Intratympanic Injection for Autoimmune Inner Ear Disease | NCT01526174

Studies
Intratympanic Injection for Autoimmune Inner Ear Disease

NCT01526174

Sponsor

House Research Institute

Status

Terminated

Last Update Posted

Oct 14, 2013Estimated

Enrollment

16Actual

Phase

Phase 1Phase 2

Conditions

Autoimmune Inner Ear Disease

Interventions

Golimumab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
TNFalpha	Other Identifier	House Research Institute

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

House Research no longer conducting research.

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Dec 2013Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

Feb 1, 2012

First Submission Date that Met QC Criteria

Feb 2, 2012

First Posted Date

Feb 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2013

Last Update Posted Date

Oct 14, 2013Estimated

Name	Class
Janssen Services, LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
First Arm	Experimental	Determine safety of intratympanic injection	Drug: Golimumab
Second Arm	Experimental	Efficacy evaluation of 4 intratympanic injections	Drug: Golimumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Golimumab	Drug	Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections	First Arm Second Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serious Adverse Events	Serious Adverse Events	30 days
Pure-tone threshold change	Change in pure-tone threshold from baseline to 6 week after initiation of treatment	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D034381	Hearing Loss
D006312	Hearing Loss, Bilateral

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders