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Interleukin-1 Inhibitor

Biologic Therapy for Osteoarthritis Prevention After ACL Injury

Q: Are there any current opportunities for patient enrollment in this experiment?

As per clinicaltrials.gov, this trial is presently looking for participants; the listing was first published on September 15th 2021 and has been edited as recently as June 18th 2022.

Q: For what conditions is Two doses Anakinra commonly prescribed?

Two dosages of Anakinra are frequently implemented as a treatment for Systemic Juvenile Idiopathic <a href="https://www.withpower.com/clinical-trials/arthritis">Arthritis</a> (<a href="https://www.withpower.com/clinical-trials/sjia">sjia</a>). They can also be employed to address Neonatal-Onset Multisystem Inflammatory Disease (NOMID), Interleukin Receptors, and steroids.

Q: What earlier clinical trials have been concluded regarding the efficacy of Two doses Anakinra?

Currently, 33 separate clinical trials for Two doses Anakinra are being conducted. Of these, 7 have reached their third stage of advancement. Although most investigations of this medication take place in Paris and Ile-De-France, a total 441 locations are running studies on the treatment's efficacy.

Q: Am I eligible to get involved in this investigation?

This clinical trial is open to 32 individuals aged 18-35 who have sustained an anterior cruciate ligament (ACL) tear. Candidates must possess closed growth plates as depicted by radiographs, participate in sports with cutting and pivoting motions, and not present any signs of posterior cruciate ligament injury or grade 1 medial collateral ligament damage. Additionally, ACL reconstruction surgery via bone-patellar tendon-bone autograft needs to be performed within 45 days of the initial injury. The recruited group will consist of 16 men and 16 women per treatment arm.

Q: What is the threshold of applicants for this research endeavor?

Correct. The clinicaltrials.gov platform shows that this trial, first posted on September 15th 2021, is currently looking for enrolment from 32 participants at 1 location.

Q: Is this trial accessible to individuals of greater than 50 years in age?

In order to be considered for this research, individuals must meet the age qualifications of being at least 18 and no more than 35 years old.

Phase < 1

Recruiting

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

no more than grade 1 medial collateral ligament injury

patients age 18 to 35 years with closed growth plates as visualized on plain radiographs who participate in cutting and pivoting activities.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surveys will be obtained prior to surgery and then at 3, 6, 9, 12 and 24 months following surgery

Awards & highlights

Study Summary

This trial is testing whether or not a common injury, an ACL tear, can be prevented from turning into arthritis by using a naturally occurring protein.

Who is the study for?

This trial is for men and women aged 18-35 with a recent ACL injury who plan to have ACL reconstruction surgery within 45 days. They must not have severe knee injuries besides the ACL, no history of certain diseases or conditions, and no prior treatments that could interfere with the study.Check my eligibility

What is being tested?

The trial tests if injecting Anakinra (a biologic therapy) into the knee after an ACL injury can prevent osteoarthritis. Participants are randomly placed in two groups: one gets Anakinra injections, while the other receives placebo saline injections before their surgery.See study design

What are the potential side effects?

Anakinra may cause reactions at the injection site, increased risk of infection due to immune system suppression, headaches, nausea, and potential allergic reactions in those sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My knee injury is minor.

Select...

I am between 18 and 35 years old and engage in sports that involve sudden direction changes.

Select...

My ACL injury was confirmed by an MRI less than 2 weeks ago.

Select...

I do not have an injury to the outer back part of my same-side knee.

Select...

My knee's back ligament is not injured, according to tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surveys will be obtained prior to surgery and then at 3, 6, 9, 12 and 24 months following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~surveys will be obtained prior to surgery and then at 3, 6, 9, 12 and 24 months following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and surveys will be obtained prior to surgery and then at 3, 6, 9, 12 and 24 months following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cartilage biomarker analysis of synovial fluid

Cytokine level analysis of synovial fluid

Secondary outcome measures

Cartilage biomarker analysis of urine

Patient-reported knee pain and function

Other outcome measures

MRI

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Two doses AnakinraActive Control1 Intervention

Subjects will receive two injections of anakinra after ACL injury, prior to surgery

Group II: ControlPlacebo Group1 Intervention

Subjects will receive two injections of sterile saline after ACL injury, prior to surgery

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,530 Previous Clinical Trials

10,278,170 Total Patients Enrolled

Orthopedic Research and Education FoundationOTHER

19 Previous Clinical Trials

11,368 Total Patients Enrolled

Media Library

Anakinra (Interleukin-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03968913 — Phase < 1

Anterior Cruciate Ligament Injury Research Study Groups: Control, Two doses Anakinra

Anterior Cruciate Ligament Injury Clinical Trial 2023: Anakinra Highlights & Side Effects. Trial Name: NCT03968913 — Phase < 1

Anakinra (Interleukin-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03968913 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities for patient enrollment in this experiment?

"As per clinicaltrials.gov, this trial is presently looking for participants; the listing was first published on September 15th 2021 and has been edited as recently as June 18th 2022."

Answered by AI

For what conditions is Two doses Anakinra commonly prescribed?

"Two dosages of Anakinra are frequently implemented as a treatment for Systemic Juvenile Idiopathic Arthritis (sjia). They can also be employed to address Neonatal-Onset Multisystem Inflammatory Disease (NOMID), Interleukin Receptors, and steroids."

Answered by AI

What earlier clinical trials have been concluded regarding the efficacy of Two doses Anakinra?

"Currently, 33 separate clinical trials for Two doses Anakinra are being conducted. Of these, 7 have reached their third stage of advancement. Although most investigations of this medication take place in Paris and Ile-De-France, a total 441 locations are running studies on the treatment's efficacy."

Answered by AI

Am I eligible to get involved in this investigation?

"This clinical trial is open to 32 individuals aged 18-35 who have sustained an anterior cruciate ligament (ACL) tear. Candidates must possess closed growth plates as depicted by radiographs, participate in sports with cutting and pivoting motions, and not present any signs of posterior cruciate ligament injury or grade 1 medial collateral ligament damage. Additionally, ACL reconstruction surgery via bone-patellar tendon-bone autograft needs to be performed within 45 days of the initial injury. The recruited group will consist of 16 men and 16 women per treatment arm."

Answered by AI

What is the threshold of applicants for this research endeavor?

"Correct. The clinicaltrials.gov platform shows that this trial, first posted on September 15th 2021, is currently looking for enrolment from 32 participants at 1 location."

Answered by AI