Intratympanic Injection for Autoimmune Inner Ear Disease (AIED)

House Research Institute

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Autoimmune Inner Ear Disease

Treatments

Drug: Golimumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01526174

HRI-002

TNFalpha (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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