NCT02954081

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
687

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 26, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

5.6 years

First QC Date

November 1, 2016

Last Update Submit

January 25, 2023

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

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

    56 weeks

Interventions

Phase I: Fumaric acid esters. Phase II: ApremilastDRUG

Apremilast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Adult patients ≥18 years * Moderate to severe plaque-type psoriasis according to SmPC

You may qualify if:

  • 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

You may not qualify if:

  • Prior treatment with biologics
  • According to SmPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site

Hamburg, 20354, Germany

Location

Related Links

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 3, 2016

Study Start

January 26, 2017

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

January 26, 2023

Record last verified: 2023-01

Locations

DE(1)