An Observational Study to Evaluate Patient-Reported Experiences of Living With Moderate-to-Severe Plaque Psoriasis
An Observational Study to Evaluate Patient-Reported Experiences of Living With Moderate-to-Severe Plaque Psoriasis
The purpose of the study is to develop a database containing patient-reported information
 that may be used to understand and to increase awareness of the impact that
 moderate-to-severe plaque psoriasis can have on both daily life and life in general from a
 patient's perspective. The database will include self-reported patient narratives on the
 topic of the experience of having moderate-to-severe plaque psoriasis and will include
 information on treatments received, as well as de-identified clinical photographs taken over
 the course of the disease.
This study is planned with the primary objective of developing a database containing
 patient-reported information that may be used to understand and increase awareness of the
 impact that moderate-to-severe plaque psoriasis can have on both daily life and life in
 general from a patient's perspective. This is a multicenter observational (no drug given to
 the patient) patient narrative study. The duration of study is 16 weeks and includes adult
 patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or
 systemic therapy. The study investigators are dermatologists who treat patients with
 moderate-to-severe plaque psoriasis. The study includes a screening visit 2 weeks before Week
 0 (baseline). Patients will be evaluated at screening for current or peak historical
 physician's global assessment (PGA) response (range 0-5). Patients will provide narratives at
 the Week 0 (baseline) visit and may add additional information at an interval visit or at the
 end of the study on Week 16. Photography will be performed at Week 0 and at the end of study
 at Week 16. Additional photographs will be taken if there is any change in disease status
 (e.g., disease improvement or worsening, change in treatment) occurring prior to the end of
 the study. Between Week 0 and Week 16, patients may return to the study site for 1 interval
 visit at the first clinically significant change in disease status, if applicable. The Week
 16 final assessment may be conducted as a telephone follow-up for patients who have had an
 interval visit between Week 0 and Week 16. If the patient did not return to the study site
 for an interval visit, the patient will return to the study site for a visit at Week 16. All
 assessments specified for the interval visit will be performed at Week 16. All patients will
 have the following data collected: PGA score, area of body involved, body surface area
 percent (BSA%, calculates percent of body surface area affected with psoriasis), Psoriasis
 Area and Severity Index (PASI) de-identified photographs, adverse events, and patient
 narratives. The information will be collected de-identified. Study materials (e.g.,
 demographic and disease characteristic forms, narratives, and photographs) will be coded
 using a unique patient identification (ID) number. Only de-identified information will be
 available to the Sponsor and related study personnel.
Inclusion Criteria:

 Adult male and female patients having diagnosis of plaque psoriasis for at least 6 months
 prior to screening

 -  Patients who are candidates for or are currently receiving the following: a.
 conventional systemic agents (eg, MTX, acitretin, cyclosporine, fumarates, or systemic
 psoralens plus ultraviolet A light [PUVA]), b. topical therapy and/or phototherapy
 (and are eligible for, but are not currently receiving oral systemic or biologic
 therapy), c. biologic therapy for moderate to severe plaque psoriasis

 -  Have a peak historical or current physician's global assessment (PGA) of greater than
 or equal to 3 (range 0-5)

 -  Patients must have the ability to read and speak English

 -  Patients must reside in the US.

 Exclusion Criteria:

 Patients with guttate, erythrodermic, or pustular psoriasis (all are various types of
 psoriasis)

 - Patients with serious concomitant illness that could require the use of systemic
 corticosteroids or otherwise interfere with the patient's participation in the trial