- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01677598
A Study to Evaluate Ustekinumab in Patients With Plaque Psoriasis in Asia-Pacific Countries (MARCOPOLO)
January 25, 2016 updated by: Johnson & Johnson Pte Ltd
A Study to Evaluate Ustekinumab in Clinical Practice in Patients With Plaque Psoriasis in Asia-Pacific Countries
The purpose of this study is to determine how patients use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries.
Study Overview
Detailed Description
This is an open-label (all people know the identity of the medication), multicenter, Phase 4, observational study (no study medication was administered during the study) designed to assess how patients will use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries.
The study will consist of 4 study visits which will take place over the duration of 1 year.
At the first visit (ie, Week 0), eligibility for the study will be determined (it will be screening and baseline visit).
At each subsequent visit (Weeks 16, 28, and 52), exposure to ustekinumab will be recorded, questionnaires for efficacy will be completed, and information about adverse events and concomitant medications will be collected.
As many patient reported outcome questionnaires as possible will be administered, depending on the availability of validated translations.
Safety will be assessed by monitoring of adverse events, vital signs and physical examination.
Study Type
Observational
Enrollment (Actual)
169
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jakarta Pusat, Indonesia
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Incheon, Korea, Republic of
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Seongnam, Korea, Republic of
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Seoul, Korea, Republic of
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Suwon, Korea, Republic of
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Johor Bahru, Malaysia
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Pulau Pinang, Malaysia
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Singapore, Singapore
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Taipei, Taiwan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients at least 18 years of age with a diagnosis of plaque psoriasis, according to the dermatologists' clinical judgment
Description
Inclusion Criteria:
- Have a diagnosis of plaque psoriasis, according to the dermatologists' clinical judgment
- Agree to initiate treatment with ustekinumab on the same day as enrollment into the study
- Have not received anti-IL12/23 therapies within 6 months prior to enrollment into the study
Exclusion Criteria:
- Has difficulty understanding questions posed by any of the questionnaires
- Are currently participating in an investigational drug clinical study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients with plaque psoriasis
Patients with plaque psoriasis using ustekinumab in Asia-Pacific countries.
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No intervention will be administered during study.
This will be an observational study in patients using ustekinumab as label-recommended or other/missed dose interval in Asia-Pacific countries
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval
Time Frame: up to 52 weeks
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Number of psoriasis patients who use ustekinumab with label-recommended interval or other/missed dose interval will be assessed at Weeks 0, 16, 28, 52.
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up to 52 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Epidemiologic characteristics of the psoriasis population
Time Frame: Week 0
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Epidemiologic characteristics of the psoriasis patients (sex, age, race, weight height, and peak disease level) will be determined.
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Week 0
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Change from baseline (Week 0) in Psoriasis Area and Severity Index (PASI) score at Weeks 16, 28 and 52
Time Frame: Baseline (Week 0), Weeks 16, 28 and 52
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The PASI is a physician-administered assessment tool used for assessing and grading the severity of psoriatic lesions and their response to therapy.
The PASI produces a numeric score that can range from 0 (no disease) to 72 (maximal disease).
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Baseline (Week 0), Weeks 16, 28 and 52
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Change from baseline (Week 0) in Nail Psoriasis Severity Index (NAPSI) score at Weeks 16, 28, and 52
Time Frame: Baseline, Weeks 16, 28 and 52
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NAPSI is used for assessing and grading the severity of nail psoriasis.
Each nail is divided with imaginary horizontal and longitudinal lines into quadrants.
Each nail is given a score for nail matrix psoriasis (0 to 4) and nail bed psoriasis (0 to 4) depending on the presence of any of the features of nail psoriasis in the 4 quadrants as: 0 (none), 1 (present in 1/4 nail), 2 (2/4), 3 (3/4), and 4 (4/4).
Each nail gets a matrix score and a nail bed score, the total of which is the score for that nail (0 to 8).
Each nail is evaluated, and the sum of all the nails is the total NAPSI score.
The sum of the scores from all nails is 0 to 160 (Both finger and toe nails are included).
Higher scores indicate worsening.
