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Tests treatment safety and results for Adult Non-infectious Uveitis
Official title A Multicenter, Open-label Study on the Efficacy and Safety of Tebiovio® (Adalimumab) in Treating Chinese Children With Severe Plaque Psoriasis
ClinicalTrials.gov ID: NCT07663331
What this study is testing
What is TyboWe® Adalimumab Injection?
TyboWe® Adalimumab Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for adult non-infectious uveitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a real-world clinical research on adalimumab. The project plans to enroll 30 subjects.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject must sign an informed consent form for data collection and data validation, and the research protocol/informed consent form must comply...
- 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...
- 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...
- 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...
You likely can't join if
- (Based on the instructions for Tymphul® Adalimumab Injection and the judgment of the treating physician, the subject is not suitable for treatment...
- The subject had any of the following ocular events during screening: isolated anterior uveitis; confirmed or suspected infectious uveitis; ocular...
- The subject has any of the following medical conditions or diseases: current or past history of demyelinating diseases (including multiple sclerosis...
- 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...
- Infections requiring intravenous antimicrobial treatment within 30 days prior to the baseline visit, or infections requiring oral antimicrobial...
See the full eligibility 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...
- 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...
- 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...
- Adult people with non-infectious uveitis who were prescribed TEBOV® adalimumab injection by physicians after a thorough risk/benefit assessment.
- (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...
- 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...
- 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...
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.