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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01555606
First received: March 14, 2012
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Moderate to Severe Plaque Psoriasis
Other: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter, Observational, Noninterventional, Narrative Study to Evaluate Patient-Reported Experiences of Living With Moderate-to-Severe Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:
  • To develop a database for patients with moderate-to-severe plaque psoriasis containing patient-reported information [ Time Frame: Week 0 to Week 16 ] [ Designated as safety issue: No ]
    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.


Enrollment: 108
Study Start Date: June 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555606

Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
Sacramento, California, United States
United States, Michigan
Ann Arbor, Michigan, United States
United States, New Jersey
East Windsor, New Jersey, United States
United States, New York
Stony Brook, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Tennessee
Murfreesboro, Tennessee, United States
United States, Texas
Dallas, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Janssen Biotech, Inc.
Investigators
Study Director: Janssen Biotech, Inc. Clinical Trial Janssen Biotech, Inc.
  More Information

No publications provided

Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01555606     History of Changes
Other Study ID Numbers: CR100687, NOCOMPOUNDPSO4001
Study First Received: March 14, 2012
Last Updated: February 18, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Janssen Biotech, Inc.:
Psoriasis
Patient-reported outcome
Quality of Life

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

ClinicalTrials.gov processed this record on September 22, 2014