Clinical Trials Logo
  1. Home
  2. Psoriasis
  3. NCT02954081
  4. Details
NCT02954081 Clinical Trial

APremilast After FumaRic Acid Ester Treatment

Psoriasis Clinical Trial

— APART  

Official title:
Real-world Benefit of Apremilast Treatment of Patients With Moderate-to-severe Psoriasis After Transition From Fumaric Acid Esters

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02954081
Other study ID # CC-10004-PSOR-024
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 26, 2017
Est. completion date August 15, 2022

Study information
Verified date January 2023
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 687
Est. completion date August 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Germany Site Hamburg

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean absolute value of the overall TSQM score at week 24 of apremilast (APR) therapy (phase II). 56 weeks
See also
  Status Clinical Trial Phase
Completed NCT03236870 - A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
Completed NCT00078819 - Etanercept (Enbrel®) in Psoriasis - Pediatrics Phase 3
Completed NCT04841187 - Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
Active, not recruiting NCT03927352 - The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis Phase 3
Completed NCT03284879 - Post-Marketing Surveillance Study of OTEZLA
Recruiting NCT06027034 - Effectiveness of a Digital Health Application for Psoriasis N/A
Not yet recruiting NCT06050330 - CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study N/A
Recruiting NCT05744466 - A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
Completed NCT04149587 - A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
Completed NCT01384630 - Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis Phase 2
Completed NCT03998683 - A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis Phase 3
Terminated NCT03556202 - A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3) Phase 3
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06077331 - A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis Phase 2
Completed NCT04316585 - A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants Phase 1
Completed NCT04894890 - A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Completed NCT00358384 - Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034 Phase 1
Completed NCT03757013 - A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
Completed NCT03265613 - Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis Phase 1/Phase 2
Completed NCT05003531 - A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis Phase 2

External Links