An Observational Study to Evaluate Patient-Reported Experiences of Living With Moderate-to-Severe Plaque Psoriasis

A Multicenter, Observational, Noninterventional, Narrative 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.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Other: No intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
  • California
    • Sacramento, California, United States
  • Michigan
    • Ann Arbor, Michigan, United States
  • New Jersey
    • East Windsor, New Jersey, United States
  • New York
    • Stony Brook, New York, United States
  • North Carolina
    • Winston-Salem, North Carolina, United States
  • Tennessee
    • Murfreesboro, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
  • Virginia
    • Norfolk, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population includes adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moderate to severe plaque psoriasis patients; The group includes adult patients (either male or female) diagnosed with plaque psoriasis for at least 6 months prior to screening with PGA value of greater than or equal to 3. The patients in the group needed are currently receiving treatment with conventional systemic agents, topical therapy and/or phototherapy or biologic therapy	Other: No intervention; Patients will not be administered any treatment as part of the study and will receive usual care. Patients will be evaluated for PROs by obtaining narratives and photographs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To develop a database for patients with moderate-to-severe plaque psoriasis containing patient-reported information	The database will contain 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. The database will include self-reported patient narratives on the topic of the experience of having moderate-to-severe plaque psoriasis, information on treatments received, and de-identified clinical photographs taken over the course of the disease.	Week 0 to Week 16

Collaborators and Investigators

• Sponsor: Janssen Biotech, Inc.

Publications and helpful links

General Publications

• Pariser D, Schenkel B, Carter C, Farahi K, Brown TM, Ellis CN; Psoriasis Patient Interview Study Group. A multicenter, non-interventional study to evaluate patient-reported experiences of living with psoriasis. J Dermatolog Treat. 2016;27(1):19-26. doi: 10.3109/09546634.2015.1044492. Epub 2015 Jul 3.

Helpful Links

• The Early Online publication of the Psoriasis Patient Narratives

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 14, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Psoriasis; Quality of Life; Patient-reported outcome
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CR100687; NOCOMPOUNDPSO4001 (Other Identifier: Janssen Biotech)