NCT01677598

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 169 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	No intervention	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

Timeline

• Start date: 2011-12-02
• Primary completion: 2013-11-30
• Completion: 2013-11-30
• First posted: 2012-09-03
• Last updated: 2024-10-28

Locations

9 sites across 5 countries: Indonesia, Malaysia, Singapore, South Korea, Taiwan