Post-Marketing Surveillance Study of OTEZLA

Completed

• Conditions: Psoriasis

• Registration Number: NCT03284879
• Lead Sponsor: Amgen

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-31
• Study Start: 2017-09-05
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-15
• Primary Completion: 2021-10-31
• Study Completion: 2022-03-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1086

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tugi dermatology clinic; 🇯🇵 Kitakyushu, Fukuoka, Japan