Post-Marketing Surveillance Study of OTEZLA

OTEZLA® Tablets Drug Use-Results Survey

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03284879

Enrollment

1086

Registered

2017-09-15

Start date

2017-09-05

Completion date

2022-03-20

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis vulgaris, Psoriasis arthropathica, Serious infections, Gastrointestinal Disorders, Serious Hypersensitivity, Weight Decrease, Vasculitis, Malignancies, Depression and Suicidal Ideation

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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.
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

Countries

Japan

Outcome results