A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
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ClinicalTrials.gov Identifier: NCT01267994 |
Recruitment Status
:
Completed
First Posted
: December 29, 2010
Results First Posted
: April 6, 2015
Last Update Posted
: January 10, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sensorineural Hearing Loss Autoimmune Inner Ear Disease | Drug: Anakinra | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Open-label Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Single Arm-Open Label
Single Arm-Open Label use of Anakinra
|
Drug: Anakinra
100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.
Other Name: Kineret
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- To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease [ Time Frame: 180 days ]The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.
- Number of Serious Adverse Events Reported [ Time Frame: 84 days ]To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra

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Ages Eligible for Study: | 13 Years to 75 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Bilateral sensorineural hearing loss with an active decline in hearing in one ear
- No audiometric improvement with 28-30 days of oral prednisone or other corticosteroid, including an initial dose of 60mg per day for 14 days
- Enrollment within 14 days of completion of corticosteroid therapy
- Age 13 years and older
- No evidence of neutropenia (low white blood cell count)
- No evidence of retrocochlear pathology (ie. acoustic neuroma/vestibular schwannoma)
- May have concurrent, systemic autoimmune disease
Exclusion Criteria:
- Age over 75, or less than 13
- Neutropenia
- Renal insufficiency
- Pregnant females
- Unilateral hearing loss
- Patients with any immunodeficiency syndrome
- Patients receiving methotrexate or any TNF (tumor necrosis factor) antagonist therapy
- Patients with chronic infections
- Patients treated for a malignancy within the past 3 years
- Patients with a latex allergy
- Patients with an inner ear anomaly
- Patients with retrocochlear pathology

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267994
United States, New York | |
North Shore-LIJ Hearing and Speech Center | |
New Hyde Park, New York, United States, 11040 |
Principal Investigator: | Andrea Vambutas, MD | Northwell Health |
Additional Information:
Publications of Results:
Responsible Party: | Andrea Vambutas, Professor of Otolaryngology & Molecular Medicine, Northwell Health |
ClinicalTrials.gov Identifier: | NCT01267994 History of Changes |
Other Study ID Numbers: |
1R21DC011827-01 ( U.S. NIH Grant/Contract ) R33DC011827 ( U.S. NIH Grant/Contract ) |
First Posted: | December 29, 2010 Key Record Dates |
Results First Posted: | April 6, 2015 |
Last Update Posted: | January 10, 2018 |
Last Verified: | December 2017 |
Keywords provided by Andrea Vambutas, Northwell Health:
Steroid Steroid-Resistant Autoimmune Inner Ear Disease Immune Mediated Hearing Loss |
Sudden Sensorineural Hearing Loss Meniere's Disease Autoimmune Hearing |
Additional relevant MeSH terms:
Hearing Loss Deafness Hearing Loss, Sensorineural Ear Diseases Labyrinth Diseases Labyrinthitis Hearing Disorders Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Otitis Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents |