Knee Osteoarthritis
Conditions
Keywords
viscosupplement, osteoarthritis, knee, intra-articular injection, arthritis, degenerative
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.
Interventions
DRUGJTA-004 intra-articular injection
Each patient will undergo a single injection of JTA-004 into the knee joint
DEVICEReference product intra-articular injection
Each patient will undergo a single injection of Reference product into the knee joint
Sponsors
Bone Therapeutics S.A
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC® Pain Subscale at Month 3 | Baseline and 3 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 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 | Baseline and 2 weeks | 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 |
Participant flow
Pre-assignment details
From the patients enrolled in the study at Visit #1 (screening visit), 173 patients were randomized just before Visit #2 (within 6 weeks after confirmation of eligibility). During visit #2, a total of 164 patients were treated (41 subject in each treatment group) and included in the FAS. 9 randomized patients were not treated.
Participants by arm
| Arm | Count |
|---|---|
| Reference Product Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint | 41 |
| JTA-004 50 (2 ml) JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint | 41 |
| JTA-004 50 (4 ml) JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint | 41 |
| JTA-004 100 (2 ml) JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint | 41 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 | 4 |
| Overall Study | Lost to Follow-up | 1 | 3 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Reference Product | JTA-004 50 (2 ml) | JTA-004 50 (4 ml) | JTA-004 100 (2 ml) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 7.7 | 64.2 years STANDARD_DEVIATION 8 | 62.9 years STANDARD_DEVIATION 7.2 | 61.7 years STANDARD_DEVIATION 7 | 62.7 years STANDARD_DEVIATION 7.5 |
| BMI | 27.5 kg/m^2 STANDARD_DEVIATION 4.2 | 29.0 kg/m^2 STANDARD_DEVIATION 3.9 | 28.0 kg/m^2 STANDARD_DEVIATION 3.6 | 29.6 kg/m^2 STANDARD_DEVIATION 3.5 | 28.5 kg/m^2 STANDARD_DEVIATION 3.9 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment Belgium | 41 Participants | 41 Participants | 41 Participants | 41 Participants | 164 Participants |
| Sex: Female, Male Female | 30 Participants | 31 Participants | 27 Participants | 24 Participants | 112 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 14 Participants | 17 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 11 / 41 | 3 / 41 | 12 / 41 | 8 / 41 |
| serious Total, serious adverse events | 2 / 41 | 4 / 41 | 1 / 41 | 2 / 41 |
Outcome results
Primary
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.
Time frame: Baseline and 6 months
Population: The primary efficacy parameter results were evaluated on JTA-004 100 (2 mL) (the most effective strength) and reference group only.~From the 41 patients treated per group, pain subscale evaluation was not performed at 6 months for 6 patients from JTA-004 100 (2 mL) and 2 patients from Reference product group due to patient discontinuation.~Statistical analysis was performed on the Full Analysis Set (FAS) (= all randomized and treated patients).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTA-004 100 (2 mL) | Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6 | -23.6 mm | Standard Error 4.6 |
| Reference Product | Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6 | -14.1 mm | Standard Error 4.3 |
Comparison: The primary endpoint is the 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.p-value: 0.14195% CI: [-22.21, 3.23]ANCOVA
Secondary
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.
Time frame: Baseline and 3 months
Population: The secondary efficacy parameter results were evaluated on JTA-004 100 (2 mL) (the most effective strength) and reference group only.~From the 41 patients treated per group, pain subscale evaluation at 3 month was not performed for 6 patients from JTA-004 100 (2 mL) and 1 patients from Reference product group due to patient discontinuation.~Statistical analysis was performed on the Full Analysis Set (FAS) (= all randomized and treated patients).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTA-004 100 (2 mL) | WOMAC® Pain Subscale at Month 3 | -26.8 mm | Standard Deviation 3.9 |
| Reference Product | WOMAC® Pain Subscale at Month 3 | -15.1 mm | Standard Deviation 3.7 |
p-value: 0.03895% CI: [-22.6, -0.66]ANCOVA
Secondary
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.
Time frame: Baseline and 3 months
Population: The primary efficacy parameter results were evaluated on JTA-004 100 (2 mL) (the most effective strength) and reference group only. From the 41 patients treated per group, total score evaluation was not performed at month 3 for 7 patients from JTA-004 100 (2 mL) group and 1 patient from Reference group due to discontinuation of patients and deviation (at least one subscale of Total score not evaluated) Full Analysis Set (FAS) (= all randomized and treated patients)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTA-004 100 (2 mL) | WOMAC® Total Score Over Time | -22.3 mm | Standard Deviation 3.8 |
| Reference Product | WOMAC® Total Score Over Time | -19.4 mm | Standard Deviation 3.6 |
p-value: 0.97295% CI: [-16.52, 10.65]Mixed Models Analysis
Secondary
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.
