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IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions (EASI ACL)

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ClinicalTrials.gov Identifier: NCT02930122
Recruitment Status : Terminated (Lack of funding)
First Posted : October 12, 2016
Results First Posted : October 27, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Cale Jacobs, PhD, University of Kentucky

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Anterior Cruciate Ligament Tear
Interventions Drug: anakinra (150mg)
Other: Saline intraarticularly
Enrollment 6
Recruitment Details  
Pre-assignment Details An insufficient number of participants were consented to generate meaningful data for this study as the study was terminated due to lack of funding.
Arm/Group Title Anakinra Placebo Control
Hide Arm/Group Description

Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury

anakinra (150mg): intraarticular administration

Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury

Saline intraarticularly: intraarticular administration

Period Title: Overall Study
Started 3 3
Completed 0 0
Not Completed 3 3
Reason Not Completed
The trial was terminated prior to participating completing the study due to lack of funding.             3             3
Arm/Group Title Arm 1 Placebo Control Total
Hide Arm/Group Description

Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury

anakinra (150mg): intraarticular administration

Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury

Saline intraarticularly: intraarticular administration

Total of all reporting groups
Overall Number of Baseline Participants 3 3 6
Hide Baseline Analysis Population Description
6 participants had been enrolled at the time the study was closed (3 participants in each group)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
<=18 years
3
 100.0%
1
  33.3%
4
  66.7%
Between 18 and 65 years
0
   0.0%
2
  66.7%
2
  33.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants
16
(16 to 17)
18
(14 to 21)
17
(14 to 21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
Female
2
  66.7%
0
   0.0%
2
  33.3%
Male
1
  33.3%
3
 100.0%
4
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  33.3%
0
   0.0%
1
  16.7%
White
2
  66.7%
3
 100.0%
5
  83.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 6 participants
3 3 6
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptom Score   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 3 participants 3 participants 6 participants
14
(10 to 16)
15
(11 to 15)
14.5
(10 to 16)
[1]
Measure Description: KOOS symptoms scores range from 0 to 100, with higher scores indicating less severe symptoms.
1.Primary Outcome
Title Change of Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptom Score Between Groups
Hide Description KOOS symptoms scores range from 0 to 100, with higher scores indicating less severe symptoms.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was terminated due to lack of funding so an insufficient number of participants were consented to generate meaningful data.
Arm/Group Title Arm 1 Placebo Control
Hide Arm/Group Description:

Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury

anakinra (150mg): intraarticular administration

Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury

Saline intraarticularly: intraarticular administration

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in CTX-II Levels From Injury to Time of Surgery
Hide Description CTX-II levels measured by ELISA
Time Frame time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was terminated due to lack of funding so an insufficient number of participants were consented to generate meaningful data.
Arm/Group Title Anakinra Placebo Control
Hide Arm/Group Description:

Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury

anakinra (150mg): intraarticular administration

Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury

Saline intraarticularly: intraarticular administration

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Other Pre-specified Outcome
Title MRI T1rho Changes
Hide Description MRI: T1rho values in Medial and lateral femoral condyle as well as medial and lateral tibial plateau
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was terminated due to lack of funding so an insufficient number of participants were consented to generate meaningful data.
Arm/Group Title Anakinra Placebo Control
Hide Arm/Group Description:

Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury

anakinra (150mg): intraarticular administration

Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury

Saline intraarticularly: intraarticular administration

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Other Pre-specified Outcome
Title Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Between Groups
Hide Description KOOS QOL
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was terminated due to lack of funding so an insufficient number of participants were consented to generate meaningful data.
Arm/Group Title Anakinra Placebo Control
Hide Arm/Group Description:

Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury

anakinra (150mg): intraarticular administration

Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury

Saline intraarticularly: intraarticular administration

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Placebo Control
Hide Arm/Group Description

Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury

anakinra (150mg): intraarticular administration

Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury

Saline intraarticularly: intraarticular administration

All-Cause Mortality
Arm 1 Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Hide Serious Adverse Events
Arm 1 Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Placebo Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Cale Jacobs
Organization: University of Kentucky
Phone: 859-218-3065
EMail: cale.jacobs@uky.edu
Layout table for additonal information
Responsible Party: Cale Jacobs, PhD, University of Kentucky
ClinicalTrials.gov Identifier: NCT02930122    
Other Study ID Numbers: 45595
First Submitted: October 7, 2016
First Posted: October 12, 2016
Results First Submitted: October 4, 2021
Results First Posted: October 27, 2021
Last Update Posted: November 24, 2021