Intratympanic Injection for Autoimmune Inner Ear Disease
Status:
Terminated
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
The investigators plan to conduct an open-label intratympanic injection proof-of-concept
trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients
with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm
approach. First, the investigators propose to dose 3 individual subjects with a single
intratympanic injection of golimumab and follow each for 30 days, closely examining them for
adverse events. If there are no serious adverse events, with FDA approval, the investigators
propose to dose 14 subjects, each with 4 intratympanic injections of golimumab.