An Exploratory Genetic Study in Participants With Psoriasis
Exploratory Genetic Study in Subjects With Moderate to Severe Psoriasis
2 other identifiers
observational
712
2 countries
19
Brief Summary
The purpose of this study is to evaluate the association between genetic factors and response to treatment (guselkumab, ustekinumab, adalimumab, or etanercept) and psoriasis (scaly skin rash).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Shorter than P25 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 2, 2014
CompletedFirst Posted
Study publicly available on registry
June 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedNovember 3, 2014
October 1, 2014
6 months
June 2, 2014
October 31, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Responders With Association Between Clinical Response and Genetic Factor
Participants with clinical response from previous studies will be evaluated for the association with genetic factors (for example, human leukocyte antigen \[HLA\], Cw6 allele). Clinical response in previous studies were evaluated by psoriasis area and severity index (PASI) score: a widely used tool for the measurement of severity of psoriasis. This is a test of how bad a participant's psoriasis is. The scale combines redness, scaling, and thickness, as well as overall body involvement to determine the PASI score, scale ranges from 0 (best) to 72 (worst); and physician global assessment (PGA): The PGA is 6-point scale used in clinical trials of various diseases. In this the physician checks the state of the disease and gives them score from 0 (clear) to 5 (severe). Percentage of participants will be reported.
Day 1
Study Arms (4)
Cohort 1
Participants who participated in NCT01483599 (X-PLORE) study.
Cohort 2
Participants who participated in NCT00267969 (PHOENIX 1) study.
Cohort 3
Participants who participated in NCT00307437 (PHOENIX-2) study.
Cohort 4
Participants who participated in NCT00454584 (ACCEPT) study.
Interventions
Eligibility Criteria
Participants who were treated in the CNTO1959PSO2001 study, C0743T08 study, C0743T09 or C0743T12 study will be assessed.
You may qualify if:
- Participants must have been randomly assigned and treated in the NCT01483599 (X-PLORE), NCT00267969 (PHOENIX 1), NCT00307437 (PHOENIX-2) , or NCT00454584 (ACCEPT) studies
- Sign an informed consent document indicating that they understand the purpose of and procedures required for this study and are willing to participate in this study
You may not qualify if:
- Participants has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Bakersfield, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Alpharetta, Georgia, United States
Unknown Facility
Arlington Heights, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Andover, Massachusetts, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Webster, Texas, United States
Unknown Facility
Moncton, New Brunswick, Canada
Unknown Facility
Hamilton, Ontario, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Waterloo, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Québec, Quebec, Canada
Biospecimen
Two buccal swab samples will be collected to extract Deoxyribonucleic acid (DNA).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trials
Janssen Research & Development, LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2014
First Posted
June 4, 2014
Study Start
March 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
November 3, 2014
Record last verified: 2014-10