APremilast After FumaRic Acid Ester Treatment

Completed

• Conditions: Psoriasis

• Registration Number: NCT02954081
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-01
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Study Start: 2017-01-26
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 687

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean absolute value of the overall TSQM score at week 24 of apremilast (APR) therapy (phase II).	56 weeks

Trial Locations

Locations (1)

Site; 🇩🇪 Hamburg, Germany