NCT02930122: EASI ACL

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

Terminated Phase 2 Results posted Last updated 24 November 2021

What this trial tests

Phase 2 trial testing anakinra (150mg) in Anterior Cruciate Ligament Tear in 6 participants. Terminated before completion.

Timeline

20 June 2019

Primary endpoint
16 October 2020

16 October 2020

Quick facts

Lead sponsor	Cale Jacobs, PhD
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	6
Start date	20 June 2019
Primary completion	16 October 2020
Estimated completion	16 October 2020
Sites	1 location across United States

Drugs / interventions tested

• anakinra (150mg) — full drug profile →
• Saline intraarticularly

Conditions studied

• Anterior Cruciate Ligament Tear — all drugs for Anterior Cruciate Ligament Tear →

Sponsor

Cale Jacobs, PhD — full company profile →

Who can join

Adults 14 to 40, any sex, with Anterior Cruciate Ligament Tear. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Injury to the knee during sports participation often involves partial or full detachment of the anterior cruciate ligament (abbreviated as ACL). ACL tears cause pain, swelling and inflammation. While the swelling and inflammation usually goes away in time, individuals with ACL injuries may experience pain and notice knee instability (knee slipping, etc.). Often surgery can repair or replace the ACL within the joint, allowing individuals the ability to walk or run again pain free or participate in sports. Unfortunately, osteoarthritis of the knee, which also causes pain and swelling, can occur in that same knee 10-20 years later for reasons which are not well understood.

In this research study, the investigator hopes to reduce the initial pre-operative pain. The reduction of pain will allow for earlier movement of the knee joint and preparation for surgery. The investigator is interested to see if the use of Kineret does decrease the risk of developing arthritis in individuals with ACL injuries by treating them within 28 days after their injury.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interleukin-1 receptor antagonist (IL-1Ra) is more effective in suppressing cytokine-induced catabolism in cartilage-synovium co-culture than in cartilage monoculture.
   Mehta S, Akhtar S, Porter RM, Önnerfjord P, et al · · 2019 · cited 57× · PMID 31722745 · DOI 10.1186/s13075-019-2003-y
2. Anti-Inflammatory Therapeutic Approaches to Prevent or Delay Post-Traumatic Osteoarthritis (PTOA) of the Knee Joint with a Focus on Sustained Delivery Approaches.
   Khella CM, Horvath JM, Asgarian R, Rolauffs B, et al · · 2021 · cited 36× · PMID 34360771 · DOI 10.3390/ijms22158005
3. AMPA/kainate glutamate receptor antagonists prevent posttraumatic osteoarthritis.
   Bonnet CS, Gilbert SJ, Blain EJ, Williams AS, et al · · 2020 · cited 13× · PMID 32544091 · DOI 10.1172/jci.insight.134055
4. MOntelukast as a potential CHondroprotective treatment following Anterior cruciate ligament reconstruction (MOCHA Trial): study protocol for a double-blind, randomized, placebo-controlled clinical trial.
   Jacobs CA, Conley CEW, Kraus VB, Lansdown DA, et al · · 2022 · cited 4× · PMID 35101085 · DOI 10.1186/s13063-021-05982-3