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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
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Andrea Vambutas, Northwell Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sensorineural Hearing Loss
Autoimmune Inner Ear Disease
Intervention Drug: Anakinra
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label Trial
Hide Arm/Group Description Open label, single arm trial of anakinra for corticosteroid-resistant Autoimmune Inner Ear Disease
Period Title: Overall Study
Started 12 [1]
Completed 10 [2]
Not Completed 2
Reason Not Completed
Adverse Event             2
[1]
Declined to participate. n=1 Did not receive intervention due to infeciton, n=1
[2]
Excluded from analysis, could not reach first milestone (day 28) for efficacy assessment, n=2
Arm/Group Title Single Arm
Hide Arm/Group Description Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
Corticosteroid-resistant AIED patients.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
1
   7.7%
Between 18 and 65 years
12
  92.3%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
13
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
[1]
Measure Description: 14 Non-responders, 1 elected not to participate
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
13
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease
Hide Description 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.
Time Frame 180 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm
Hide Arm/Group Description:
Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: responders
7
2.Secondary Outcome
Title Number of Serious Adverse Events Reported
Hide Description To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra
Time Frame 84 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Any subject enrolled in this study who received at least 1 injection dose of anakinra
Arm/Group Title Single Arm
Hide Arm/Group Description:
Subject who received at least one injection of anakinra
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: reported SAEs
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm
Hide Arm/Group Description Anakinra administered for 84 consecutive days
All-Cause Mortality
Single Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm
Affected / at Risk (%)
Total   10/12 (83.33%) 
Ear and labyrinth disorders   
Tinnitus  1  2/12 (16.67%) 
Eye disorders   
Visual Impairment  1 [1]  1/12 (8.33%) 
Gastrointestinal disorders   
Nausea  1  2/12 (16.67%) 
Nervous system disorders   
Headache  1  4/12 (33.33%) 
Vertigo  1  3/12 (25.00%) 
Respiratory, thoracic and mediastinal disorders   
Influenza like illness  1  1/12 (8.33%) 
Sinusitis  1  1/12 (8.33%) 
Wheezing  1  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
Injection site reactions  1 [2]  10/12 (83.33%) 
Cellulitis  1  1/12 (8.33%) 
Psoriasis Flare  1  1/12 (8.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
[1]
floaters
[2]
Injection site reactions
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Andrea Vambutas, MD, FACS
Organization: North Shore-LIJ Health System
Phone: 718-470-7748
Responsible Party: Andrea Vambutas, 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 Submitted: December 28, 2010
First Posted: December 29, 2010
Results First Submitted: September 16, 2014
Results First Posted: April 6, 2015
Last Update Posted: January 10, 2018