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Trial record 1 of 2 for:    Osteoarthritis, Knee IL1ra
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Safety of Intra-Articular Sc-rAAV2.5IL-1Ra in Subjects With Moderate Knee OA (AAVIL-1Ra)

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ClinicalTrials.gov Identifier: NCT02790723
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Christopher H. Evans, Ph.D., Mayo Clinic

Study Description
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Brief Summary:
This study seeks to determine the safety of three different doses of sc-rAAV2.5IL-1Ra delivered by intra-articular injection into one knee joint of patients with moderate OA of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: sc-rAAV2.5IL-1Ra Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Evaluating the Safety of Intra-Articular Sc-rAAV2.5IL-1Ra in Subjects With Moderate Osteoarthritis of the Knee
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Anakinra

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Dose Group
Subjects will receive a single intra-articular 10mL injection consisting of 10{11} viral genomes.
 Drug: sc-rAAV2.5IL-1Ra
Self-complementing, recombinant AAV carrying IL-1Ra cDNA produced by the Research Institute at Nationwide Children's Hospital.
Other Names:
  • AAVIL-1Ra
  • IL-1Ra
Experimental: Medium Dose Group
Subjects will receive a single intra-articular 10mL injection consisting of 10{12} viral genomes.
 Drug: sc-rAAV2.5IL-1Ra
Self-complementing, recombinant AAV carrying IL-1Ra cDNA produced by the Research Institute at Nationwide Children's Hospital.
Other Names:
  • AAVIL-1Ra
  • IL-1Ra
Experimental: High Dose Group
Subjects will receive a single intra-articular 10mL injection consisting of 10{13} viral genomes.
 Drug: sc-rAAV2.5IL-1Ra
Self-complementing, recombinant AAV carrying IL-1Ra cDNA produced by the Research Institute at Nationwide Children's Hospital.
Other Names:
  • AAVIL-1Ra
  • IL-1Ra


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects experiencing severe adverse events. [ Time Frame: 53 weeks ]
    Assess the local and systemic safety of three different doses of sc-rAAV2.5IL-1Ra delivered by intra-articular injection into one knee joint of patients with moderate OA of the knee.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • Gender: both males and females
  • Target disease: Moderate OA of the knee
  • Persistent symptoms, despite standard NSAID
  • Absence of clinically significant abnormal values for the following:
  • Complete blood count
  • Prothrombin Time, Activated partial thromboplastin time
  • Blood chemistry (Glucose, Na, K, Cl, CO2, BUN, creatinine, Ca, PO4, magnesium, uric acid)
  • Liver function tests (amylase, total bilirubin, alkaline phosphate, GGT, AST, ALT, total protein, albumin)
  • Able and willing to return to the Mayo Clinic for follow-up visits, as required by this study
  • Able undergo MRI of the knee
  • Subjects should be able to give appropriate consent.
  • Potential subjects should have failed a three-month trial of a minimum of two conservative therapies before being considered for this trial. These conservative therapies include: activity modification, weight loss, physical therapy, and anti-inflammatory or injection therapy.

Exclusion Criteria:

  • Pregnant, or currently breast-feeding
  • Ongoing infectious disease including HIV, HTLV, hepatitis, syphilis or tuberculosis positive
  • Individuals who have OA as part of another syndrome (e.g. Ehler's Danlos, Stickler syndrome, etc.)
  • Systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis.
  • Clinically significant cardiovascular, renal, hepatic, endocrine disease, diabetes, cancer, autoimmune diseases; a serious infection or major operation within 30 days of enrollment; a history of untreated psychiatric disease or recent history of alcoholism or drug addiction.
  • Currently taking immunosuppressant medications
  • Anticipated major surgery during the study period.
  • Individuals involved in another interventional protocol, or have been treated under one within the last 3 months.
  • Intra-articular therapy in the index knee within the previous 6 months.
  • Surgery to the target knee within 6 months prior to screening.
  • Surgery to other weight bearing joints if it will interfere with knee assessments
  • Prior articular transplant procedures
  • Prior reconstruction surgery to the target knee within 12 months
  • X-ray findings of acute fractures
  • Known severe loss of bone density, and/or severe bone or joint deformity in the target knee.
  • Knee pain associated with patella-femoral arthritis or chondromalacia in the target knee.
  • Significant target knee infection or overlying skin disorder/infection within the previous 6 months prior to study enrollment
  • Require cane or other assistive device for walking
  • Symptomatic OA of the hips, spine or ankle if it would interfere with the evaluation of the target knee,
  • History of documented nerve damage in the affected limb, or vascular insufficiency,
  • Condition requiring use of systemic steroids,
  • Coagulation disorder.
  • Patients with unstable knees
  • Temperature above 99.5o F.
  • Identification as a member of a vulnerable population.
  • BMI greater than 40.
  • History of allergy to local anesthetics
  • Currently taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within the 3 months prior to entry in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790723


Contacts
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Contact: Tyson L. Scrabeck (507)538-1016 scrabeck.tyson@mayo.edu
Contact: Zachary W. Pohlkamp (507)293-7466 pohlkamp.zachary@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tyson L. Scrabeck    507-538-1016    scrabeck.tyson@mayo.edu   
Contact: Zachary W. Pohlkamp    (507)293-7466    pohlkamp.zachary@mayo.edu   
Principal Investigator: Jay Smith, M.D.         
Sub-Investigator: Matthew A. Frick, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Christopher H. Evans, Ph.D. Mayo Clinic
More Information
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Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

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Responsible Party: Christopher H. Evans, Ph.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02790723     History of Changes
Other Study ID Numbers: 15-007542
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents