Intratympanic Injection for Autoimmune Inner Ear Disease

Phase 1

Terminated

• Conditions: Autoimmune Inner Ear Disease
• Interventions: Drug: Golimumab

• Registration Number: NCT01526174
• Lead Sponsor: House Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-03
• Study Start: 2012-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-14
• Primary Completion: 2013-12
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Diagnosis of autoimmune inner ear disease (AIED) by the principal investigator
• Idiopathic, bilateral sensorineural hearing loss
• History of, or audiograms showing, rapid progression of hearing loss
• Bilateral loss of at least 30 dB in one or more frequencies (0.25 - 6 kHz)
• Hearing responsive on high-dose oral steroids and steroid-dependent, as determined by history and the principal investigator. The subject can be taking oral steroid, at the maintenance level, if enrolled in the First Arm and, if enrolled in the Second Arm, will begin taper after the first injection.
• Provided written informed consent for participation in the clinical study

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Exclusion Criteria

• Positive MRI for vestibular schwannoma
• Positive FTA (syphilis)
• Significant middle ear disease (e.g., otitis media)
• Positive blood test for Lyme disease
• Positive tuberculosis test
• Concurrent or past treatment or use of medications and/or substances known to cause ototoxicity(for example, aminoglycosides [e.g., gentamicin], cisplatin, loop diuretics, Yorgason et al., 2006)
• Known adverse reaction to golimumab, adalimumab, etanercept, infliximab, rituximab, ustekinumab, or other biologic immunomodulators
• Concurrent (within the past 3 months prior to enrollment) live viral intranasal vaccine (flu)
• Positive test for HIV
• Positive test for Hepatitis B and C
• Presence of a demyelinating disease, such as multiple sclerosis
• Women of childbearing potential only: Positive serum pregnancy test prior to the only/first injection
• Active infections

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
First Arm	Golimumab	Determine safety of intratympanic injection
Second Arm	Golimumab	Efficacy evaluation of 4 intratympanic injections

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events	30 days	Serious Adverse Events
Pure-tone threshold change	6 weeks	Change in pure-tone threshold from baseline to 6 week after initiation of treatment