A Study to Evaluate Ustekinumab in Patients With Plaque Psoriasis in Asia-Pacific Countries (MARCOPOLO)
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Details and patient eligibility
About
The purpose of this study is to determine how patients use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries.
Full 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.
Enrollment
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Volunteers
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
Trial design
169 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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