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OpenTrials
Completed

NCT Number: NCT02954081

APremilast After FumaRic Acid Ester Treatment

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

Completed

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site

Hamburg, 20354, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Phase I: Fumaric acid esters. Phase II: Apremilast

Drug

Apremilast

Primary outcomes

  1. Mean absolute value of the overall TSQM score at week 24 of apremilast (APR) therapy (phase II).

    Time frame: 56 weeks

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

Real-world Benefit of Apremilast Treatment of Patients With Moderate-to-severe Psoriasis After Transition From Fumaric Acid Esters

Acronym: APART

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2016
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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