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A Study to Evaluate Ustekinumab in Patients With Plaque Psoriasis in Asia-Pacific Countries — MARCOPOLO  

Plaque Psoriasis Clinical Trial

Official title:
A Study to Evaluate Ustekinumab in Clinical Practice in Patients With Plaque Psoriasis in Asia-Pacific Countries

Clinical Trial Summary

The purpose of this study is to determine how patients use ustekinumab (label-recommended or other/missed dose interval) in Asia-Pacific countries.

Clinical Trial 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01677598
Study type Observational
Source Johnson & Johnson Pte Ltd
Contact
Status Completed
Phase Phase 4
Start date December 2011
Completion date November 2013
View Details
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