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

NCT02930122 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 45595
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (1)

• Change of Knee Injury and Osteoarthritis Outcome Score (KOOS) Symptom Score Between Groups

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

  1 year

Secondary Outcomes (1)

• Change in CTX-II Levels From Injury to Time of Surgery

  time of surgery

Other Outcomes (2)

• MRI T1rho Changes

  1 year

• Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Score Between Groups

  1 year

Study Arms (2)

Anakinra

EXPERIMENTAL

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

Drug: anakinra (150mg)

Placebo Control

PLACEBO COMPARATOR

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

Other: Saline intraarticularly

Interventions

anakinra (150mg) DRUG

intraarticular administration

Also known as: Kineret

Anakinra

Saline intraarticularly OTHER

intraarticular administration

Also known as: Saline (0.9%)

Placebo Control

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Acute ACL Tear and Painful Effusions
• Signed and dated combined informed consent/HIPAA form and if a minor, a signed assent.
• Willingness to comply with all study procedures and availability for the duration of the study
• For females of reproductive potential: use of highly effective contraception.
• Currently participating in a sporting activity
• Documentation of closed growth plates as noted on the screening x-ray

You may not qualify if:

• underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis etc)
• have been diagnosed with hepatitis B or tuberculosis
• currently have an infections, including infection of the skin, or have signs and symptoms of an infection, including fever.
• any abnormalities in their white blood cell counts
• have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs
• other major medical condition requiring treatment with immunosuppressant or modulating drugs.
• A history of chronic use of non-steroidal anti-inflammatory drugs
• Currently taking immunosuppressant medication, including oral and parenteral corticosteroids (topical and stable dose inhaled corticosteriods are acceptable)
• Females who are pregnant or breastfeeding
• Received a "live" vaccine (smallpox, MMR (measles, mumps and rubella), flu, polio, typhoid, chicken pox, yellow fever, herpes zoster) 4 weeks prior to screening.
• A history of bleeding disorders or are taking any blood thinning medications, aspirin or other medications affecting blood clotting.
• Previous exposure or allergic reaction to anakinra
• Allergy to latex or tape
• Allergy to Kineret or have had a reaction to any local or general anesthesia
• prior knee surgery (contralateral)

Sponsors & Collaborators

• Cale Jacobs, PhD: lead

Study Sites (1)

UK Healthcare at Turfland

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Interleukin 1 Receptor Antagonist Protein; Sodium Chloride

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Cale Jacobs
• Organization: University of Kentucky

cale.jacobs@uky.edu

859-218-3065

Study Officials

• Austin Stone, MD

  University of Kentucky

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Research

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 12, 2016
• Study Start: June 20, 2019
• Primary Completion: October 16, 2020
• Study Completion: October 16, 2020
• Last Updated: November 24, 2021
• Results First Posted: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)