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Clinical Trial Summary

The aim of this study is to evaluate the efficacy and safety of corticosteroidcombining noncorticosteroid systemic immunomodulatory therapy (NCSIT) for the treatment of Vogt Koyanagi Harada disease (VKH).


Clinical Trial Description

Vogt Koyanagi Harada disease (VKH) is a sort of autoimmune disease directed against uveal melanocytes, which is a common vision-threatening noninfectious uveitis in colored people. VKH patients given prednisone monotherapy are prone to relapse. Noncorticosteroid systemic immunomodulatory therapy (NCSIT) demonstrated inflammation control and steroid-sparing effect in autoimmune diseases. Methotrexate as an antifolate metabolite has been widely used for its anti-inflammatory and immunomodulating properties. Adalimumab, humanized monoclonal anti-TNF-α antibody, have demonstrated the efficacy of noninfectious uveitis. Several randomized controlled trials have proved the efficacy and safety of NCSIT such as antimetabolite and biologics in non-infectious uveitis, while the optimal dose and treatment course remain unknown. The investigators propose to explore the effect, safety and optimal dose of prednisone combining NCSIT in the treatment of VKH. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05120687
Study type Observational
Source Sun Yat-sen University
Contact Dan Liang
Phone #86#-87330402
Email [email protected]
Status Recruiting
Phase
Start date October 15, 2021
Completion date October 6, 2025