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
2 other identifiers
observational
108
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2011
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2012
CompletedFirst Posted
Study publicly available on registry
March 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 21, 2015
July 1, 2015
1.1 years
March 14, 2012
July 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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
Interventions
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.
Eligibility Criteria
Study population includes adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
East Windsor, New Jersey, United States
Unknown Facility
Stony Brook, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Murfreesboro, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Related 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;27(1):19-26. doi: 10.3109/09546634.2015.1044492. Epub 2015 Jul 3.
PMID: 26138406RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Biotech, Inc. Clinical Trial
Janssen Biotech, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2012
First Posted
March 15, 2012
Study Start
June 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
July 21, 2015
Record last verified: 2015-07