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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 : September 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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:

Contacts and Locations

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
Contact: Shigeru Minohara, Study manager +81-3-5224-0660 sminohara@celgene.com

Locations
Japan
Tugi dermatology clinic Recruiting
Kitakyushu, Fukuoka, Japan, 804-0081
Sponsors and Collaborators
Celgene
Investigators
Study Director: Kyoko Matsui Celgene
More Information

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03284879     History of Changes
Other Study ID Numbers: CC-10004-PSOR-018
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by Celgene:
Psoriasis vulgaris
Psoriasis arthropathica
Serious infections
Gastrointestinal Disorders
Serious Hypersensitivity
Weight Decrease
Vasculitis
Malignancies
Depression and Suicidal Ideation

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents