Intratympanic Injection for Autoimmune Inner Ear Disease

NCT01526174 | Terminated Phase 1

• 2 other identifiers: HRI-002TNFalpha
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Serious Adverse Events

  Serious Adverse Events

  30 days

• Pure-tone threshold change

  Change in pure-tone threshold from baseline to 6 week after initiation of treatment

  6 weeks

Study Arms (2)

First Arm

EXPERIMENTAL

Determine safety of intratympanic injection

Drug: Golimumab

Second Arm

EXPERIMENTAL

Efficacy evaluation of 4 intratympanic injections

Drug: Golimumab

Interventions

Golimumab DRUG

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

Also known as: Simponi

First Arm; Second Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• House Research Institute: lead
• Janssen Services, LLC: collaborator

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Bilateral

Interventions

golimumab

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Derebery, MD

  House Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 3, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 14, 2013

Record last verified: 2013-10