An Observational Study of Adalimumab in the Treatment of Acute Vogt-Koyanagi-Harada Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY
This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
⁃ Subject is 18 to 70 years of age.
⁃ Subjects who do not have previous, active or latent tuberculosis (TB).
⁃ Subject must have Vogt-Koyanagi-Harada disease less than one month.
⁃ Subject who were previously treated with systemic glucocorticoid less than one week.
⁃ Subject meets at least 1 of the following criteria:
• patients who reject using systemic glucocorticoid because of the long-term side effects. 2)patients with other high-risk or systemic disease were limited by the use of glucocorticoid. 3)patients with a little reparation of retinal detachments after a week treatment with powerful systemic glucocorticoid(≥1mg/kg/day).
Locations
Other Locations
China
Tianjin Medical University Eye Hospital
RECRUITING
Tianjin
Contact Information
Primary
xiaomin zhang, M.D
xiaomzh@126.com
+86-13920023990
Time Frame
Start Date:2021-06-01
Estimated Completion Date:2024-12-30
Participants
Target number of participants:15
Treatments
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.
traditional therapy group
Acute VKH patients treatment with only glucocorticosteroid or glucocorticosteroid combined with immunosuppressive agents.