Back to resultsA Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
JTA-004 intra-articular injection
Reference product intra-articular injection
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring viscosupplement, osteoarthritis, knee, intra-articular injection, arthritis, degenerative
Eligibility Criteria
Inclusion Criteria:
- Ambulatory
Diagnosed with primary knee osteoarthritis, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee:
- Pain ≥ 40 mm on a 0-100 mm VAS during the 3 days preceding the date of the screening visit
- Morning stiffness not exceeding 30 minutes
- Kellgren-Lawrence grade II or III
- Insufficient / failed response to analgesic and / or NSAIDs
- No physical therapy of the knee, and knee braces for the entire duration of study
- Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
Exclusion Criteria:
Current symptoms and/or signs related to the disease under study:
- Isolated symptomatic femoropatellar OA of the target knee
- History of trauma or surgery or arthroscopy at the target knee within 6 months before inclusion
- Concomitant inflammatory disease or other condition affecting the joints (e.g., rheumatoid arthritis, septic arthritis, inflammatory joint disease, metabolic bone disease, psoriasis, gout, microcrystalline arthropathies/chondrocalcinosis, Paget's disease)
- Any musculoskeletal condition (such as hip osteoarthritis, amputation, neurologic disorder) that would impede measurement of efficacy at target knee
- Target knee prosthesis planned within 12 months after the Screening Visit
Current or previous diagnoses, signs and/or symptoms:
- Uncontrolled diabetes mellitus, end-stage hepatic or renal disease
- Current (or within the last 5 years prior to entering the study) history of solid or haematological neoplasia or bone marrow transplantation (except for basal cell carcinoma and completely excised squamous cell carcinoma)
- Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or laboratory abnormalities, as judged by the Investigator
- Current or past history of coagulation disorders, as judged by the Investigator
- Hypersensitivity to any components of HA-based injection products
- History of hypersensitivity to human biological material including blood and blood derived products, potential excipients and residues from manufacturing process documented clinically or by laboratory tests
- Hypersensitivity to avian proteins
- Life expectancy less than 6 months
Current or previous treatment:
- Participation in another clinical study within 6 months prior to Screening
- Patients previously treated with JTA-004
Treatment:
- Within 6 months prior to Screening: intra-articular hyaluronic acid injection at the target knee
- Within 2 months prior to Screening: intra-articular glucocorticoids at the target knee
- Current chemo-, radio- or immuno-cancer-therapy or immunosuppressive therapy
- Current anti-hypertensive medication the effects of which are known to be potentiated by a single dose of clonidine
- Current (or within 6 months prior to Screening) illicit drug abuse
Safety aspects concerning female subjects of childbearing potential:
- Females who are pregnant, lactating or woman with childbearing potential (last menstrual bleeding less than 12 months ago) unwilling to use medically acceptable contraception, or women with childbearing potential unwilling to perform a pregnancy test before administration of study treatment.
Other exclusion criteria:
- Body Mass Index (BMI) of 35 kg/m2 or greater
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Reference product
JTA-004 50 (2 ml)
JTA-004 50 (4 ml)
JTA-004 100 (2 ml)
Arm Description
Hylan G-F 20
Sodium hyaluronate, plasma proteins and clonidine
Sodium hyaluronate, plasma proteins and clonidine
Sodium hyaluronate, plasma proteins and clonidine
Outcomes
Primary Outcome Measures
Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.
Results are expressed as "adjusted mean" based on the model used for group comparison.
WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
Secondary Outcome Measures
WOMAC® Pain Subscale at Month 3
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 3 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.
Results are expressed as "adjusted mean" based on the model used for group comparison.
WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
WOMAC® Total Score Over Time
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and 2 weeks were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group.
Results are expressed as "adjusted mean" based on the model used for group comparison.
WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity and osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of k
WOMAC® Total Score Over Time
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and Month 3 were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group.
Results are expressed as "adjusted mean" based on the model used for group comparison.
WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
WOMAC® Total Score Over Time
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and Month 6 were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group.
Results are expressed as "adjusted mean" based on the model used for group comparison.
WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms.The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02740231
Brief Title
A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis
Official Title
A Two-stage 6-month Multicentre, Randomised, Double-blind, Controlled Study on the Safety and Efficacy Intra-articular Administration of JTA-004 in Patients With Symptomatic Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
April 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bone Therapeutics S.A
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Osteoarthritis (OA) is the most common joint disease affecting millions of people around the world, for which there is unfortunately no cure. Among existing therapies, viscosupplementation, i.e., the injection of hyaluronic acid into the joint, has an established place in the symptomatic treatment of knee OA.
The present Phase IIb/III aiming to assess the safety and efficacy of JTA-004 is organized in two phases. With results obtained in the first phase the best dose of JTA-004 is determined, and the efficacy of the selected dose will then be confirmed in the second phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
viscosupplement, osteoarthritis, knee, intra-articular injection, arthritis, degenerative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reference product
Arm Type
Active Comparator
Arm Description
Hylan G-F 20
Arm Title
JTA-004 50 (2 ml)
Arm Type
Experimental
Arm Description
Sodium hyaluronate, plasma proteins and clonidine
Arm Title
JTA-004 50 (4 ml)
Arm Type
Experimental
Arm Description
Sodium hyaluronate, plasma proteins and clonidine
Arm Title
JTA-004 100 (2 ml)
Arm Type
Experimental
Arm Description
Sodium hyaluronate, plasma proteins and clonidine
Intervention Type
Drug
Intervention Name(s)
JTA-004 intra-articular injection
Intervention Description
Each patient will undergo a single injection of JTA-004 into the knee joint
Intervention Type
Device
Intervention Name(s)
Reference product intra-articular injection
Intervention Description
Each patient will undergo a single injection of Reference product into the knee joint
Primary Outcome Measure Information:
Title
Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6
Description
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 6 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.
