APremilast After FumaRic Acid Ester Treatment (APART)

Amgen

Status: Completed

Conditions: Psoriasis

Treatments: Drug: Phase I: Fumaric acid esters. Phase II: Apremilast

Study type: Observational

Funder types: Industry

Identifiers

NCT02954081

CC-10004-PSOR-024

Details and patient eligibility

About

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

Enrollment: 687 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)