NCT03783026

A Study to Evaluate the Impact of Apremilast on Magnetic Resonance Imaging (MRI) Outcomes in Adults With Psoriatic Arthritis

A Phase 4, Multicenter, Single-Arm, Open-Label Study to Evaluate the Impact of Apremilast (CC-10004) on MRI Outcomes in Subjects With Active Psoriatic Arthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the efficacy of apremilast, either in monotherapy or with stable methotrexate, on imaging outcomes in adults with active psoriatic arthritis with less than 5 years of disease duration (since diagnosis), and who are naïve to biologic therapies.

Detailed description

This study consists of 3 phases: * Screening Phase - up to 4 weeks * Single-arm, Open-label Treatment Phase - Weeks 0 to 48 * Participants will receive apremilast 30 mg BID (after a 5-day titration period) for the entire duration of this phase. * MRI of the most affected hand and whole body MRI (WB-MRI) will be performed at weeks 0, 24, and 48. * The hand with the greater inflammatory burden of swollen joints and/or dactylitis will be considered as the most affected hand. If both hands are equally affected, the dominant hand will be designated as the index hand. * Observational Follow-up Phase - 4 Weeks * All participants who complete the study or discontinue early will participate in the 4-week Post-Treatment Observational Follow-up Phase.

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Apremilast	Tablets for oral administration

Timeline

• Start date: 2019-02-06
• Primary completion: 2021-10-26
• Completion: 2022-05-11
• First posted: 2018-12-20
• Last updated: 2025-02-21
• Results posted: 2022-12-19

Locations

36 sites across 11 countries: United States, Austria, Belgium, Canada, Denmark, Germany, Italy, Russia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study