Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 5:39 PM
Study NCT ID:
NCT07018206
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis
Sponsor:
CARE ARTHRITIS LTD.
Organization:
Study Overview
Official Title:
Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis (UP-FOR-U)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UP-FOR-U
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: