AIED: Intratympanic Injection for Autoimmune Inner Ear Disease

Sponsor

House Research Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT01526174

Collaborator

Janssen Services, LLC (Industry)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Inner Ear Disease	Drug: Golimumab	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Intratympanically Delivered Golimumab for Stabilization of Hearing in Patients With Autoimmune Inner Ear Disease: An Open-label Proof-of-concept Clinical Trial

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: First Arm Determine safety of intratympanic injection	Drug: Golimumab Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections Other Names: Simponi
Experimental: Second Arm Efficacy evaluation of 4 intratympanic injections	Drug: Golimumab Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections Other Names: Simponi

Arm

Intervention/Treatment

Experimental: First Arm

Determine safety of intratympanic injection

Drug: Golimumab

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

Other Names:

Simponi

Experimental: Second Arm

Efficacy evaluation of 4 intratympanic injections

Drug: Golimumab

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

Other Names:

Simponi

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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