Time frame: Baseline and 6 months
Population: The primary efficacy parameter results were evaluated on JTA-004 100 (2 mL) (the most effective strength) and reference group only. From the 41 patients treated per group, total score evaluation was not performed at month 6 for 6 patients from JTA-004 100 (2 mL) group and 2 patient from Reference group due to discontinuation of patients or deviation (at least one subscale of Total score not evaluated) Full Analysis Set (FAS) (= all randomized and treated patients)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTA-004 100 (2 mL) | WOMAC® Total Score Over Time | -23.7 mm | Standard Deviation 4.3 |
| Reference Product | WOMAC® Total Score Over Time | -16.5 mm | Standard Deviation 4.1 |
p-value: 0.59995% CI: [-22.28, 7.94]Mixed Models Analysis
Secondary
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
Time frame: Baseline and 2 weeks
Population: The primary efficacy parameter results were evaluated on JTA-004 100 (2 mL) (the most effective strength) and reference group only.~Full Analysis Set (FAS) = all randomized and treated patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTA-004 100 (2 mL) | WOMAC® Total Score Over Time | -21.0 mm | Standard Deviation 3.1 |
| Reference Product | WOMAC® Total Score Over Time | -19.5 mm | Standard Deviation 3.1 |
p-value: 0.99795% CI: [-12.7, 9.74]Mixed Models Analysis
Post Hoc
WOMAC® Pain Subscale Over Time From Pooled JTA-004 Treatment Groups
The primary endpoint is the Western Ontario McMaster universities (WOMAC®) VA3.1 Pain Subscale A: the individual changes in WOMAC® 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
Population: A comparison od pooled JTA-004 treated patients (all strengths) and Reference group was conducted to complete the study and evaluate the efficacy of JTA-004 product versus Reference. On the 41 patients treated per group, 2 patients from JTA 50 (2ml), 6 patients from JTA 100 (2 ml) and 1 patient from Reference were not analysed for total score due to patient discontinuation.~Full Analysis Set (FAS) (= all randomized and treated patients)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTA-004 100 (2 mL) | WOMAC® Pain Subscale Over Time From Pooled JTA-004 Treatment Groups | -27.2 mm | Standard Deviation 2.2 |
| Reference Product | WOMAC® Pain Subscale Over Time From Pooled JTA-004 Treatment Groups | -16.4 mm | Standard Deviation 3.7 |
p-value: 0.014ANCOVA
Post Hoc
WOMAC® Pain Subscale Score Over Time From Pooled JTA-004 Treatment Groups
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC Total Score between Baseline and M6 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 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 knee disease severity.
Time frame: Baseline and 6 months
Population: A comparison of pooled JTA-004 treated patients (all strengths) and Reference was conducted to evaluate the efficacy of JTA-004 product versus Reference. On the 41 patients treated per group, 5 patients from JTA 50 (2ml), 1 patient from JTA 50 (4ml), 6 patients from JTA 100 (2 ml) and 2 patients from Reference were not analysed for total score due to patient discontinuation Full Analysis Set (FAS) (= all randomized and treated patients)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTA-004 100 (2 mL) | WOMAC® Pain Subscale Score Over Time From Pooled JTA-004 Treatment Groups | -26.1 mm | Standard Deviation 2.4 |
| Reference Product | WOMAC® Pain Subscale Score Over Time From Pooled JTA-004 Treatment Groups | -15.6 mm | Standard Deviation 4.1 |
p-value: 0.03ANCOVA
Post Hoc
WOMAC® Total Score Over Time From Pooled JTA-004 Treatment Groups
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 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 and osteonecrosis symptoms. The Total score (VAS format) was determined by measuring in mm 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
Population: A post-hoc analysis was conducted comparing pooled JTA-004 treated patients (all strengths) and patients treated with Reference product to complete the study and evaluate the efficacy of JTA-004 product versus Reference.~At month 3, on the 41 patients treated per group, 3 patients from JTA 50 (2ml), 7 patients from JTA 100 (2 ml) and 1 patient from Reference were not analysed for total score due to patient discontinuation or deviation (at least one subscale not evaluated)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTA-004 100 (2 mL) | WOMAC® Total Score Over Time From Pooled JTA-004 Treatment Groups | -26.3 mm | Standard Deviation 2.2 |
| Reference Product | WOMAC® Total Score Over Time From Pooled JTA-004 Treatment Groups | -19.7 mm | Standard Deviation 3.7 |
p-value: 0.126ANCOVA
Post Hoc
WOMAC® Total Score Over Time From Pooled JTA-004 Treatment Groups
The Western Ontario McMaster universities (WOMAC®) VA3.1 Total Score was used: the individual changes in WOMAC Total 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 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 knee disease severity.
Time frame: Baseline and 6 months
Population: A comparison of pooled JTA-004 treated patients (all strengths) vs Reference group was conducted to evaluate the efficacy of JTA-004 product versus Reference. At month 6, on the 41 patients treated per group, 5 patients JTA 50(2ml), 1 patient JTA 50 (4ml), 6 patients JTA 100 (2 ml) and 2 patients from Reference were not analysed for total score due to patient discontinuation or deviation (at least one subscale not evaluated) Full Analysis Set (FAS) (= all randomized and treated patients)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTA-004 100 (2 mL) | WOMAC® Total Score Over Time From Pooled JTA-004 Treatment Groups | -26.2 mm | Standard Deviation 2.4 |
| Reference Product | WOMAC® Total Score Over Time From Pooled JTA-004 Treatment Groups | -17.3 mm | Standard Deviation 4.1 |
p-value: 0.064ANCOVA