Last updated on May 2020

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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Malcom Randall VA Medical Center

Gainesville, FL United States
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Johns Hopkins University

Baltimore, MD United States
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NYU Langone Medical Center

New York, NY United States
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Austin Regional Clinic

Austin, TX United States
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Swedish Medical Center

Seattle, WA United States
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UZ Leuven

Leuven, Belgium
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Frederiksberg Hospital

Frederiksberg, Denmark
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LLC Medical Center Zdorovaya Semiya

Novosibirsk, Russian Federation
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Kantonsspital St. Gallen

St. Gallen, Switzerland
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Recruitment Status: Open

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