UP-SPOUT

Impact of upadacitinib on axial inflammation and clinical outcomes in PsA

(Recruiting soon)

Type

Interventional - treatment

Purpose

Psoriatic arthritis (PsA) is a chronic inflammatory arthritis associated with substantial fatigue, pain, joint stiffness, and diminished function. It is reported that up to 70% of patients with long-standing PsA will demonstrate clinical and imaging features of axial inflammation. Treatment of this axial PsA (axPsA) is largely based on data in patients with axial SpA – there may be some overlap between these two diseases, but patients with axPsA may also have distinct features that require different treatment.

The purpose of this study is to evaluate the impact of Upadacitinib on axial inflammation and clinical outcomes in patients with axial PsA.

Participants will be randomized to receive either Upadacitinib 15mg daily or placebo for the first 12 weeks. After 12 weeks, those in the initial placebo arm will be moved onto active treatment for an additional 12 weeks.

Eligibility

At the University of Pennsylvania, we are only recruiting a certain sub-group of the larger study.

You may be eligible for this study if you:

• Are aged ≥18;
• Have been diagnosed with psoriatic arthritis; and
• Have back pain and evidence of axial inflammation on imaging.

Participation

Study participation will last approximately 34 weeks (up to 6 weeks of Screening, 24 weeks of treatment, and 4 weeks of safety follow-up). Initially, participants will be randomized to receive either Upadacitinib 15mg daily or placebo for the first 12 weeks. After 12 weeks, those in the initial placebo arm will be moved onto active treatment for the final 12 weeks.

You will be followed over the course of 6 months, with visits (including physical exam, blood draw, and questionnaires) every 4 weeks. You will have an MRI of your SI joints and spine at three timepoints – during Screening, Week 12, and Week 24.

You will receive compensation for your time at the study visits.