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

• Status: Terminated
• Trial end date: 2020-10-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cale Jacobs, PhD; Christian Lattermann
• Collaborator: Arthritis Foundation
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• have received any investigational drug with 4 weeks of study Visit 1