A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease
An Observational Study of Adalimumab in the Treatment of Acute Vogt-Koyanagi-Harada Disease
Tianjin Medical University
15 participants
Jun 1, 2021
OBSERVATIONAL
Conditions
Summary
This project is designed to test the hypothesis that adalimumab is clinically useful for patients with acuta Vogt-Koyanagi-Harada disease
Eligibility
Inclusion Criteria6
- 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).
Exclusion Criteria6
- Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV).
- Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
- Subject has previous exposure to anti-tumor necrosis factor (TNF) therapy or any biologic therapy with a potential therapeutic impact on non-infectious uveitis.
- Subject has received Ozurdex® (dexamethasone implant) within 6 months prior to the Baseline visit.
- Subject has received intravitreal anti-VEGF therapy within 45 days of the Baseline visit for Lucentis® (ranibizumab) or Avastin® (bevacizumab) or within 60 days of the Baseline visit for anti-VEGF Trap (aflibercept).
- Subject has received intravitreal methotrexate within 90 days prior to the Baseline visit.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05590416