An Exploratory Genetic Study in Participants With Psoriasis

Completed

• Conditions: Psoriasis
• Interventions: Drug: No Intervention

• Registration Number: NCT02155192
• Lead Sponsor: Janssen Research & Development, LLC

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).

Detailed 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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-04
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-31
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 712

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2	No Intervention	Participants who participated in NCT00267969 (PHOENIX 1) study.
Cohort 4	No Intervention	Participants who participated in NCT00454584 (ACCEPT) study.
Cohort 3	No Intervention	Participants who participated in NCT00307437 (PHOENIX-2) study.
Cohort 1	No Intervention	Participants who participated in NCT01483599 (X-PLORE) study.

Primary Outcome Measures

Name	Time	Method
Percentage of Responders With Association Between Clinical Response and Genetic Factor	Day 1	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.