Trial record 2 of 501 for:
"Ear Diseases"
Intratympanic Injection for Autoimmune Inner Ear Disease (AIED)
This study is currently recruiting participants.
Verified April 2013 by House Research Institute
Sponsor:
House Research Institute
Collaborator:
Janssen Services, LLC
Information provided by (Responsible Party):
House Research Institute
ClinicalTrials.gov Identifier:
NCT01526174
First received: February 1, 2012
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Autoimmune Inner Ear Disease |
Drug: Golimumab |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by House Research Institute:
Primary Outcome Measures:
- 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
| Estimated Enrollment: | 17 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: First Arm
Determine safety of intratympanic injection
|
Drug: Golimumab
Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections
Other Name: Simponi
|
|
Experimental: Second Arm
Efficacy evaluation of 4 intratympanic injections
|
Drug: Golimumab
Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections
Other Name: Simponi
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01526174
Contacts
| Contact: Roberta Leyvas | 213-273-8025 | rleyvas@hei.org |
| Contact: Jennifer Derebery, MD | jderebery@hei.org |
Locations
| United States, California | |
| House Research Institute | Recruiting |
| Los Angeles, California, United States, 90057 | |
| Principal Investigator: Jennifer Derebery, MD | |
| Sub-Investigator: Michael Hoa, MD | |
Sponsors and Collaborators
House Research Institute
Janssen Services, LLC
Investigators
| Principal Investigator: | Jennifer Derebery, MD | House Research Institute |
More Information
No publications provided
| Responsible Party: | House Research Institute |
| ClinicalTrials.gov Identifier: | NCT01526174 History of Changes |
| Other Study ID Numbers: | HRI-002, TNFalpha |
| Study First Received: | February 1, 2012 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by House Research Institute:
|
autoimmune hearing loss bilateral hearing loss steroid-dependent |
Additional relevant MeSH terms:
|
Ear Diseases Labyrinth Diseases Labyrinthitis Otorhinolaryngologic Diseases Otitis |
ClinicalTrials.gov processed this record on June 17, 2013