Back to resultsEVI-01-IT Safety Study
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EVI-01
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring highly concentrated hyaluronic acid, knee osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Eighteen (18) years old or above;
- Patient signed informed consent form;
- Patients with stable symptoms related to knee osteoarthritis for at least 3 months prior to screening;
- Failure, inadequate response or intolerance to analgesics and/or NSAIDs or low-grade opioids;
- Kellgren-Lawrence radiographic stage: II-III diagnosed in the previous 12 months;
- WOMAC average pain index score > 40 mm and < 90 (on a VAS 0-100 mm) on the knee to be treated;
- Difference ≥ 10 mm between the WOMAC average pain score of the knee to be treated and WOMAC average pain score of the contralateral knee at screening;
- Body Mass Index (BMI) inferior to 35 kg/m2 (weight/height).
Exclusion Criteria:
- Concomitant inflammatory joint disorder;
- Had received previous visco-supplementation treatment in the study knee within 6 months or intra articular corticosteroids within 3 months* prior to inclusion;
- Infection in or around the study knee;
- Relevant skin disease in the area of injection site;
- Documented presence of injury or trauma of the study knee at screening, including evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments in the study knee;
- History of allergy or intolerance to sodium hyaluronate;
- Documented presence of osteonecrosis in one or both knees;
- Inability to understand the study procedure;
- Participation in another clinical trial within 30 days prior to screening;
- Ongoing therapy with daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment. If dose < 101 mg, it must be maintained during the study;
Pregnant or breast-feeding at inclusion.
- 1 month = 30 days
Sites / Locations
- IRCCS Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EVI-01 treatment
Arm Description
EVI-01 should be injected within the synovial cavity using standard procedures for intra-articular (IA) injections by a physician skilled in performing IA injections.
Outcomes
Primary Outcome Measures
Safety and tolerability
Primary objective of this study is to assess the safety and tolerability of EVI-01 following single intraarticular administration in the knee joint, assessed with adverse events monitoring throughout the follow up duration of six months.
Secondary Outcome Measures
Change in patient-reported pain intensity
Change in patient-reported pain intensity at Days 1 to 7 compared to baseline will be assess using a 0-100 mm Visual Analogue Scale (VAS), in which 0 means ''no pain at all'' and 100 means ''the worst possible pain''.
Change in WOMAC index
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) consists of a total of 24 questions divided in 5 questions related to pain, 2 questions related to stiffness and 17 questions related to difficulties in performing activities of daily living in relation to physical function. Each question refers to a 0-100 mm Visual Analogue Scale (VAS) in which 0 means ''no pain at all'' and 100 means ''the worst possible pain''. Change in WOMAC pain, stiffness, function and total score will be assess using WOMAC index at Day 7, Day 14, Day 30, Day 90 and Day 180 compared to baseline
Patient satisfaction for the overall treatment effect
Measurements of relief satisfaction by the patient will be assess using a 7 points Likert scale at Day 180. A 7 point Likert scale offers 7 different answer options related to an agreement that would be distinct enough for the respondents (Very good, Good, Fairly good, Same as before, Fairly bad, Bad, Very bad).
Physician satisfaction for the overall treatment effect
Measurements of relief satisfaction by the physician will be assess using a 7 points Likert scale at Day 180. A 7 point Likert scale offers 7 different answer options related to an agreement that would be distinct enough for the respondents (Very good, Good, Fairly good, Same as before, Fairly bad, Bad, Very bad).
