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

NCT ID: NCT01677598

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

169 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-02

Study Completion Date

2013-11-30

Brief Summary

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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

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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

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Plaque Psoriasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with plaque psoriasis

Patients with plaque psoriasis using ustekinumab in Asia-Pacific countries.

No intervention

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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CNTO 1275

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Jakarta Pusat, , Indonesia

Site Status

Johor Bahru, , Malaysia

Site Status

Pulau Pinang, , Malaysia

Site Status

Singapore, , Singapore

Site Status

Incheon, , South Korea

Site Status

Seongnam-Si, Gyeonggi-Do, , South Korea

Site Status

Seoul, , South Korea

Site Status

Suwon, , South Korea

Site Status

Taipei, , Taiwan

Site Status

Countries

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Indonesia Malaysia Singapore South Korea Taiwan

Other Identifiers

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CNTO1275PSO4016

Identifier Type: OTHER

Identifier Source: secondary_id

CR100140

Identifier Type: -

Identifier Source: org_study_id

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