An Exploratory Genetic Study in Participants With Psoriasis

Psoriasis Clinical Trial

Official title:

Exploratory Genetic Study in Subjects With Moderate to Severe Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155192
• Other study ID #: CR103877
• Secondary ID: NOCOMPOUNDPSO000
• Status: Completed
• Phase: Phase 0
• First received: June 2, 2014
• Last updated: October 31, 2014
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

Description:

This is a Phase 0, exploratory (intended to be conducted early in Phase 1, involve limited human exposure, have no therapeutic intent and are not intended to examine clinical tolerability), multicenter (when more than one hospital or medical school team work on a medical research study) and pharmacogenomics study in participants with psoriasis. Participants who were treated in study Phase 2 NCT01483599 (X-PLORE), Phase 3 NCT00267969 (PHOENIX 1), Phase 3 NCT00307437 (PHOENIX 2) or Phase 3 NCT00454584 (ACCEPT), will be returning to their study site where a deoxyribonucleic acid (DNA) sample will be obtained for pharmacogenomics assessment. There will be no follow-up beyond the study site visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• No Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No