Results are expressed as "adjusted mean" based on the model used for group comparison.
WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
WOMAC® Pain Subscale at Month 3
Description
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale (subscale A): the individual changes in WOMAC® VA3.1 Pain Subscale Score between Baseline and Month 3 were calculated and compared by analysis of covariance (ANCOVA), adjusted for baseline value, to the Reference group.
Results are expressed as "adjusted mean" based on the model used for group comparison.
WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The WOMAC® Index Pain Subscale (VAS format) was used. The VAS score was determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks (0-100 mm) for 5 questions. Results are summed and normalized on a 100 mm scale: 0 represents no knee pain and 100 extreme knee pain.
Time Frame
Baseline and 3 months
Title
WOMAC® Total Score Over Time
Description
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and 2 weeks were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group.
Results are expressed as "adjusted mean" based on the model used for group comparison.
WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity and osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of k
Time Frame
Baseline and 2 weeks
Title
WOMAC® Total Score Over Time
Description
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and Month 3 were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group.
Results are expressed as "adjusted mean" based on the model used for group comparison.
WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
Time Frame
Baseline and 3 months
Title
WOMAC® Total Score Over Time
Description
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC VA3.1 Total Score between Baseline and Month 6 were calculated and compared by Mixed-Effect Model for Repeated Measurements, adjusted for baseline value, to the Reference group.
Results are expressed as "adjusted mean" based on the model used for group comparison.
WOMAC Osteoarthritis Index is a tri-dimensional, self-administered, patient-centred health status questionnaire for knee disease severity ans osteonecrosis symptoms.The Total score (VAS format) was determined by measuring in millimetres from the left hand end of the line to the point that the patient marks (0-100 mm) for the pain (5 questions), stiffness (2 questions), and physical function (17 questions). Results are normalized on a 0-100 mm scale format. A higher score represents a higher degree of knee disease severity.
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ambulatory
Diagnosed with primary knee osteoarthritis, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee:
Pain ≥ 40 mm on a 0-100 mm VAS during the 3 days preceding the date of the screening visit
Morning stiffness not exceeding 30 minutes
Kellgren-Lawrence grade II or III
Insufficient / failed response to analgesic and / or NSAIDs
No physical therapy of the knee, and knee braces for the entire duration of study
Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
Exclusion Criteria:
Current symptoms and/or signs related to the disease under study:
Isolated symptomatic femoropatellar OA of the target knee
History of trauma or surgery or arthroscopy at the target knee within 6 months before inclusion
Concomitant inflammatory disease or other condition affecting the joints (e.g., rheumatoid arthritis, septic arthritis, inflammatory joint disease, metabolic bone disease, psoriasis, gout, microcrystalline arthropathies/chondrocalcinosis, Paget's disease)
Any musculoskeletal condition (such as hip osteoarthritis, amputation, neurologic disorder) that would impede measurement of efficacy at target knee
Target knee prosthesis planned within 12 months after the Screening Visit
Current or previous diagnoses, signs and/or symptoms:
Uncontrolled diabetes mellitus, end-stage hepatic or renal disease
Current (or within the last 5 years prior to entering the study) history of solid or haematological neoplasia or bone marrow transplantation (except for basal cell carcinoma and completely excised squamous cell carcinoma)
Other severe acute or chronic medical or psychiatric conditions or pre-dispositions or laboratory abnormalities, as judged by the Investigator
Current or past history of coagulation disorders, as judged by the Investigator
Hypersensitivity to any components of HA-based injection products
History of hypersensitivity to human biological material including blood and blood derived products, potential excipients and residues from manufacturing process documented clinically or by laboratory tests
Hypersensitivity to avian proteins
Life expectancy less than 6 months
Current or previous treatment:
Participation in another clinical study within 6 months prior to Screening
Patients previously treated with JTA-004
Treatment:
Within 6 months prior to Screening: intra-articular hyaluronic acid injection at the target knee
Within 2 months prior to Screening: intra-articular glucocorticoids at the target knee
Current chemo-, radio- or immuno-cancer-therapy or immunosuppressive therapy
Current anti-hypertensive medication the effects of which are known to be potentiated by a single dose of clonidine
Current (or within 6 months prior to Screening) illicit drug abuse
Safety aspects concerning female subjects of childbearing potential:
Females who are pregnant, lactating or woman with childbearing potential (last menstrual bleeding less than 12 months ago) unwilling to use medically acceptable contraception, or women with childbearing potential unwilling to perform a pregnancy test before administration of study treatment.
Other exclusion criteria:
Body Mass Index (BMI) of 35 kg/m2 or greater
12. IPD Sharing Statement
Citations:
PubMed Identifier
34666767
Citation
Bettonville M, Leon M, Margaux J, Urbin-Choffray D, Theunissen E, Besse-Hammer T, Fortems Y, Verlinden S, Godeaux O, Delmarcelle AS, Kaux JF. Safety and efficacy of a single intra-articular injection of a novel enhanced protein solution (JTA-004) compared to hylan G-F 20 in symptomatic knee osteoarthritis: a randomized, double-blind, controlled phase II/III study. BMC Musculoskelet Disord. 2021 Oct 19;22(1):888. doi: 10.1186/s12891-021-04750-3.
Results Reference
derived
Learn more about this trial
A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis
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