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Baseline, Weeks 16, 28 and 52
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Change from baseline in EuroQol 5 Dimensional Questionnaire (EQ-5D) index score and EQ visual analog scale (VAS) at Weeks 16, 28, and 52
Time Frame: Baseline, Weeks 16, 28 and 52
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The EQ-5D (EuroQol Group) is a validated generic measure of quality of life which usually requires less than 1 minute to complete (eg, the questionnaire may have questions about mobility, self care, usual activities, pain/discomfort and anxiety/depression.
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Baseline, Weeks 16, 28 and 52
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Change from baseline (Week 0) in Dermatology Life Quality Index (DLQI) score
Time Frame: Baseline, Weeks 16, 28 and 52
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The DLQI is a patient-completed 10-item questionnaire that, in addition to evaluating overall quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment.
The aim of this questionnaire is to measure how much your skin problem has affected your life over the last week.
For each of 10 questions patient has to select one of the following options: very much, a lot, a little, not at all.
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Baseline, Weeks 16, 28 and 52
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Change from baseline (Week 0) in Patient Benefit Index (PBI) score at Weeks 16, 28, and 52
Time Frame: Baseline, Weeks 16, 28 and 52
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The PBI is a patient-defined benefit assessment tool.
Patients select personally relevant treatment goals from a standardized list of benefits called the Patient Needs Questionnaire.
An evaluation of those treatment goals assessed by the patient is captured on the Patient Benefit Questionnaire.
The PBI is calculated from the sum of the benefit items weighted by their respective relevance divided by the number of relevant items.
Values between 0 (no benefit) and 4 (maximal patient-defined benefit) are possible.
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Baseline, Weeks 16, 28 and 52
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Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI)
Time Frame: up to 52 weeks
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Number of patients achieving PASI 50, 75, and 90 response (ie, at least 50%, 75% and 90% improvement in PASI) will be evaluated at Weeks 16, 28, and 52.
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up to 52 weeks
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Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points
Time Frame: up to 52 weeks
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Number of patients achieving a DLQI improvement (reduction) of greater than or equal to 5 points will be evaluated at Weeks 16, 28, and 52.
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up to 52 weeks
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Number of patients achieving a score of 0 or 1 in DLQI
Time Frame: up to 52 weeks
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Number of patients achieving a score of 0 or 1 in DLQI will be evaluated at Weeks 16, 28, and 52.
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up to 52 weeks
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Number of patients achieving an improvement in PBI
Time Frame: up to 52 weeks
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Number of patients achieving an improvement in PBI will be evaluated at Weeks 16, 28, and 52.
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up to 52 weeks
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Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease)
Time Frame: up to 52 weeks
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Number of patients with comorbidities (obesity, hypertension, diabetes, dyslipidemia, and heart disease) will be evaluated at baseline, Weeks 16, 28, and 52.
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up to 52 weeks
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Health Economics/Medical Resource Utilization Questionnaire (HE/MRU)
Time Frame: up to 52 weeks
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Health economic impact using the HE/MRU questionnaire will be assessed at baseline, Weeks 16, 28 and 52.
Patients will be asked to complete a HE/MRU questionnaire to collect information on demographics, medical insurances, and use of biologic agents and phototherapy.
Sections 1 and 2 are completed by the patient.
Sections 3 and 4 are completed by the physician.
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up to 52 weeks
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Change from baseline in productivity VAS at Weeks 16, 28, and 52
Time Frame: Baseline, Weeks 16, 28 and 52
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A 10 cm VAS will be used to assess work, school, or at home productivity.
Patients will be asked to put a single vertical line across the horizontal line at the spot that they feel best reflects the answer to the question, "How much has your disease affected your daily productivity at work, school or at home in the past 4 weeks?"
The score will be recorded as a measurement of the placement of the patient's mark on a 10 cm scale.
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Baseline, Weeks 16, 28 and 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
August 30, 2012
First Submitted That Met QC Criteria
August 31, 2012
First Posted (Estimate)
September 3, 2012
Study Record Updates
Last Update Posted (Estimate)
January 26, 2016
Last Update Submitted That Met QC Criteria
January 25, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100140
- CNTO1275PSO4016 (Other Identifier: Johnson & Johnson Pte Ltd)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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