Non-infectious uveitis
Conditions
Interventions
Experimental group:Subcutaneous adalimumab administration every three weeks
Control Group:Subcutaneous adalimumab administration every two weeks
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any NIU patients regardless of the cause or anatomical location; 2. ADA is administered every two weeks for more than 3 months without any serious adverse events reported; 3. Inflammation has been continuously alleviated for more than 3 months; 4. The baseline ADA trough concentration is >= 5.0 µg/ml; 5. The refractive media and pupil do not affect the eye examination and imaging tests; 6. The patient or the legal guardian (if the patient is under 18 years old) signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. General Conditions: 1) Complicated with systemic autoimmune disease, and relevant department assessment indicates that adjustment of the ADA treatment regimen is inappropriate; 2) Female patients who are pregnant or breastfeeding, or have a plan for pregnancy during the study period; 3) Evidence of past, active, or latent tuberculosis, syphilis, HIV, HBV, HCV, or other infections; 4) Presence of severe systemic diseases that may compromise safety, including but not limited to: severe infections requiring systemic antibiotic therapy, uncontrolled hypertension, cardiac insufficiency, renal insufficiency (undergoing hemodialysis or peritoneal dialysis), history of acute cardiovascular or cerebrovascular events, post-major organ transplantation, malignant tumors, mental disorders, etc.; 5) Receipt of blood transfusion within 12 months prior to screening; 6) Receipt of any type of live vaccine within 3 months prior to screening. 2. Ocular Medication (Either Eye): 1) Use of glucocorticoid eye drops >3 drops/day within 2 weeks prior to Day 1 (dose reduction or discontinuation is permitted during the study); 2) Receipt of subconjunctival injection of dexamethasone or other equivalent glucocorticoids within 1 month prior to Day 1; 3) Receipt of periocular injection of methylprednisolone within 2 months prior to Day 1; 4) Receipt of subconjunctival, periocular, intravitreal, or suprachoroidal injection of triamcinolone acetonide within 2 months prior to Day 1; 5) Receipt of intravitreal dexamethasone implant within 4 months prior to Day 1; 6) Receipt of intravitreal fluocinolone acetonide implant within 3 years prior to Day 1; 7) Receipt of intravitreal anti-VEGF injection within 2 months prior to Day 1; 8) Receipt of intravitreal methotrexate injection within 4 months prior to Day 1; 9) Receipt of intravitreal faricimab or other biologics injection within 4 months prior to Day 1. 3. Systemic Medication: 1) Use of systemic glucocorticoids at a dose greater than oral prednisone 10 mg/day or equivalent within 2 weeks prior to Day 1; 2) Increase in dose, addition, or switch of systemic conventional immunosuppressants within 2 weeks prior to Day 1; 3) Use of other TNF-a antagonists (e.g., infliximab, etanercept, golimumab, certolizumab pegol) or biologics targeting other pathways within 5 half-lives prior to Day 1; 4) Anticipated increase in dose of systemic glucocorticoids and/or conventional immunosuppressants, or addition/switch of conventional immunosuppressants and/or biologics during the study period (dose reduction or discontinuation of concomitant systemic medications is permitted during the study); 5) Use of any tumor immunotherapy, systemic anti-VEGF therapy, or drugs known to be toxic to the lens, retina, optic nerve, or associated with macular edema (including but not limited to deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, isoniazid, ethambutol, fingolimod, etc.) within 6 months prior to Day 1. 4. Ocular Conditions (Either Eye): 1) Receipt or planned receipt of ocular laser treatments (e.g., phototherapeutic keratectomy, laser peripheral iridotomy, laser posterior capsulotomy, retinal photocoagulation) within 1 month prior to Day 1 or during the study period; 2) Receipt or planned receipt of intraocular surgeries (e.g., refractive surgery, glaucoma surgery [minimally invasive, filtering, cyclodestructive procedures, etc.], cataract surgery, vitreoretinal surgery) within 3 months prior to Day 1 or during the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate of uveitis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event reporting rate;Economic burden of adalimumab; | — |
Countries
China
Contacts
Public ContactMeifen Zhang
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed