Exploratory Genetic Study in Subjects With Moderate to Severe Psoriasis
概览
- 阶段
- 不适用
- 干预措施
- No Intervention
- 疾病 / 适应症
- Psoriasis
- 发起方
- Janssen Research & Development, LLC
- 入组人数
- 712
- 主要终点
- Percentage of Responders With Association Between Clinical Response and Genetic Factor
- 状态
- 已完成
- 最后更新
- 11年前
概览
简要总结
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).
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 1
Participants who participated in NCT01483599 (X-PLORE) study.
干预措施: No Intervention
Cohort 2
Participants who participated in NCT00267969 (PHOENIX 1) study.
干预措施: No Intervention
Cohort 3
Participants who participated in NCT00307437 (PHOENIX-2) study.
干预措施: No Intervention
Cohort 4
Participants who participated in NCT00454584 (ACCEPT) study.
干预措施: No Intervention
结局指标
主要结局
Percentage of Responders With Association Between Clinical Response and Genetic Factor
时间窗: 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.