PsoriasisNCT03284879
Post-Marketing Surveillance Study of OTEZLA
An observational study of Psoriasis, run by Amgen at 1 site in Japan.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- Type of treatment
- Pill or oral medicine
- How many people
- 1,086 participants
- Where
- 1 siteJapan
- Study dates
- 5 Sep 2017to 20 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OTEZLA® Tablets Drug Use-Results Survey
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
- Planned registration period 2 years
- Planned surveillance period for 4 years from 6 months after launch
- Conditions
- Psoriasis
- Keywords
- Psoriasis vulgaris, Psoriasis arthropathica, Serious infections, Gastrointestinal Disorders, Serious Hypersensitivity, Weight Decrease, Vasculitis, Malignancies, Depression and Suicidal Ideation
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic, Gastrointestinal Diseases, Weight Loss, Vasculitis, Neoplasms, Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PsV and PsA treated with OTEZLA Tablets | Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Number of participants with adverse events
Measured: Up to approximately 12 months
General Improvement Rating
General Improvement Rating will be assessed by physician's observation
Measured: Approximately 1 year from administration
General health assessment on VAS
Visual Analog Scale (VAS) pain will be used for psoriatic arthritis patients' assessment.
Measured: 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
Measured: 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
Measured: Approximately 1 year from administration
Change from baseline activity for arthritis
Activity for arthritis Baseline is calculated by Disease Activity Score-DAS28 method
Measured: Approximately 1 year from administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start5 Sep 2017
- Primary completion31 Oct 2021
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284879
- Sponsor's protocol ID
- CC-10004-PSOR-018
- Status last verified
- Sep 2025
- First submitted
- 31 Aug 2017
- Last updated
- 8 Sep 2025
- Results posted
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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 38775204Ohtsuki 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OTEZLA® Tablets Drug Use-Results Survey
- ClinicalTrials.gov ID
- NCT03284879
- Acronym / sponsor ID
- CC-10004-PSOR-018
- Conditions
- Psoriasis
- Keywords
- Psoriasis vulgaris, Psoriasis arthropathica, Serious infections, Gastrointestinal Disorders, Serious Hypersensitivity, Weight Decrease, Vasculitis, Malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,086 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Planned registration period 2 years
- Planned surveillance period for 4 years from 6 months after launch
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PsV and PsA treated with OTEZLA Tablets | – | –Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse Events (AEs)
Time frame: Up to approximately 12 months
Number of participants with adverse events
General Improvement Rating
Time frame: Approximately 1 year from administration
General Improvement Rating will be assessed by physician's observation
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.
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 38775204Ohtsuki 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.
- Background: PubMed 40346955Ohtsuki 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Expanded Access for CC-10004Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Amgen at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: Up to approximately 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03284879, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.