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APremilast After FumaRic Acid Ester Treatment (APART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02954081
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date November 1, 2016
First Posted Date November 3, 2016
Last Update Posted Date April 29, 2020
Actual Study Start Date January 31, 2017
Estimated Primary Completion Date May 27, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 1, 2016)
Mean absolute value of the overall TSQM score at week 24 of apremilast (APR) therapy (phase II). [ Time Frame: 56 weeks ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title APremilast After FumaRic Acid Ester Treatment
Official Title Real-world Benefit of Apremilast Treatment of Patients With Moderate-to-severe Psoriasis After Transition From Fumaric Acid Esters
Brief Summary Patient treatment preference and treatment satisfaction of physicians and patients comparing fumaric acid ester therapy with subsequent apremilast treatment
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population
  • Adult patients ≥18 years
  • Moderate to severe plaque-type psoriasis according to SmPC
Condition Psoriasis
Intervention Drug: Phase I: Fumaric acid esters. Phase II: Apremilast
Apremilast
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 1, 2016)
1600
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 27, 2022
Estimated Primary Completion Date May 27, 2022   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02954081
Other Study ID Numbers CC-10004-PSOR-024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Amgen
Study Sponsor Amgen
Collaborators Not Provided
Investigators
Study Director: MD Amgen
PRS Account Amgen
Verification Date April 2020