Post-Marketing Surveillance Study of OTEZLA

September 1, 2025 updated by: Amgen

OTEZLA® Tablets Drug Use-Results Survey

To evaluate the safety and efficacy of OTEZLA in actual clinical settings of use in patients with Psoriasis vulgaris that is with an inadequate response to topical therapies and Psoriasis arthropathica

  1. Planned registration period 2 years
  2. Planned surveillance period for 4 years from 6 months after launch

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1086

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

  • Japan
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 804-0081
        • Tugi dermatology clinic

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who have received a diagnosis of either of the following diseases and have received OTEZLA for the first time will be included in this survey.

  • Psoriasis vulgaris that is with an inadequate response to topical therapies
  • Psoriasis arthropathica

Description

Inclusion Criteria:

- Patients who have received a diagnosis of either of the following diseases and have received OTEZLA for the first time will be included in this survey.

  • Psoriasis vulgaris that is with an inadequate response to topical therapies
  • Psoriasis arthropathica

Exclusion Criteria:

  • N/A

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with PsV and PsA treated with OTEZLA Tablets
Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: Up to approximately 12 months
Number of participants with adverse events
Up to approximately 12 months
General Improvement Rating
Time Frame: Approximately 1 year from administration
General Improvement Rating will be assessed by physician's observation
Approximately 1 year from administration
General health assessment on VAS
Time Frame: Approximately 1 year from administration
Visual Analog Scale (VAS) pain will be used for psoriatic arthritis patients' assessment.
Approximately 1 year from administration
Changes in physician general assessment
Time Frame: Approximately 1 year from administration
PGA: assessment for psoriatic vulgaris by physician to classify disease activity in a consistent manner
Approximately 1 year from administration
Percentage of patients with Dermatology Life Quality Index (DLQI)
Time Frame: Approximately 1 year from administration
The Dermatology Life Quality Index or DLQI is a dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire
Approximately 1 year from administration
Change from baseline activity for arthritis
Time Frame: Approximately 1 year from administration
Activity for arthritis Baseline is calculated by Disease Activity Score-DAS28 method
Approximately 1 year from administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

September 5, 2017

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

March 20, 2022

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-10004-PSOR-018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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