This study is a real-world clinical research on adalimumab. The project plans to enroll 30 subjects. The safety and efficacy of adalimumab injection for adult non-infectious uveitis are being investigated. The time of treatment failure for subjects at 6 weeks of treatment or between 6 and 24 weeks of treatment is the primary endpoint.
The subject must sign an informed consent form for data collection and data validation, and the research protocol/informed consent form must comply with local legal and regulatory requirements;
Age 18 or above, gender unrestricted;
Diagnosed with active non-infectious intermediate, posterior, or panuveitis, defined as the presence of at least one of the following conditions in at least one eye: active, inflammatory chorioretinopathy and/or inflammatory retinal vasculitis; ≥2+ AC cells (according to the Standardization of Uveitis Nomenclature [SUN] criteria); or ≥2+ VH (National Eye Institute/SUN criteria);
The subject had received oral prednisone (or equivalent corticosteroid medication) at a dose of ≥10 mg to 60 mg/day for ≥2 weeks prior to screening and remained on the same dose at baseline, with corresponding documentation provided;
(Based on the instructions for Tymphul® Adalimumab Injection and the judgment of the treating physician, the subject is not suitable for treatment with Tymphul® Adalimumab Injection.);
The subject had any of the following ocular events during screening: isolated anterior uveitis; confirmed or suspected infectious uveitis; ocular masquerade syndrome, such as ocular lymphoma; ocular histoplasmosis syndrome; serpiginous choroidopathy; scleritis; corneal or lens opacity impairing fundus visualization or requiring cataract surgery during the trial; macular edema as the sole sign of uveitis; severe VH impairing fundus visualization at baseline; intraocular pressure ≥25 mmHg with use of ≥2 glaucoma medications or evidence of glaucomatous optic neuropathy; best-corrected visual acuity (BCVA) of less than 20 letters (ETDRS) in either eye at baseline; proliferative or severe nonproliferative diabetic retinopathy or clinically significant macular edema caused by diabetic retinopathy; neovascular (wet) age-related macular degeneration; vitreoretinal interface abnormalities (e.g., vitreomacular traction, epiretinal membrane, etc.) that may lead to macular structural damage unrelated to inflammatory processes; ocular surgery performed within 90 days prior to the baseline visit, excluding refractive laser surgery, retinal laser photocoagulation, or Yttrium Aluminum Garnet (YAG) (neodymium-doped yttrium-aluminum-garnet) posterior capsulotomy;
The subject has any of the following medical conditions or diseases: current or past history of demyelinating diseases (including multiple sclerosis and optic neuritis) or neurological symptoms indicative of demyelinating diseases, including but not limited to optic neuritis; current or past history of systemic lupus erythematosus; arrhythmia (QTc ≥450ms for males, QTc ≥470ms for females); moderate to severe congestive heart failure (New York Heart Association Class III-IV); recent cerebrovascular accident and any other medical history deemed by the investigator to pose a risk to the subject's participation in the study; any malignant tumor (except successfully treated non-melanoma skin cancer or localized cervical carcinoma in situ); any other clinically significant medical condition that the investigator deems to interfere with the subject's participation in the study or render the subject ineligible for the investigational drug, or any other reason;
Individuals allergic to the active ingredients (and their excipients) and/or similar products;
Single group
TyboWe® Adalimumab Injection
DrugAdalimumab is a fully human anti-tumour necrosis factor-alpha monoclonal antibody that inhibits the downstream inflammatory cascade by blocking Tumor Necrosis Factor (TNF) α, a core inflammatory factor in psoriasis.
Time of treatment failure in subjects
Time to treatment failure at week 6 or between weeks 6 and 24.
Proportion of subjects meeting treatment failure criteria
Proportion of subjects meeting the treatment failure criteria at week 6 and week 24
The proportion of subjects with inactive inflammatory choroidoretinitis and/or inflammatory retinal vasculopathy in both eyes
The proportion of subjects with inactive inflammatory choroidoretinitis and/or inflammatory retinal vasculopathy in both eyes at week 24 compared to the proportion of subjects with inactive inflammatory choroidoretinitis and/or inflammatory retinal vasculopathy in both eyes at baseline.
The proportion of subjects with anterior chamber (AC) cell grading of ≤0.5+ in both eyes
The proportion of subjects whose anterior chamber (AC) cell grading reached ≤0.5+ in both eyes at week 24.
The proportion of subjects with bilateral vitreous opacity (VH) grading of ≤0.5+
The proportion of subjects with a vitreous opacity (VH) grading of ≤0.5+ in both eyes at week 24
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