 months.†Eligible medications for enrollment include the FDA-approved biologic treatments for psoriasis. Effective 20-Jun-2016, the non-biologic cohort is on hold. The following treatments will now be considered ineligible for enrollment into the Corrona Psoriasis Registry (until further notice): methotrexate, cyclosporine, or apremilast (Otezla) are allowed.

Exclusion Criteria:

  • Patient is participating in or planning to participate in an interventional clinical trial with a non-marketed or marketed investigational drug (i.e. phase I-IV drug trial).∆ Of note, concurrent participation in another observational registry study is not excluded

    † 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:

  1. The interruption in treatment lasted <180 days; AND
  2. No other systemic psoriasis medications were initiated during the time period when the eligible medication was not in use.

If either condition is 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 are reinitiating the drug.

∆Once clinical trial participation has ended, a patient is permitted to enroll in the reg istry if they satisfy the eligibility requirements. If a patient is exited from the registry for the exclusion, the patient is not permitted to re-enroll once their clinical trial participation ends.

∗These criteria are subject to change with the needs of the registry at the sole discretion of the Sponsor (Corrona).


Information from the National Library of Medicine

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


Sponsors and Collaborators
Corrona, LLC.
Investigators
Study Director: Jeffrey Greenberg, MD, MPH Corrona, LLC.

Additional Information:
Responsible Party: Corrona, LLC.
ClinicalTrials.gov Identifier: NCT02707341     History of Changes
Other Study ID Numbers: Corrona-PSO-500
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019

Keywords provided by Corrona, LLC.:
psoriasis
disease registry

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases