Intratympanic Injection for Autoimmune Inner Ear Disease

NCT ID: NCT01526174

Last Updated: 2013-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-04-30

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.

Conditions

Autoimmune Inner Ear Disease

Keywords

autoimmune; hearing loss; bilateral hearing loss; steroid-dependent

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

First Arm

Determine safety of intratympanic injection

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: DRUG

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

Second Arm

Efficacy evaluation of 4 intratympanic injections

Group Type: EXPERIMENTAL

Golimumab

Intervention Type: DRUG

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

Interventions

Golimumab

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

Intervention Type: DRUG

Other Intervention Names

Simponi

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Services, LLC

INDUSTRY

Sponsor Role: collaborator

House Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Derebery, MD

Role: PRINCIPAL_INVESTIGATOR

House Research Institute

Countries

United States

Other Identifiers

TNFalpha

Identifier Type: OTHER

Identifier Source: secondary_id

HRI-002

Identifier Type: -

Identifier Source: org_study_id