A PHASE 4 MULTICENTER SINGLE-ARM OPENLABEL STUDY TO EVALUATE THE IMPACT OF APREMILAST (CC-10004) ON MRI OUTCOMES IN SUBJECTS WITH PSORIATIC ARTHRITIS

Brief description of study

The purpose of the study is to see how safe and effective a drug called apremilast is for people with psoriatic arthritis (PsA) and to look at the changes in magnetic resonance imaging (MRI) scans over the duration of using the study drug. This study will also test how well your body tolerates apremilast and how successfully apremilast treats your disease. Research in the laboratory and previous studies in humans have shown that apremilast is effective in treating PsA by preventing specific reactions in your body that are caused by abnormal levels of inflammation. Apremilast may therefore improve the signs and symptoms of PsA. regimen for at least 3 months prior to baseline. In addition, the stable doses of MTX, 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: s19-00380
ClinicalTrials.gov Identifier: NCT03783026
Principal Investigator: Soumya M Reddy
Currently Recruiting

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