APremilast After FumaRic Acid Ester Treatment

• Status: Active, not recruiting
• Trial end date: 2022-05-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen; Prof. Kristian Reich
• Treatments: Apremilast; Thalidomide

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)