- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02790723
Safety of Intra-Articular Sc-rAAV2.5IL-1Ra in Subjects With Moderate Knee OA (AAVIL-1Ra)
April 14, 2022 updated by: Christopher H. Evans, Ph.D., Mayo Clinic
A Phase I Study Evaluating the Safety of Intra-Articular Sc-rAAV2.5IL-1Ra in Subjects With Moderate Osteoarthritis of the Knee
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Age 18-80 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 3 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
- Orthopedic hardware or implantable devices in the index knee
- 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.
- 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.
- Any illness or condition which, in the investigators' judgement will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Low Dose Group
Subjects will receive a single intra-articular 2mL injection consisting of 10{11} viral genomes.
|
Self-complementing, recombinant AAV carrying IL-1Ra cDNA produced by the Research Institute at Nationwide Children's Hospital.
Other Names:
|
EXPERIMENTAL: Medium Dose Group
Subjects will receive a single intra-articular 2mL injection consisting of 10{12} viral genomes.
|
Self-complementing, recombinant AAV carrying IL-1Ra cDNA produced by the Research Institute at Nationwide Children's Hospital.
Other Names:
|
EXPERIMENTAL: High Dose Group
Subjects will receive a single intra-articular 2mL injection consisting of 10{13} viral genomes.
|
Self-complementing, recombinant AAV carrying IL-1Ra cDNA produced by the Research Institute at Nationwide Children's Hospital.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
53 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher H. Evans, Ph.D., Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 2022 AMSSM Rising With Research Presentations. Clin J Sport Med. 2022 Mar 1;32(2):168-176. doi: 10.1097/JSM.0000000000001014. No abstract available.
- 2021 AMSSM Oral Research Poster Presentations. Clin J Sport Med. 2021 Mar 1;31(2):185-221. doi: 10.1097/JSM.0000000000000914. No abstract available.
- Mehta S, He T, Bajpayee AG. Recent advances in targeted drug delivery for treatment of osteoarthritis. Curr Opin Rheumatol. 2021 Jan;33(1):94-109. doi: 10.1097/BOR.0000000000000761.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 5, 2019
Primary Completion (ACTUAL)
March 17, 2022
Study Completion (ACTUAL)
March 17, 2022
Study Registration Dates
First Submitted
May 3, 2016
First Submitted That Met QC Criteria
May 31, 2016
First Posted (ESTIMATE)
June 6, 2016
Study Record Updates
Last Update Posted (ACTUAL)
April 15, 2022
Last Update Submitted That Met QC Criteria
April 14, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-007542
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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