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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PsV and PsA treated with OTEZLA Tablets | Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Number of participants with adverse events | Up to approximately 12 months |
| General Improvement Rating | General Improvement Rating will be assessed by physician's observation | Approximately 1 year from administration |
| General health assessment on VAS | Visual Analog Scale (VAS) pain will be used for psoriatic arthritis patients' assessment. | Approximately 1 year from administration |
| Changes in physician general assessment | PGA: assessment for psoriatic vulgaris by physician to classify disease activity in a consistent manner | Approximately 1 year from administration |
| 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 | Approximately 1 year from administration |
| Change from baseline activity for arthritis | Activity for arthritis Baseline is calculated by Disease Activity Score-DAS28 method | Approximately 1 year from administration |
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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.
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tugi dermatology clinic | Kitakyushu | Fukuoka | 804-0081 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38775204 | Background | 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. | |
| 40346955 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| D005767 | Gastrointestinal Diseases |
| D015431 | Weight Loss |
| D014657 | Vasculitis |
| D009369 | Neoplasms |
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D025242 | Spondylarthropathies |
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| 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. |
| Expanded Access for CC-10004 | View source |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D004066 | Digestive System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |