Trial Outcomes & Findings for A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis (NCT NCT02740231)
NCT ID: NCT02740231
Last Updated: 2021-12-06
Results Overview
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.
COMPLETED
PHASE2/PHASE3
173 participants
Baseline and 6 months
2021-12-06
Participant Flow
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.
Participant milestones
| Measure |
Reference Product
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
JTA-004 50 (2 ml)
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
JTA-004 50 (4 ml)
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
JTA-004 100 (2 ml)
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
41
|
41
|
|
Overall Study
COMPLETED
|
39
|
35
|
40
|
33
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
1
|
8
|
Reasons for withdrawal
| Measure |
Reference Product
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
JTA-004 50 (2 ml)
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
JTA-004 50 (4 ml)
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
JTA-004 100 (2 ml)
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Reference Product
n=41 Participants
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
JTA-004 50 (2 ml)
n=41 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
JTA-004 50 (4 ml)
n=41 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
JTA-004 100 (2 ml)
n=41 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 7.7 • n=41 Participants
|
64.2 years
STANDARD_DEVIATION 8.0 • n=41 Participants
|
62.9 years
STANDARD_DEVIATION 7.2 • n=41 Participants
|
61.7 years
STANDARD_DEVIATION 7.0 • n=41 Participants
|
62.7 years
STANDARD_DEVIATION 7.5 • n=164 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=41 Participants
|
31 Participants
n=41 Participants
|
27 Participants
n=41 Participants
|
24 Participants
n=41 Participants
|
112 Participants
n=164 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=41 Participants
|
10 Participants
n=41 Participants
|
14 Participants
n=41 Participants
|
17 Participants
n=41 Participants
|
52 Participants
n=164 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
41 Participants
n=41 Participants
|
41 Participants
n=41 Participants
|
41 Participants
n=41 Participants
|
41 Participants
n=41 Participants
|
164 Participants
n=164 Participants
|
|
BMI
|
27.5 kg/m^2
STANDARD_DEVIATION 4.2 • n=41 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 3.9 • n=41 Participants
|
28.0 kg/m^2
STANDARD_DEVIATION 3.6 • n=41 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 3.5 • n=41 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 3.9 • n=164 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: 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).
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.
Outcome measures
| Measure |
JTA-004 100 (2 mL)
n=35 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
Reference Product
n=39 Participants
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
|---|---|---|
|
Change From Baseline in WOMAC VA3.1 Pain Subscale Score at Month 6
|
-23.6 mm
Standard Error 4.6
|
-14.1 mm
Standard Error 4.3
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: 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).
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.
Outcome measures
| Measure |
JTA-004 100 (2 mL)
n=35 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
Reference Product
n=40 Participants
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
|---|---|---|
|
WOMAC® Pain Subscale at Month 3
|
-26.8 mm
Standard Deviation 3.9
|
-15.1 mm
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: 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
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
Outcome measures
| Measure |
JTA-004 100 (2 mL)
n=41 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
Reference Product
n=41 Participants
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
|---|---|---|
|
WOMAC® Total Score Over Time
|
-21.0 mm
Standard Deviation 3.1
|
-19.5 mm
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: 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)
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.
Outcome measures
| Measure |
JTA-004 100 (2 mL)
n=34 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
Reference Product
n=40 Participants
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
|---|---|---|
|
WOMAC® Total Score Over Time
|
-22.3 mm
Standard Deviation 3.8
|
-19.4 mm
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: 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)
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.
Outcome measures
| Measure |
JTA-004 100 (2 mL)
n=35 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
Reference Product
n=39 Participants
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
|---|---|---|
|
WOMAC® Total Score Over Time
|
-23.7 mm
Standard Deviation 4.3
|
-16.5 mm
Standard Deviation 4.1
|
POST_HOC outcome
Timeframe: Baseline and 3 monthsPopulation: 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)
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.
