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APremilast After FumaRic Acid Ester Treatment (APART)

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: NCT02954081
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
Patient treatment preference and treatment satisfaction of physicians and patients comparing fumaric acid ester therapy with subsequent apremilast treatment

Condition or disease Intervention/treatment
Psoriasis Drug: Phase I: Fumaric acid esters. Phase II: Apremilast

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Real-world Benefit of Apremilast Treatment of Patients With Moderate-to-severe Psoriasis After Transition From Fumaric Acid Esters
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : May 27, 2022
Estimated Study Completion Date : May 27, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis


Intervention Details:
  • Drug: Phase I: Fumaric acid esters. Phase II: Apremilast
    Apremilast


Primary Outcome Measures :
  1. Mean absolute value of the overall TSQM score at week 24 of apremilast (APR) therapy (phase II). [ Time Frame: 56 weeks ]


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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Adult patients ≥18 years
  • Moderate to severe plaque-type psoriasis according to SmPC
Criteria

Inclusion Criteria:

  • Adult patients ≥18 years
  • Moderate to severe plaque-type psoriasis according to SmPC
  • Phase I: Patients will be included once they are started on systemic fumaric acid esters (e.g. Fumaderm initial®) for the treatment of moderate-to-severe psoriasis vulgaris. Patients initiated on fumaric acid esters will be followed for a maximum of 24 weeks during phase I. Patients continued on fumaric acid esters beyond 24 weeks or switched to a therapy other than apremilast during or at the end of the 24-week phase I period will no longer be followed.
  • Phase II: Patients switched to apremilast during or at the end of the 24-week phase I period will be included in phase II and followed for additional 32 weeks.
  • Written informed consent

Exclusion Criteria:

  • Prior treatment with biologics
  • According to SmPC
  • Participation in another clinical trial (parallel inclusion in the National psoriasis registry PsoBest is allowed)

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): NCT02954081


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

Locations
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Germany
Site Recruiting
Hamburg, Germany, 20354
Contact: Investigator         
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: NCT02954081    
Other Study ID Numbers: CC-10004-PSOR-024
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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