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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Open Label Trial Open label, single arm trial of anakinra for corticosteroid-resistant Autoimmune Inner Ear Disease

Participant Flow:   Overall Study
    Open Label Trial
STARTED   12 [1] 
COMPLETED   10 [2] 
NOT COMPLETED   2 
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



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Corticosteroid-resistant AIED patients.

Reporting Groups
  Description
Single Arm Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment

Baseline Measures
   Single Arm 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      1   7.7% 
Between 18 and 65 years      12  92.3% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  46.2% 
Male      7  53.8% 
Race (NIH/OMB) [1] 
[Units: Participants]
Count of 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] 14 Non-responders, 1 elected not to participate
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      13 100.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures

1.  Primary:   To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease   [ Time Frame: 180 days ]

2.  Secondary:   Number of Serious Adverse Events Reported   [ Time Frame: 84 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: vambutas@nshs.edu


Publications of Results:

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