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
Among 61 studies in Psoriasis by Amgen — 1 open to participants now, 1 under way, none of them phase 3. Psoriasis · Amgen.
Among the 61 studies in Psoriasis by Amgen, this one is the 2nd largest by enrollment of the 10 observational ones that give a count, is one of 4 that started in 2017, is one of 10 observational ones, and was the 43rd registered.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
Browse Psoriasis studies →1 of the 61 studies in Psoriasis by Amgen is open now. Recruiting first, the newest first:
Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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61 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 4 started in 2017.
This study's enrollment of 1,086 is above the median of 199 across 407 observational studies indexed under Psoriasis.
Median enrollment 250 across the 49 interventional studies, 422 across the 10 observational. Of the 60 that completed or were terminated, 35 (58%) have results posted.
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Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
1 of the studies in Psoriasis by Amgen that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07908641AmgenComparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation | 2027-01-10 |
Among the 61 studies in Psoriasis by Amgen, from their registry updates:
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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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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:
Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets
Adverse Events (AEs)
Number of participants with adverse events
Time frame: Up to approximately 12 months
General Improvement Rating
General Improvement Rating will be assessed by physician's observation
Time frame: Approximately 1 year from administration
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
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
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
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
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, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 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.
Access criteria: 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.
Data sharing details ↗ · www.amgen.com
Ran from Sep 2017 to primary completion in Oct 2021, 49 months.
Of 81 industry-sponsored observational studies under Psoriasis, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 74. This study's 49 months is above that.
Counting every sponsor, half of 173 studies reached it within 37 months; a quarter within 23 and three quarters within 93.
How these figures are worked out, and which studies are left out of them.
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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