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Trial Outcomes & Findings for A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease (NCT NCT01267994)

NCT ID: NCT01267994

Last Updated: 2018-01-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

180 days

Results posted on

2018-01-10

Participant Flow

Participant milestones

Participant milestones
Measure
Open Label Trial
Open label, single arm trial of anakinra for corticosteroid-resistant Autoimmune Inner Ear Disease
Overall Study
STARTED
12
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Open Label Trial
Open label, single arm trial of anakinra for corticosteroid-resistant Autoimmune Inner Ear Disease
Overall Study
Adverse Event
2

Baseline Characteristics

A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Single Arm
n=13 Participants
Patients with Autoimmune Inner Ear Disease that had \<5dB hearing improvement in response to corticosteorids following 28 days of treatment
Age, Categorical
<=18 years
1 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
13 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
13 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
13 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Single Arm
n=10 Participants
Patients with Autoimmune Inner Ear Disease that had \<5dB hearing improvement in response to corticosteorids following 28 days of treatment
To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease
7 responders

SECONDARY outcome

Timeframe: 84 days

Population: Any subject enrolled in this study who received at least 1 injection dose of anakinra

To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra

Outcome measures

Outcome measures
Measure
Single Arm
n=12 Participants
Patients with Autoimmune Inner Ear Disease that had \<5dB hearing improvement in response to corticosteorids following 28 days of treatment
Number of Serious Adverse Events Reported
0 reported SAEs

Adverse Events

Single Arm

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Single Arm
n=12 participants at risk
Anakinra administered for 84 consecutive days
Skin and subcutaneous tissue disorders
Injection site reactions
83.3%
10/12
Nervous system disorders
Headache
33.3%
4/12
Nervous system disorders
Vertigo
25.0%
3/12
Ear and labyrinth disorders
Tinnitus
16.7%
2/12
Respiratory, thoracic and mediastinal disorders
Influenza like illness
8.3%
1/12
Gastrointestinal disorders
Nausea
16.7%
2/12
Skin and subcutaneous tissue disorders
Cellulitis
8.3%
1/12
Respiratory, thoracic and mediastinal disorders
Sinusitis
8.3%
1/12
Respiratory, thoracic and mediastinal disorders
Wheezing
8.3%
1/12
Skin and subcutaneous tissue disorders
Psoriasis Flare
8.3%
1/12
Eye disorders
Visual Impairment
8.3%
1/12

Additional Information

Andrea Vambutas, MD, FACS

North Shore-LIJ Health System

Phone: 718-470-7748

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place