Randomized Study of Upadacitinib Versus Placebo for Treating Active Psoriatic Arthritis with Spondyloarthritis Features

What this Trial Is About

Researchers are evaluating the effects of Upadacitinib on spondyloarthritis outcomes in adults with active psoriatic arthritis. This randomized, placebo-controlled, multicenter study aims to understand how this treatment impacts inflammation and disease activity in patients who have shown inadequate response or intolerance to other treatments. The trial is sponsored by CARE ARTHRITIS LTD. and is in Phase 4. Participants will be randomly assigned to receive either Upadacitinib 15 mg tablets once daily or matching placebo tablets once daily, each for a duration of 12 weeks. The study compares these two groups to assess changes in MRI inflammation scores and disease activity measures. The trial uses quadruple masking to ensure unbiased results. During the study, participants will undergo assessments including MRI scans of the sacroiliac joints and spine, evaluations of disease activity scores such as the Ankylosing Spondylitis Disease Activity Score ASDAS-CRP and BASDAI, and monitoring of adverse events up to 28 weeks. Stable use of certain medications is required before baseline. The total participation duration spans from screening through the 12-week treatment period with follow-up for safety monitoring.

A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis