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

Sponsor
Tianjin Medical University
Study ID
NCT05590416
Status
Recruiting
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Conditions

  • Adalimumab
  • Vogt-Koyanagi-Harada Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    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.

Study Details

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

Key Dates

Start date
Jun 1, 2021
Status verified
Jul 2024
Primary completion
Dec 1, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: adalimumab group
    The initial dose of glucocorticoid is 1 mg/kg/day, and gradually stops within 90-180 days. 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.
  • Arm: traditional therapy group
    Acute VKH patients treatment with only glucocorticosteroid or glucocorticosteroid combined with immunosuppressive agents.

Primary Outcome Measure

Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit. [ Time Frame: 24 weeks ]

Central Contacts