Adult Non-infectious Uveitis
Conditions
Brief summary
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.
Interventions
Adalimumab 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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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; * The subject (including their partner) agrees to have no pregnancy or sperm donation plans during the entire trial period and for six months after the study concludes, and voluntarily adopts effective contraceptive measures; * Adult subjects with non-infectious uveitis who were prescribed TEBOV® adalimumab injection by physicians after a thorough risk/benefit assessment.
Exclusion criteria
* (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; * During the screening period or baseline visit, individuals with systemic inflammatory diseases requiring continued oral corticosteroid therapy or immunosuppressive treatment; * Infections requiring intravenous antimicrobial treatment within 30 days prior to the baseline visit, or infections requiring oral antimicrobial treatment within 14 days prior to the baseline visit; * Within 30 days prior to the baseline, an increase in the dose of other concomitant immunosuppressive therapy or failure to meet any of the following conditions: methotrexate (MTX) ≤25 mg/week; cyclosporine ≤4 mg/kg/day; mycophenolate (or equivalent dose of mycophenolic acid) ≤2 g/day; azathioprine ≤175 mg/day; tacrolimus oral ≤8 mg/day;Subjects who have received any live vaccine within 3 months prior to the first dose of Tadabow® Adalimumab injection, or who plan to receive live vaccines during the study;(7) Subjects currently participating in other clinical studies; * Subjects deemed unsuitable for participation in this trial by the investigator. * Within 90 days prior to baseline, intravitreal injection of anti Vascular Endothelial Growth Factor (VEGF) therapy (such as ranibizumab, aflibercept, or conbercept) has been administered; * Within 90 days prior to baseline, methotrexate was injected into the vitreous body for treatment; * Ozurdex implantation (dexamethasone implantation) was performed within 6 months prior to baseline; * Have received treatment with anti-tumor necrosis factor TNF or other potential therapeutic agents for uveitis within the past 6 months (excluding intravitreal injection of anti VEGF drugs); * After receiving the first dose of Taibowei ® Individuals who have received any live vaccine within the past 3 months prior to Adalimumab injection, or those who plan to receive a live vaccine during the study period; * Participants who are currently participating in other clinical studies; * Researchers believe that participants who are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of treatment failure in subjects | Week 6, week 24 | Time to treatment failure at week 6 or between weeks 6 and 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects meeting treatment failure criteria | Week 6, week 24 | 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 | Week 24 | 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 | Week 24 | 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+ | Week 24 | The proportion of subjects with a vitreous opacity (VH) grading of ≤0.5+ in both eyes at week 24 |
| The proportion of subjects whose best corrected visual acuity (BCVA) in both eyes has not deteriorated to ≥15 letters | Week 24 | In the Early Treatment Diabetic Retinopathy Study (ETDRS), the proportion of subjects whose best corrected visual acuity (BCVA) in both eyes did not deteriorate to ≥15 letters at week 24. |
| The proportion of subjects whose systemic corticosteroid dose is reduced to ≤7.5mg | Week 24 | The proportion of subjects whose systemic corticosteroid dose was reduced to ≤7.5mg at week 24. |
| Changes in Visual Function Questionnaire-25 (VFQ-25) | Week 6, week 24 | Changes in visual function questionnaire VFQ-25 at week 6 and week 24 |
| Incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious ADRs | Week 24 | Incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and serious ADRs. |
Countries
China
Contacts
CONTACTManli Li, Doctor
Outcome results
None listed