Outcome measures
| Measure |
JTA-004 100 (2 mL)
n=113 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
Reference Product
n=40 Participants
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
|---|---|---|
|
WOMAC® Total Score Over Time From Pooled JTA-004 Treatment Groups
|
-26.3 mm
Standard Deviation 2.2
|
-19.7 mm
Standard Deviation 3.7
|
POST_HOC outcome
Timeframe: Baseline and 6 monthsPopulation: 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)
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.
Outcome measures
| Measure |
JTA-004 100 (2 mL)
n=111 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
Reference Product
n=39 Participants
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
|---|---|---|
|
WOMAC® Total Score Over Time From Pooled JTA-004 Treatment Groups
|
-26.2 mm
Standard Deviation 2.4
|
-17.3 mm
Standard Deviation 4.1
|
POST_HOC outcome
Timeframe: Baseline and 3 monthsPopulation: 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)
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.
Outcome measures
| Measure |
JTA-004 100 (2 mL)
n=115 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
Reference Product
n=40 Participants
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
|---|---|---|
|
WOMAC® Pain Subscale Over Time From Pooled JTA-004 Treatment Groups
|
-27.2 mm
Standard Deviation 2.2
|
-16.4 mm
Standard Deviation 3.7
|
POST_HOC outcome
Timeframe: Baseline and 6 monthsPopulation: 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)
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.
Outcome measures
| Measure |
JTA-004 100 (2 mL)
n=111 Participants
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
Reference Product
n=39 Participants
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
|---|---|---|
|
WOMAC® Pain Subscale Score Over Time From Pooled JTA-004 Treatment Groups
|
-26.1 mm
Standard Deviation 2.4
|
-15.6 mm
Standard Deviation 4.1
|
Adverse Events
Reference Product
JTA-004 50 (2 ml)
JTA-004 50 (4 ml)
JTA-004 100 (2 ml)
Serious adverse events
| Measure |
Reference Product
n=41 participants at risk
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
JTA-004 50 (2 ml)
n=41 participants at risk
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
JTA-004 50 (4 ml)
n=41 participants at risk
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
JTA-004 100 (2 ml)
n=41 participants at risk
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
Gastrointestinal disorders
Barett's oesophagus
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Gastrointestinal disorders
Diaorrhea
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Gastrointestinal disorders
Hernia eventration
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 2 • 6 months post injection
No death was reported during the study
|
|
Infections and infestations
Pneumonia
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
Other adverse events
| Measure |
Reference Product
n=41 participants at risk
Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint
|
JTA-004 50 (2 ml)
n=41 participants at risk
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
JTA-004 50 (4 ml)
n=41 participants at risk
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
JTA-004 100 (2 ml)
n=41 participants at risk
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
3/41 • Number of events 4 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Musculoskeletal and connective tissue disorders
Plantar Fasciitis
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
General disorders
Injection Site Pain
|
4.9%
2/41 • Number of events 2 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
General disorders
Fatigue
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
General disorders
Application Site Oedema
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
General disorders
Conditions aggravated
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
General disorders
Influenza Like Illness
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
General disorders
Thirst
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
7.3%
3/41 • Number of events 3 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Injury, poisoning and procedural complications
Delayed Recovery from Anesthesia
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Investigations
Blood and Creatine Phosphokinase Increased
|
4.9%
2/41 • Number of events 2 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Investigations
Amylase Increased
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Investigations
Blood Pressure Decreased
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
Investigations
Blood Triglycerides Increased
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
Gastrointestinal disorders
Melaena
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
Surgical and medical procedures
Joint Injection
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Infections and infestations
Osteomyelitis Acute
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
|
Infections and infestations
Osteomyelitis Chronic
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 2 • 6 months post injection
No death was reported during the study
|
|
Nervous system disorders
Headache
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Psychiatric disorders
Major Depression
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
|
Vascular disorders
Hypotension
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
2.4%
1/41 • Number of events 1 • 6 months post injection
No death was reported during the study
|
0.00%
0/41 • 6 months post injection
No death was reported during the study
|
Additional Information
Dr Olivier Godeaux Medical Officer
Bone Therapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place