Trial Outcomes & Findings for IL-1RA Treatment in Patients With Acute ACL Tear and Painful Effusions (NCT NCT02930122)

NCT ID: NCT02930122

Last Updated: 2021-11-24

Results Overview

KOOS symptoms scores range from 0 to 100, with higher scores indicating less severe symptoms.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

1 year

Results posted on

2021-11-24

Participant Flow

An insufficient number of participants were consented to generate meaningful data for this study as the study was terminated due to lack of funding.

Participant milestones

Participant milestones
Measure	Anakinra Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury anakinra (150mg): intraarticular administration	Placebo Control Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury Saline intraarticularly: intraarticular administration
Overall Study STARTED	3	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Anakinra Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury anakinra (150mg): intraarticular administration	Placebo Control Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury Saline intraarticularly: intraarticular administration
Overall Study The trial was terminated prior to participating completing the study due to lack of funding.	3	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=3 Participants Intervention: anakinra (150mg) Participants will receive an intraarticular injection of anakinra (150mg) at 0-28 days post injury anakinra (150mg): intraarticular administration	Placebo Control n=3 Participants Intervention: Saline (0.9%) Participants will receive a saline placebo injection within 28 days of injury Saline intraarticularly: intraarticular administration	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	16 years n=99 Participants	18 years n=107 Participants	17 years n=206 Participants
Sex: Female, Male Female	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Sex: Female, Male Male	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	3 participants n=99 Participants	3 participants n=107 Participants	6 participants n=206 Participants
Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptom Score	14 units on a scale n=99 Participants	15 units on a scale n=107 Participants	14.5 units on a scale n=206 Participants

PRIMARY outcome

Timeframe: 1 year

Population: The trial was terminated due to lack of funding so an insufficient number of participants were consented to generate meaningful data.

KOOS symptoms scores range from 0 to 100, with higher scores indicating less severe symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: time of surgery

Population: The trial was terminated due to lack of funding so an insufficient number of participants were consented to generate meaningful data.

CTX-II levels measured by ELISA

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: The trial was terminated due to lack of funding so an insufficient number of participants were consented to generate meaningful data.

MRI: T1rho values in Medial and lateral femoral condyle as well as medial and lateral tibial plateau

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: The trial was terminated due to lack of funding so an insufficient number of participants were consented to generate meaningful data.

KOOS QOL

Outcome measures

Outcome data not reported

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cale Jacobs

University of Kentucky

Phone: 859-218-3065

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place