A Randomized, Placebo-controlled, Multicenter, Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis (UP-SPOUT)

NCT06454188 Phase 4 RECRUITING

A Randomized, Placebo-controlled, Multicenter, Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients with Active Psoriatic Arthritis (UP-SPOUT)

Details

Lead sponsor	CARE ARTHRITIS LTD.
Phase	Phase 4
Status	RECRUITING
Enrolment	100
Start date	2024-12-03
Completion	2028-10

Conditions

• Psoriatic Arthritis
• Spondyloarthritis, Axial

Interventions

• Upadacitinib 15 MG [Rinvoq]
• Placebo

Primary outcomes

• Change from baseline in the (SPARCC) MRI inflammation score (for SIJ and spine) at 12 weeks of therapy with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup — 12 weeks

Countries

United States, Canada