CClinicalTrials.gg
CompletedNCT03284879Updated Sep 8, 2025

Post-Marketing Surveillance Study of OTEZLA

An observational study in Psoriasis, sponsored by Amgen. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Amgen · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,086
Sex
All
01

Study 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
02

Conditions studied

  • Psoriasis

Keywords

  • Psoriasis vulgaris
  • Psoriasis arthropathica
  • Serious infections
  • Gastrointestinal Disorders
  • Serious Hypersensitivity
  • Weight Decrease
  • Vasculitis
  • Malignancies
  • Depression and Suicidal Ideation
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

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

Exclusion Criteria:

  • N/A
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,086 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with PsV and PsA treated with OTEZLA Tablets

    Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets

05

What researchers measure

Primary outcomes

  1. Adverse Events (AEs)

    Number of participants with adverse events

    Time frame: Up to approximately 12 months

  2. General Improvement Rating

    General Improvement Rating will be assessed by physician's observation

    Time frame: Approximately 1 year from administration

  3. General health assessment on VAS

    Visual Analog Scale (VAS) pain will be used for psoriatic arthritis patients' assessment.

    Time frame: Approximately 1 year from administration

  4. Changes in physician general assessment

    PGA: assessment for psoriatic vulgaris by physician to classify disease activity in a consistent manner

    Time frame: Approximately 1 year from administration

  5. 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

    Time frame: Approximately 1 year from administration

  6. Change from baseline activity for arthritis

    Activity for arthritis Baseline is calculated by Disease Activity Score-DAS28 method

    Time frame: Approximately 1 year from administration

06

Study locations

1 site
  • Tugi dermatology clinic
    Kitakyushu, Fukuoka 804-0081, Japan
07

References and documents

Publications

  • Ohtsuki M, Okubo Y, Saeki H, Igarashi A, Imafuku S, Abe M, Chaudhari S, Yaguchi M, Emoto A, Morita A. Safety and effectiveness of apremilast in Japanese patients with psoriatic disease: Results of a post-marketing surveillance study. J Dermatol. 2024 Jul;51(7):950-963. doi: 10.1111/1346-8138.17270. Epub 2024 May 22. PubMed 38775204 ↗
  • Ohtsuki M, Okubo Y, Saeki H, Igarashi A, Imafuku S, Abe M, Saito K, Ogawa R, Morita A. Clinical Characteristics and Safety Profiles of Japanese Psoriasis Patients Who Continued Apremilast Treatment for 6 and 12 Months: A Post Hoc Analysis of an Apremilast Postmarketing Surveillance Study. J Dermatol. 2025 Jun;52(6):1059-1065. doi: 10.1111/1346-8138.17764. Epub 2025 May 10. PubMed 40346955 ↗

Individual participant data

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

Supporting information: Study protocol, Sap, Icf, Csr

08

Registry details

Key details

Study ID
NCT03284879
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Sep 5, 2017
Primary completion
Oct 31, 2021
Completion
Mar 20, 2022
Last update
Sep 8, 2025

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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