Full Information
NCT ID
NCT05422976
First Posted
June 7, 2022
Last Updated
July 20, 2023
Sponsor
Aptissen SA
Collaborators
Donawa Lifescience
1. Study Identification
Unique Protocol Identification Number
NCT05422976
Brief Title
EVI-01-IT Safety Study
Official Title
Safety and Tolerability of a Single Intra-articular Highly Concentrated Hyaluronic Acid Injection in the Treatment of Symptomatic Knee Osteoarthritis : Pilot, 6-months, Open-label, Single-arm Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aptissen SA
Collaborators
Donawa Lifescience
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Prospective, single arm, pilot study to assess the safety and tolerability of a single intra-articular injection of EVI-01 for the treatment of symptomatic knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
highly concentrated hyaluronic acid, knee osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EVI-01 treatment
Arm Type
Experimental
Arm Description
EVI-01 should be injected within the synovial cavity using standard procedures for intra-articular (IA) injections by a physician skilled in performing IA injections.
Intervention Type
Device
Intervention Name(s)
EVI-01
Intervention Description
High molecular weight Hyaluronic Acid
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Primary objective of this study is to assess the safety and tolerability of EVI-01 following single intraarticular administration in the knee joint, assessed with adverse events monitoring throughout the follow up duration of six months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in patient-reported pain intensity
Description
Change in patient-reported pain intensity at Days 1 to 7 compared to baseline will be assess using a 0-100 mm Visual Analogue Scale (VAS), in which 0 means ''no pain at all'' and 100 means ''the worst possible pain''.
Time Frame
7 days
Title
Change in WOMAC index
Description
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) consists of a total of 24 questions divided in 5 questions related to pain, 2 questions related to stiffness and 17 questions related to difficulties in performing activities of daily living in relation to physical function. Each question refers to a 0-100 mm Visual Analogue Scale (VAS) in which 0 means ''no pain at all'' and 100 means ''the worst possible pain''. Change in WOMAC pain, stiffness, function and total score will be assess using WOMAC index at Day 7, Day 14, Day 30, Day 90 and Day 180 compared to baseline
Time Frame
6 months
Title
Patient satisfaction for the overall treatment effect
Description
Measurements of relief satisfaction by the patient will be assess using a 7 points Likert scale at Day 180. A 7 point Likert scale offers 7 different answer options related to an agreement that would be distinct enough for the respondents (Very good, Good, Fairly good, Same as before, Fairly bad, Bad, Very bad).
Time Frame
6 months
Title
Physician satisfaction for the overall treatment effect
Description
Measurements of relief satisfaction by the physician will be assess using a 7 points Likert scale at Day 180. A 7 point Likert scale offers 7 different answer options related to an agreement that would be distinct enough for the respondents (Very good, Good, Fairly good, Same as before, Fairly bad, Bad, Very bad).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Eighteen (18) years old or above;
Patient signed informed consent form;
Patients with stable symptoms related to knee osteoarthritis for at least 3 months prior to screening;
Failure, inadequate response or intolerance to analgesics and/or NSAIDs or low-grade opioids;
Kellgren-Lawrence radiographic stage: II-III diagnosed in the previous 12 months;
WOMAC average pain index score > 40 mm and < 90 (on a VAS 0-100 mm) on the knee to be treated;
Difference ≥ 10 mm between the WOMAC average pain score of the knee to be treated and WOMAC average pain score of the contralateral knee at screening;
Body Mass Index (BMI) inferior to 35 kg/m2 (weight/height).
Exclusion Criteria:
Concomitant inflammatory joint disorder;
Had received previous visco-supplementation treatment in the study knee within 6 months or intra articular corticosteroids within 3 months* prior to inclusion;
Infection in or around the study knee;
Relevant skin disease in the area of injection site;
Documented presence of injury or trauma of the study knee at screening, including evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments in the study knee;
History of allergy or intolerance to sodium hyaluronate;
Documented presence of osteonecrosis in one or both knees;
Inability to understand the study procedure;
Participation in another clinical trial within 30 days prior to screening;
Ongoing therapy with daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment. If dose < 101 mg, it must be maintained during the study;
Pregnant or breast-feeding at inclusion.
1 month = 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Zaffagnini, MD
Organizational Affiliation
IRCCS Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
EVI-01-IT Safety Study
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