Post-Marketing Surveillance Study of OTEZLA

NCT ID: NCT03284879

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1086 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-05

Study Completion Date

2022-03-20

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with PsV and PsA treated with OTEZLA Tablets

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Tugi dermatology clinic

Kitakyushu, Fukuoka, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 38775204 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40346955 (View on PubMed)

Related Links

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Other Identifiers

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CC-10004-PSOR-018

Identifier Type: -

Identifier Source: org_study_id

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