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

February 1, 2012
October 10, 2013
March 2012
December 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01526174 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intratympanic Injection for Autoimmune Inner Ear Disease
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autoimmune Inner Ear Disease
Drug: Golimumab
Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections
Other Name: Simponi
  • Experimental: First Arm
    Determine safety of intratympanic injection
    Intervention: Drug: Golimumab
  • Experimental: Second Arm
    Efficacy evaluation of 4 intratympanic injections
    Intervention: Drug: Golimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
April 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01526174
HRI-002, TNFalpha
No
House Research Institute
House Research Institute
Janssen Services, LLC
Principal Investigator: Jennifer Derebery, MD House Research Institute
House Research Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP