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OpenTrials
Completed

NCT Number: NCT03284879

Post-Marketing Surveillance Study of OTEZLA

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

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Key information

Conditions

Psoriasis Arthritis Arthritis, Psoriatic Behavior Behavioral Symptoms Body Weight Body Weight Changes Bone Diseases Cardiovascular Diseases Depression Digestive System Diseases Gastrointestinal Diseases Joint Diseases Musculoskeletal Diseases Neoplasms Pathological Conditions, Signs and Symptoms Self-Injurious Behavior Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Suicidal Ideation Suicide Vascular Diseases Vasculitis Weight Loss

Sex eligibility

All sexes

Study type

Observational

Primary location

Tugi dermatology clinic

Kitakyushu, Fukuoka, 804-0081, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Adverse Events (AEs)

    Time frame: Up to approximately 12 months

    Number of participants with adverse events

  2. General Improvement Rating

    Time frame: Approximately 1 year from administration

    General Improvement Rating will be assessed by physician's observation

  3. 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.

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

OTEZLA® Tablets Drug Use-Results Survey

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Sep 15, 2017
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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