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NCT03284879 Clinical Trial

Post-Marketing Surveillance Study of OTEZLA

Psoriasis Clinical Trial

Official title:
OTEZLA® Tablets Drug Use-Results Survey

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03284879
Other study ID # CC-10004-PSOR-018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 5, 2017
Est. completion date March 20, 2022

Study information
Verified date April 2022
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 1086
Est. completion date March 20, 2022
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Tugi dermatology clinic Kitakyushu Fukuoka

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

Japan, 

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