NCT05590416

A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease

An Observational Study of Adalimumab in the Treatment of Acute Vogt-Koyanagi-Harada Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Tianjin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease

Detailed description

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the use of adalimumab, its potential risks and benefits. This is a monocenter, cohort, observational study evaluating patients with acute VKH divided into two groups: adalimumab therapy group and traditional therapy group. For adalimumab therapy group, an initial dose of 80 mg adalimumab was administered subcutaneously followed by a maintenance dose of 40 mg every two weeks, and data will be collected prospectively with regard to ophthalmologic outcomes. For the traditional therapy group, patients were treated with glucocorticoids alone or glucocorticoids combined with immunosuppressants. Study participants will be followed for up to one year to determine efficacy and side effects. According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, optical coherence tomography (OCT), change in corticosteroid dose during the study period and so on. The investigators evaluate the anti-inflammatory and immunosuppressive effects of adalimumab in treatment of acute VKH.

Conditions

• Vogt-Koyanagi-Harada Disease
• Adalimumab

Interventions

Type	Name	Description
DRUG	Adalimumab	Adalimumab is administered subcutaneously at an initial loading dose of 80 mg, followed by a 40 mg dose every other week (q2w) starting from the second week. Therapy will be continued 6 months after the disappearance of active ocular inflammation. Then, injection will extend for 3 days until withdrawal after 40 days apart.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-12-01
• Completion: 2024-12-30
• First posted: 2022-10-21
• Last updated: 2024-07-03

Locations

1 site across 1 country: China