Refractory non-infectious uveitis
Conditions
Interventions
Control group:Conventional therapy plus placebo tablets of identical size, appearance and odor.
Conventional therapy is defined as any one or a combination of the following permitted treatments:
a. Or
b. Mycophenolate mofetil (1–1.5 g/day)
c. Azathioprine (1–2 mg/kg/day)
d. Methotrexate (7.5–15 mg/week).
The dosage must have remained stable for =4 weeks prior to enrollment, and no dose increase, decrease or agent switching shall be allowed throughout the entire trial
Treatment group:Subjects will be administered one tablet of upadacitinib orally once daily, while their pre-existing standard immunosuppressive and/or corticosteroid regimen (hereinafter referred to a
if more than 12 hours have passed, the missed dose shall be skipped.
Conventional Therapy permits any one or a combination of the following treatments:
? Oral corticosteroids (=20 mg/day)
? Mycophenolate mofetil (1–1.5 g/day)
? Azathioprine (1–2 mg/kg/day)
? Methotrexate (7.5–15 mg/week).
The dosage of Conventional Therapy must have remained stable for =4 weeks prior to study enrollment, and no dose adjustment, increase/decrease, or switching of therape
Sponsors
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older, male or female. 2. Meets the diagnostic criteria for non-infectious uveitis in accordance with the Standardization of Uveitis Nomenclature (SUN) classification system, and presents with active disease (SUN score >= 4 points: anterior chamber flare >= 1+, anterior chamber cells >= 1+, or vitreous haze >= 1+, or retinal vasculitis >= 1+). 3. Disease duration of 3 months or longer, with or without prior treatment with immunosuppressive agents or biological agents. 4. Best-corrected visual acuity (BCVA) of 20/200 or better (measured by Snellen visual acuity chart). 5. Normal hepatic and renal function (ALT and AST = 60 mL/min). 6. Negative results for T-SPOT.TB test, hepatitis B panel, hepatitis C antibody, and HIV antibody, with no evidence of active infection. 7. Voluntarily signs the written informed consent form and commits to complying with and completing the 24-week follow-up.
Exclusion criteria
Exclusion criteria: 1. Infectious uveitis (positive etiological test results for pathogens including bacteria, viruses, fungi, etc.). 2. Complicated by other ocular diseases such as glaucoma (intraocular pressure > 21 mmHg uncontrollable with medication) and cataract (lens opacity that severely impairs visual acuity assessment). 3. Past or current history of thrombosis, active peptic ulcer, or malignant tumor. 4. Female subjects who are pregnant, breastfeeding, or planning to conceive during the treatment period and within 3 months after drug withdrawal. 5. Hypersensitivity to upadacitinib, methotrexate, or their excipients. 6. Received live vaccination or participated in another clinical trial within 3 months prior to treatment initiation. 7. Complicated by severe cardiovascular diseases (e.g., heart failure, recent myocardial infarction).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect of reducing inflammation activity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anterior chamber cells;vision;Central retinal thickness, CRT; | — |
Countries
China
Contacts
Public ContactWenru Su
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed