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A Multicenter, Open-label Study on the Efficacy and Safety of Tebiovio® (Adalimumab) in Treating Chinese Children With Severe Plaque Psoriasis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Tianjin Medical University Eye Hospital
RECRUITING
Tianjin
Contact Information
Primary
Manli Li, Doctor
343507699@qq.com
15093292527
Time Frame
Start Date: 2026-07-14
Estimated Completion Date: 2028-02
Participants
Target number of participants: 30
Treatments
Experimental: TyboWe® Adalimumab Injection 40mg
The initial subcutaneous dose is 80mg, followed by 40mg subcutaneous injections every 2 weeks starting 1 week after the first administration.
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

This content was sourced from clinicaltrials.gov

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