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Intratympanic Injection for Autoimmune Inner Ear Disease

NCT01526174 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-10-14

No results posted yet for this study

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.

Conditions

  • Autoimmune Inner Ear Disease

Interventions

DRUG

Golimumab

Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections

Sponsors & Collaborators

  • Janssen Services, LLC

    collaborator INDUSTRY

  • House Research Institute

    lead OTHER

Principal Investigators

  • Jennifer Derebery, MD · House Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-12-31
Completion
2014-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526174 on ClinicalTrials.gov