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

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:

A Multicenter, Observational, Noninterventional, Narrative Study to Evaluate Patient-Reported Experiences of Living With Moderate-to-Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555606
• Other study ID #: CR100687
• Secondary ID: NOCOMPOUNDPSO400
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2012
• Last updated: July 20, 2015
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2015
• Source: Janssen Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Moderate to Severe Plaque Psoriasis
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Biotech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Jan;27(1):19-26. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   The Early Online publication of the Psoriasis Patient Narratives