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Intratympanic Injection for Autoimmune Inner Ear Disease (AIED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526174
Recruitment Status : Terminated (House Research no longer conducting research.)
First Posted : February 3, 2012
Last Update Posted : October 14, 2013
Janssen Services, LLC
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
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 : March 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Disorders
Drug Information available for: Golimumab

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 Name: 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 Name: Simponi

Primary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: 30 days ]
    Serious Adverse Events

  2. Pure-tone threshold change [ Time Frame: 6 weeks ]
    Change in pure-tone threshold from baseline to 6 week after initiation of treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526174

Sponsors and Collaborators
House Research Institute
Janssen Services, LLC
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Principal Investigator: Jennifer Derebery, MD House Research Institute
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Responsible Party: House Research Institute Identifier: NCT01526174    
Other Study ID Numbers: HRI-002
TNFalpha ( Other Identifier: House Research Institute )
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013
Keywords provided by House Research Institute:
hearing loss
bilateral hearing loss
Additional relevant MeSH terms:
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Ear Diseases
Labyrinth Diseases
Otorhinolaryngologic Diseases