Back to Search Results
Study Complete
Sponsor ID
CC-10004-PSOR-024

APremilast After FumaRic Acid Ester TreatmentAPART

Sponsor ID
CC-10004-PSOR-024
Clinicaltrials.gov ID
NCT02954081
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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

Additional Study Details

Phase
Phase 4
Product
N/A
Type
Observational
Masking
N/A
Enrollment
687
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: 56 weeks

Secondary Outcome Measures
Not Available

Locations

Location
Status
Contact Us
Location
Site
Hamburg, Germany, 20354
Status
Recruiting
Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Jan 2017 - Aug 2022
    Inclusion and Exclusion 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)