Last updated on July 2019

A Study to Evaluate the Impact of Apremilast (CC-10004) on MRI Outcomes in Subjects With Psoriatic Arthritis


Brief description of study

This is a Phase 4, multicenter, single-arm, open-label study to evaluate the impact of apremilast, either in monotherapy or with stable Methotrexate (MTX), on Magnetic resonance imaging (MRI) outcomes in subjects with active PsA with up to 5 years of disease duration (since diagnosis).

Detailed Study Description

Approximately 120 subjects will receive apremilast 30 mg BID, after a 5-day titration period, with or without MTX. All subjects will be permitted to take NSAIDs and/or low-dose oral glucocorticoids (prednisone 10 mg/day or equivalent) throughout the study. The NSAIDs and low-dose oral glucocorticoids must be on a stable regimen for at least 4 weeks prior to baseline. MTX ( 25 mg/week) will be permitted if treatment duration is 6 months and on a stable regimen for at least 3 months prior to baseline. In addition, Nonsteroidal anti-inflammatory drug (NSAIDs), and low-dose glucocorticoids must be continued from Day 1 through the Week 24 Visit. Change in doses, increase or decrease, and/or discontinuation will not be allowed, except for safety reasons or for lack of availability. After the Week 24 Visit, the doses of MTX, NSAIDs, or glucocorticoids may be adjusted as clinically required.

Clinical Study Identifier: NCT03783026

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Frederiksberg Hospital

Frederiksberg, Denmark
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Copenhagen University Hospital Rigshospitalet

Glostrup Copenhagen, Denmark
4.37miles
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