Knee OsteoarthritisPhase 2/3NCT02740231
A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis
A Phase 2/3 study testing JTA-004 intra-articular injection and Reference product intra-articular injection in people with Knee Osteoarthritis, run by Bone Therapeutics S.A.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- JTA-004 intra-articular injection and Reference product intra-articular injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to 27 Apr 2018
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
About this study
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
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- JTA-004 intra-articular injection, Reference product intra-articular injection
- Keywords
- viscosupplement, osteoarthritis, knee, intra-articular injection, arthritis, degenerative
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTA-004 intra-articular injectionDrug
Each patient will undergo a single injection of JTA-004 into the knee joint
Reference product intra-articular injectionDevice
Each patient will undergo a single injection of Reference product into the knee joint
| Study group | Role | What they receive |
|---|---|---|
| Reference product | Active comparator | Hylan G-F 20 Receives: Device: Reference product intra-articular injection |
| JTA-004 50 (2 ml) | Experimental | Sodium hyaluronate, plasma proteins and clonidine Receives: Drug: JTA-004 intra-articular injection |
| JTA-004 50 (4 ml) | Experimental | Sodium hyaluronate, plasma proteins and clonidine Receives: Drug: JTA-004 intra-articular injection |
| JTA-004 100 (2 ml) | Experimental | Sodium hyaluronate, plasma proteins and clonidine Receives: Drug: JTA-004 intra-articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (4)
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.
Measured: Baseline and 3 months
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
Measured: Baseline and 2 weeks
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bone Therapeutics S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740231
- Sponsor's protocol ID
- JTA-KOA1
- Status last verified
- Oct 2021
- First submitted
- 13 Apr 2016
- Last updated
- 6 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34666767
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02740231
- Acronym / sponsor ID
- JTA-KOA1
- Conditions
- Knee Osteoarthritis
- Keywords
- viscosupplement, osteoarthritis, knee, intra-articular injection, arthritis, degenerative
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Bone Therapeutics S.AIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 6 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reference product | Active comparator | Device: Reference product intra-articular injectionHylan G-F 20 |
| JTA-004 50 (2 ml) | Experimental | Drug: JTA-004 intra-articular injectionSodium hyaluronate, plasma proteins and clonidine |
| JTA-004 50 (4 ml) | Experimental | Drug: JTA-004 intra-articular injectionSodium hyaluronate, plasma proteins and clonidine |
| JTA-004 100 (2 ml) | Experimental | Drug: JTA-004 intra-articular injectionSodium hyaluronate, plasma proteins and clonidine |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ambulatory
- Diagnosed with primary knee osteoarthritis, fulfilling the following American College of Rheumatology (ACR) criteria at the target knee:
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JTA-004 intra-articular injectionEach patient will undergo a single injection of JTA-004 into the knee joint | Drug | JTA-004 100 (2 ml), JTA-004 50 (2 ml), JTA-004 50 (4 ml) |
| Reference product intra-articular injectionEach patient will undergo a single injection of Reference product into the knee joint | Device | Reference product |
Primary outcome
Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6
Time frame: Baseline and 6 months
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.
4 secondary outcomes
WOMAC® Pain Subscale at Month 3
Time frame: Baseline and 3 months
WOMAC® Total Score Over Time
Time frame: Baseline and 2 weeks
WOMAC® Total Score Over Time
Time frame: Baseline and 3 months
WOMAC® Total Score Over Time
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34666767Bettonville 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.
Related trials for Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing JTA-004 intra-articular injection and Reference product intra-articular injection in people with Knee Osteoarthritis, run by Bone Therapeutics S.A.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6 (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.