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| ID | Type | Description | Link |
|---|---|---|---|
| NOCOMPOUNDPSO0001 | Other Identifier | Janssen Research & Development, LLC |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants who participated in NCT01483599 (X-PLORE) study. |
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| Cohort 2 | Participants who participated in NCT00267969 (PHOENIX 1) study. |
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| Cohort 3 | Participants who participated in NCT00307437 (PHOENIX-2) study. |
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| Cohort 4 | Participants who participated in NCT00454584 (ACCEPT) study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who were treated in the CNTO1959PSO2001 study, C0743T08 study, C0743T09 or C0743T12 study will be assessed.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trials | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakersfield | California | United States | ||||
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Two buccal swab samples will be collected to extract Deoxyribonucleic acid (DNA).
| Los Angeles |
| California |
| United States |
| Ocala | Florida | United States |
| Alpharetta | Georgia | United States |
| Arlington Heights | Illinois | United States |
| Indianapolis | Indiana | United States |
| Louisville | Kentucky | United States |
| Andover | Massachusetts | United States |
| St Louis | Missouri | United States |
| New York | New York | United States |
| Portland | Oregon | United States |
| Webster | Texas | United States |
| Moncton | New Brunswick | Canada |
| Hamilton | Ontario | Canada |
| London | Ontario | Canada |
| Toronto | Ontario | Canada |
| Waterloo | Ontario | Canada |
| Montreal | Quebec | Canada |
| Québec | Quebec | Canada |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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