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Post-Marketing Surveillance Study of OTEZLA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284879
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief 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

Condition or disease
Psoriasis

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: OTEZLA® Tablets Drug Use-Results Survey
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Group/Cohort
Patients with PsV and PsA treated with OTEZLA Tablets
Patients with psoriasis vulgaris and patients with psoriatic arthritis who are treated with OTEZLA Tablets



Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to approximately 12 months ]
    Number of participants with adverse events

  2. General Improvement Rating [ Time Frame: Approximately 1 year from administration ]
    General Improvement Rating will be assessed by physician's observation

  3. 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.

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284879


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Japan
Tugi dermatology clinic Recruiting
Kitakyushu, Fukuoka, Japan, 804-0081
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03284879    
Other Study ID Numbers: CC-10004-PSOR-018
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
URL: http://www.amgen.com/datasharing
Keywords provided by Amgen:
Psoriasis vulgaris
Psoriasis arthropathica
Serious infections
Gastrointestinal Disorders
Serious Hypersensitivity
Weight Decrease
Vasculitis
Malignancies
Depression and Suicidal Ideation
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases