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.
Subject ≥18 of age at the screening visit.
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.
Diagnosis of axSpA by their treating rheumatologist.
Classification of axSpA according to ASAS Classification Criteria
Active infection(s) requiring treatment with parenteral anti-infectives within 30 days, or oral antiinfectives within 14 days prior to the baseline Visit; Chronic recurring infection and/or active viral infection that based on the investigator's clinical assessment makes the subject an unsuitable candidate for the study.
COVID-19: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status
Suspected COVID-19: subjects with signs/symptoms suggestive of COVID-19, known exposure, or high-risk behavior should undergo molecular (e.g., PCR) testing to rule out SARS-CoV-2 infection or must be asymptomatic for 5 days from a potential exposure;
History of recurrent (more than one episode) herpes zoster or disseminated/multi-dermatomal (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
Single group
Upadacitinib 15 MG [Rinvoq]
Drug15mg tablet once per day
Frequency of recurrent acute anterior uveitis (AAU)
To evaluate the impact of upadacitinib on the frequency of recurrent acute anterior uveitis (AAU) over 52 weeks in subjects with active axSpA and a prior AAU event in the 52 weeks prior to baseline, who are switching from bDMARD (North America and Europe), or who are NSAID-IR and bDMARD naïve (Europe), in real world practice.
Proportion of participants achieving low disease activity (ASDAS LDA) at Week 24
The percentage of participants achieving a score of less than 2.1 on the Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 24. ASDAS is a validated composite index that incorporates patient-reported outcomes and objective measures of inflammation to assess disease activity in axial spondyloarthritis.
Proportion of participants achieving ASAS Health Index (ASAS-HI) ≤5 at Week 52
The percentage of participants who achieve a score of 5 or less on the ASAS Health Index (ASAS-HI) at Week 52. The ASAS-HI is a validated patient-reported outcome measure that evaluates the impact of axial spondyloarthritis on physical function, pain, emotional well-being, and social participation. A score ≤5 indicates better health status and is considered a meaningful clinical threshold.
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