Intratympanic Injection for Autoimmune Inner Ear Disease (AIED)

This study has been terminated.
(House Research no longer conducting research.)
Sponsor:
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
House Research Institute
ClinicalTrials.gov Identifier:
NCT01526174
First received: February 1, 2012
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Autoimmune Inner Ear Disease
Drug: Golimumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by House Research Institute:

Primary Outcome Measures:
  • Serious Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Serious Adverse Events

  • Pure-tone threshold change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change in pure-tone threshold from baseline to 6 week after initiation of treatment


Enrollment: 16
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526174

Sponsors and Collaborators
House Research Institute
Janssen Services, LLC
Investigators
Principal Investigator: Jennifer Derebery, MD House Research Institute
  More Information

No publications provided

Responsible Party: House Research Institute
ClinicalTrials.gov Identifier: NCT01526174     History of Changes
Other Study ID Numbers: HRI-002, TNFalpha
Study First Received: February 1, 2012
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by House Research Institute:
autoimmune
hearing loss
bilateral hearing loss
steroid-dependent

Additional relevant MeSH terms:
Ear Diseases
Labyrinth Diseases
Labyrinthitis
Otorhinolaryngologic Diseases
Otitis

ClinicalTrials.gov processed this record on October 01, 2014