Clinical trial · Observational
Post-Marketing Surveillance Study of OTEZLA
OTEZLA® Tablets Drug Use-Results Survey
NCT03284879CI-TRIAL-00094662completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psoriasis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Patients with PsV and PsA treated with OTEZLA Tablets
- description
- Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets
Primary outcomes (6)
- measure
- Adverse Events (AEs)
- timeFrame
- Up to approximately 12 months
- description
- Number of participants with adverse events
- measure
- General Improvement Rating
- timeFrame
- Approximately 1 year from administration
- description
- General Improvement Rating will be assessed by physician's observation
- measure
- General health assessment on VAS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDOhtsuki 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. PMID 38775204
- BACKGROUNDOhtsuki 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. PMID 40346955