Status:
TERMINATED
Intratympanic Injection for Autoimmune Inner Ear Disease
Lead Sponsor:
House Research Institute
Collaborating Sponsors:
Janssen Services, LLC
Conditions:
Autoimmune Inner Ear Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01526174
Start Date
March 1 2012
End Date
April 1 2014
Last Update
October 14 2013
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