Intratympanic Injection for Autoimmune Inner Ear Disease

Brief Title

Intratympanic Injection for Autoimmune Inner Ear Disease

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

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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Serious Adverse Events


Condition

Autoimmune Inner Ear Disease

Intervention

Golimumab

Study Arms / Comparison Groups

 First Arm
Description:  Determine safety of intratympanic injection

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

16

Start Date

March 2012

Completion Date

April 2014

Primary Completion Date

December 2013

Eligibility 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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Jennifer Derebery, MD, , 



Administrative Informations


NCT ID

NCT01526174

Organization ID

HRI-002

Secondary IDs

TNFalpha

Responsible Party

Sponsor

Study Sponsor

House Research Institute

Collaborators

 Janssen Services, LLC

Study Sponsor

Jennifer Derebery, MD, Principal Investigator, House Research Institute


Verification Date

October 2013