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Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis | Clinical Trials | Clareo Health

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Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis

Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis (UP-FOR-U)

NCT07018206•CARE ARTHRITIS LTD.

View on ClinicalTrials.gov

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.

Detailed 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 for 52 weeks, with monthly remote visits and quarterly in-person visits. The primary objective is to evaluate the change in the exposure-adjusted incidence rate of ophthalmologist-confirmed AAU events per 100 patient-years during treatment, compared to the 52-week pre-study period. Secondary outcomes include measures of disease activity (e.g., ASDAS), physical function (e.g., BASFI), quality of life (e.g., ASAS-HI, SF-12), pain, sleep (e.g., PSQI), and safety (including adverse events, adverse events of special interest, and serious adverse events). This study reflects real-world clinical practice and incorporates remote data collection and patient-reported outcomes to improve feasibility and patient engagement. It is designed in accordance with ICH-GCP, FDA, Health Canada, and EMA regulatory requirements.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 ophthalmologist.
•6. Active disease as defined by a BASDAI value of ≥4 and TBP score of ≥4 (on a 0-10 NRS scale) at screening and baseline.
•7. History of an inadequate response to at least two different NSAIDs over a period of 4 weeks in total at the maximum recommended or tolerated doses, or intolerance/contraindication (e.g., allergic reaction, gastrointestinal symptoms or signs, severe arterial hypertension, etc.) for NSAIDs.
•8. Subjects must have been treated for ≥3 consecutive months prior to the study entry with bDMARD therapy and/or for ≥4 weeks of NSAID therapy, in accordance with local product label for AS or nr-axSpA, but continue to exhibit active SpA, or had to discontinue previous bDMARD and/or NSAID treatment due to intolerability or toxicity, irrespective of treatment duration. A total of 50 subjects who are bDMARD-naïve and 150 subjects who are b-DMARD-IR will be included in the study.
•9. For all females of child-bearing potential: must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug (local practices may require serum pregnancy testing at Baseline). Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥3 days later to document continued lack of a positive result (unless prohibited by local requirements).
•10. Subjects who are regularly taking NSAIDs or analgesics (including low potency opioids) as part of their axSpA therapy are required to be on a stable dose/dose regimen for at least 7 days prior to the baseline visit. If entering the study on concomitant tramadol, combination of acetaminophen/paracetamol and codeine or combination of acetaminophen/paracetamol and hydrocodone, and/or non-opioid analgesics, subject must be on stable dose(s) for at least 7 days prior to the baseline Visit. However, subject must not have used opioid analgesics (except for combination of acetaminophen/paracetamol and codeine or combination of acetaminophen/paracetamol and hydrocodone which are allowed) within 7 days prior to the BL Visit.
+3 more criteria

Exclusion Criteria

•1. 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.
•2. 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
•3. 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;
•4. 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.
•5. Primary or secondary immunodeficiency.
•6. Subjects with active TB or who meet TB exclusionary parameters (specific requirements for TB testing are provided in Section 7.0: TB Testing/TB Prophylaxis)
•7. Chronic infection with hepatitis B virus. At screening HBsAg and anti-HBc will be tested. Subjects who are HBsAg positive will be excluded. In case of HBsAg negativity, but anti-HBc positivity, participation in the study is possible if HBV-DNA testing is negative and no exclusionary liver function tests.
•8. Chronic infection with hepatitis C (HCV) (HCV ribonucleic acid (RNA) detectable in any subject with anti-HCV antibody (HCV Ab), or Human Immunodeficiency Virus (HIV) infection confirmed by positive HIV-antibody and antigen test.
•9. Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 4 weeks following the last dose of study drug.
•10. Subjects with chronic inflammatory articular disease (other than axSpA or systemic autoimmune diseases, e.g., systemic lupus erythematosus, Sjögren´s syndrome, RA, unequivocal chronic fatigue syndrome, or unequivocal fibromyalgia. Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease within 4 weeks prior to BL.
+14 more criteria

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

May 1, 2026

Primary Completion Date

May 1, 2027

Completion Date

May 1, 2027

Last Updated

February 6, 2026

Enrollment

200

ESTIMATED participants

Conditions

Axial Spondylarthritis (axSpA)

Interventions

Upadacitinib 15 MG [Rinvoq]

DRUG

Contacts

Jessica Restall-Pinder

CONTACT

5874009524 jessica.restall-pinder@carearthritis.com

Amanda Carapellucci

CONTACT

5874009524 amanda.carapellucci@carearthritis.com

A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib

NCT04846244

Axial Spondylarthritis (axSpA)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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