PsoriasisNCT02155192
An Exploratory Genetic Study in Participants With Psoriasis
An observational study of Psoriasis, run by Janssen Research & Development, LLC at 19 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 712 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Mar 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who were treated in the CNTO1959PSO2001 study, C0743T08 study, C0743T09 or C0743T12 study will be assessed.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States12 sites
Study site
Alpharetta, Georgia
Study site
Andover, Massachusetts
Study site
Arlington Heights, Illinois
Study site
Bakersfield, California
Study site
Indianapolis, Indiana
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
New York, New York
Study site
Ocala, Florida
Study site
Portland, Oregon
Study site
St Louis, Missouri
Study site
Webster, Texas
Canada7 sites
Study site
Hamilton, Ontario
Study site
London, Ontario
Study site
Moncton, New Brunswick
Study site
Montreal, Quebec
Study site
Québec, Quebec
Study site
Toronto, Ontario
Study site
Waterloo, Ontario
About this study
Official title: Exploratory Genetic Study in Subjects With Moderate to Severe Psoriasis
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).
Read the 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.
- Conditions
- Psoriasis
- Being tested
- No Intervention
- Keywords
- CNTO1959PSO2001, C0743T08, C0743T09, C0743T12, Psoriasis, Pharmacogenomics
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants who participated in NCT01483599 (X-PLORE) study. Receives: Drug: No Intervention | |
| Cohort 2 | Participants who participated in NCT00267969 (PHOENIX 1) study. Receives: Drug: No Intervention | |
| Cohort 3 | Participants who participated in NCT00307437 (PHOENIX-2) study. Receives: Drug: No Intervention | |
| Cohort 4 | Participants who participated in NCT00454584 (ACCEPT) study. Receives: Drug: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trials, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155192
- Sponsor's protocol ID
- CR103877
- Other IDs
- NOCOMPOUNDPSO0001
- Status last verified
- Oct 2014
- First submitted
- 2 Jun 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Genetic Study in Subjects With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT02155192
- Acronym / sponsor ID
- CR103877
- Conditions
- Psoriasis
- Keywords
- CNTO1959PSO2001, C0743T08, C0743T09, C0743T12, Psoriasis, Pharmacogenomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: No InterventionParticipants who participated in NCT01483599 (X-PLORE) study. |
| Cohort 2 | – | Drug: No InterventionParticipants who participated in NCT00267969 (PHOENIX 1) study. |
| Cohort 3 | – | Drug: No InterventionParticipants who participated in NCT00307437 (PHOENIX-2) study. |
| Cohort 4 | – | Drug: No InterventionParticipants who participated in NCT00454584 (ACCEPT) study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who were treated in the CNTO1959PSO2001 study, C0743T08 study, C0743T09 or C0743T12 study will be assessed.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Percentage of Responders With Association Between Clinical Response and Genetic Factor
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trials study director
Janssen Research & Development, LLC
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Janssen Research & Development, LLC at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Responders With Association Between Clinical Response and Genetic Factor (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2014; AzTrials last refreshed its copy on 31 Oct 2026.