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Intratympanic Injection for Autoimmune Inner Ear Disease (AIED)

Primary Purpose

Autoimmune Inner Ear Disease

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Golimumab

About this trial

This is an interventional treatment trial for Autoimmune Inner Ear Disease focused on measuring autoimmune, hearing loss, bilateral hearing loss, steroid-dependent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

First Arm

Second Arm

Arm Description

Determine safety of intratympanic injection

Efficacy evaluation of 4 intratympanic injections

Outcomes

Primary Outcome Measures

Serious Adverse Events

Pure-tone threshold change

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01526174

First Posted

February 1, 2012

Last Updated

October 10, 2013

Sponsor

House Research Institute

Collaborators

Janssen Services, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01526174

Brief Title

Intratympanic Injection for Autoimmune Inner Ear Disease

Acronym

AIED

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 Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Terminated

Why Stopped

House Research no longer conducting research.

Study Start Date

March 2012 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

House Research Institute

Collaborators

Janssen Services, LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Inner Ear Disease

Keywords

autoimmune, hearing loss, bilateral hearing loss, steroid-dependent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

First Arm

Arm Type

Experimental

Arm Description

Determine safety of intratympanic injection

Arm Title

Second Arm

Arm Type

Experimental

Arm Description

Efficacy evaluation of 4 intratympanic injections

Intervention Type

Drug

Intervention Name(s)

Golimumab

Other Intervention Name(s)

Simponi

Intervention Description

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

Primary Outcome Measure Information:

Title

Serious Adverse Events

Description

Serious Adverse Events

Time Frame

30 days

Title

Pure-tone threshold change

Description

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Derebery, MD

Organizational Affiliation

House Research Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Intratympanic Injection for Autoimmune Inner Ear Disease

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