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APremilast After FumaRic Acid Ester Treatment (APART)

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ClinicalTrials.gov Identifier: NCT02954081
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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

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 : December 31, 2019
Estimated Study Completion Date : December 31, 2020

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

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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
Contact: Laura Lopez Gomez 0049 40 55 44 01 - 0 ext 121 laura.lopez-gomez@sciderm.com
Contact: Alexander Schneede 0049 40 55 44 01 - 0 ext 143 alexander.schneede@sciderm.com

Locations
Germany
Site Recruiting
Hamburg, Germany, 20354
Contact: Investigator         
Sponsors and Collaborators
Celgene
Investigators
Principal Investigator: Kristian Reich Sciderm GmbH

Additional Information:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02954081     History of Changes
Other Study ID Numbers: CC-10004-PSOR-024
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
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
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents