The Efficacy and Safety of Adalimumab for Inflammatory Flare Prevention in Non-infectious Anterior Pediatric Uveitis With Peripheral Vascular Leakage Compared With Methotrexate, a RCT Study

Who is this study for? Patients with Uveitis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Children with anterior uveitis are prone to suffer from chronic recurrent course of intraocular inflammation and adverse effects of glucocorticosteroids (GCs) /immunomodulatory treatment (IMT) agents. The performance of adalimumab has been shown to be fairly favorable in treating refractory non-infectious uveitis. This study aims to assess the efficacy and safety of adalimumab for inflammatory flare prevention in non-infectious anterior pediatric uveitis with peripheral vascular leakage compared with methotrexate. Children weighed ≥ 30kg and aged between 4-16 years old with active chronic non-infectious anterior uveitis with peripheral retinal vascular leakage on ultra wildfield fluorescence fundus angiography (UWFFA) will be included. They will be treated with a predesigned inflammatory control regimen to reach inflammatory quiescence in 1 month. After that they will be treated with either MTX or adalimumab and regularly followed up for at least 6 months. The primary endpoint is treatment failure defined as any inflammatory fare with anterior chamber cell count grading increased from 0 to 1. Secondary endpoints are best corrected visual acuity (BCVA), inflammation parameters (keratic precipitates, vitreous haze grades), extent of vascular leakage, frequency of topical steroid eyedrops, systemic immunosuppressive drug load, and adverse events.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 16
Healthy Volunteers: No
View:

• Children with noninfectious uveitis aged between 4-16, weight ≥ 30kg.

• Uveitis resistant to well conducted topical steroid therapy for three months, or uveitis resistant to well conducted 0.1% prednisolone twice a day for one month

• Retina peripheral vascular leakage demonstrated by UWFFA at the time of inclusion.

Locations
Other Locations
China
Peking University Medical College Hospital
Recruiting
Beijing
Contact Information
Primary
Hang Song, MD
songhang_pumch@163.com
+86 15600612346
Backup
Meifen Zhang, MD
meifen_zhang@hotmail.com
+86 13681566748
Time Frame
Start Date: August 19, 2021
Estimated Completion Date: July 2023
Participants
Target number of participants: 50
Treatments
Experimental: Adalimumab
Adalimumab administered subcutaneously at 40mg every 2 weeks
Active Comparator: Methotrexate
Methotrexate given 10mg orally once a week.
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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