An Interventional Study of Upadacitinib Extended-Release Tablets in Patients With Refractory Uveitis
Condition(s) studied
Investigational drug(s) / intervention(s)
Upadacitinib Extended-Release Tablets: An interventional study of upadacitinib extended-release tablets (15 mg once daily) in patients with refractory uveitis.
Study summary
Upadacitinib sustained-release tablets have not yet been approved for the treatment of uveitis. The current use falls under the category of "off-label medication", which means providing patients with potentially beneficial treatment options in the absence of formal approval. Based on existing case reports and mechanism studies, we believe that upadacitinib sustained-release tablets have potential therapeutic value for patients with uveitis who have not responded well to traditional treatment regimens or those who have not responded well to traditional treatment combined with biologics (adalimumab). Therefore, we plan to conduct this clinical study to systematically evaluate its efficacy and safety in patients with refractory uveitis and explore better treatment options for these patients.
Eligibility
Primary outcome measure(s)
- Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Month 3, 6, 12 and 24. — From enrollment to the end of treatment at 24 months
Best-corrected visual acuity (BCVA) will be recorded as ETDRS letter scores converted from Snellen charts. BCVA will be measured at baseline, Month 3, Month 6, Month 12 and Month 24. The change in letter score from baseline will be calculated at each time-point to evaluate the effect of upadacitinib on subjects' visual function. - Change from Baseline in Anterior Chamber Cell Grade at Month 3, 6, 12 and 24 — From enrollment to the end of treatment at 24 months
Anterior chamber cell grade will be assessed by slit-lamp biomicroscopy following the SUN standardized uveitis grading criteria. Assessments will be performed at baseline, Month 3, Month 6, Month 12 and Month 24. Grade changes relative to baseline will be computed at each visit for longitudinal analysis of anterior-segment intraocular inflammation over treatment. - Change from Baseline in Vitreous Cell/Vitreous Haze Grade at Month 3, 6, 12 and 24. — 24 months from enrollment to treatment
Vitreous cell and vitreous haze will be graded by slit-lamp and indirect ophthalmoscopy using the Nussenblatt standardized scoring system. Evaluations will be conducted at baseline, Month 3, Month 6, Month 12 and Month 24. Grade changes versus baseline will be calculated at each time-point to assess the therapeutic response of vitreous inflammation to upadacitinib.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Tianjin Eye hospital | Tianjin | Tianjin Municipality |
More Tianjin Medical University trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07773623 on ClinicalTrials.gov ↗ ← All trials in China