Psoriasis
Conditions
Brief summary
Patient treatment preference and treatment satisfaction of physicians and patients comparing fumaric acid ester therapy with subsequent apremilast treatment
Interventions
DRUGPhase I: Fumaric acid esters. Phase II: Apremilast
Apremilast
Sponsors
Amgen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean absolute value of the overall TSQM score at week 24 of apremilast (APR) therapy (phase II). | 56 weeks |
Countries
Germany
Outcome results
None listed