Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis (UP-FOR-U)
CARE ARTHRITIS LTD.
Summary
This is a Phase IV, open-label, multicenter study evaluating the impact of upadacitinib on the frequency of acute anterior uveitis (AAU) in adults with axial spondyloarthritis (axSpA) and a documented history of AAU in the prior 52 weeks. Approximately 200 participants will be enrolled across North America and Europe, including both biologic DMARD-inadequate responders (bDMARD-IR) and bDMARD-naïve patients. The primary objective is to assess the change in exposure-adjusted AAU event rate during 52 weeks of treatment with upadacitinib 15 mg once daily. Secondary objectives include evaluating the effect of upadacitinib on disease activity, pain, physical function, quality of life, and sleep. Safety and tolerability will also be assessed throughout the study.
Description
The UP-FOR-U study is a Phase IV, open-label, interventional study designed to assess the effect of upadacitinib 15 mg once daily on the frequency of acute anterior uveitis (AAU) in adult patients with axial spondyloarthritis (axSpA) and a history of ophthalmologist-confirmed AAU in the 52 weeks prior to baseline. The study will enroll approximately 200 participants across 20 sites in Canada, the United States, and the European Union, comprising both biologic DMARD-inadequate responders (bDMARD-IR) and bDMARD-naïve patients. All participants will receive open-label treatment with upadacitinib…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject ≥18 of age at the screening visit. 2. Subject must be able to understand and willing to adhere to all protocol requirements and voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. 3. Diagnosis of axSpA by their treating rheumatologist. 4. Classification of axSpA according to ASAS Classification Criteria 5. History of at least one acute anterior uveitis event in the 52 week period prior to baseline, diagnosed by an…
Interventions
- DrugUpadacitinib 15 MG [Rinvoq]
15mg tablet once per day
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania