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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference product | Active Comparator | Hylan G-F 20 |
|
| JTA-004 50 (2 ml) | Experimental | Sodium hyaluronate, plasma proteins and clonidine |
|
| JTA-004 50 (4 ml) | Experimental | Sodium hyaluronate, plasma proteins and clonidine |
|
| JTA-004 100 (2 ml) | Experimental | Sodium hyaluronate, plasma proteins and clonidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JTA-004 intra-articular injection | Drug | Each patient will undergo a single injection of JTA-004 into the knee joint |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
Exclusion Criteria:
Current symptoms and/or signs related to the disease under study:
Current or previous diagnoses, signs and/or symptoms:
Current or previous treatment:
Participation in another clinical study within 6 months prior to Screening
Patients previously treated with JTA-004
Treatment:
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:
Other exclusion criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34666767 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference Product | Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint |
| FG001 | JTA-004 50 (2 ml) | JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint |
| FG002 | JTA-004 50 (4 ml) | JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint |
| FG003 | JTA-004 100 (2 ml) | JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reference Product | Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint |
| BG001 | JTA-004 50 (2 ml) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Error | mm | Baseline and 6 months |
6 months post injection
No death was reported during the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reference Product | Reference product intra-articular injection: Each patient will undergo a single injection of Reference product into the knee joint |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis acute | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Olivier Godeaux Medical Officer | Bone Therapeutics | +32 71 12 10 00 | jta.koa1@bonetherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2017 | Jun 22, 2021 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Double-blind
| Reference product intra-articular injection | Device | Each patient will undergo a single injection of Reference product into the knee joint |
|
| 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 | 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. | 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. | Baseline and 6 months |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Adverse Event |
|
JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint
| BG002 | JTA-004 50 (4 ml) | JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint |
| BG003 | JTA-004 100 (2 ml) | JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | mm | Baseline and 3 months |
|
|
|
|
| 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 | 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 | Posted | Mean | Standard Deviation | mm | Baseline and 2 weeks |
|
|
|
|
| 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. | 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) | Posted | Mean | Standard Deviation | mm | Baseline and 3 months |
|
|
|
|
| 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. | 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) | Posted | Mean | Standard Deviation | mm | Baseline and 6 months |
|
|
|
|
| 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. | 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) | Posted | Mean | Standard Deviation | mm | Baseline and 3 months |
|
|
|
|
| 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. | 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) | Posted | Mean | Standard Deviation | mm | Baseline and 6 months |
|
|
|
|
| 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. | 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) | Posted | Mean | Standard Deviation | mm | Baseline and 3 months |
|
|
|
|
| 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. | 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) | Posted | Mean | Standard Deviation | mm | Baseline and 6 months |
|
|
|
|
| 0 |
| 41 |
| 2 |
| 41 |
| 11 |
| 41 |
| EG001 | JTA-004 50 (2 ml) | JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint | 0 | 41 | 4 | 41 | 3 | 41 |
| EG002 | JTA-004 50 (4 ml) | JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint | 0 | 41 | 1 | 41 | 12 | 41 |
| EG003 | JTA-004 100 (2 ml) | JTA-004 intra-articular injection: Each patient will undergo a single injection of JTA-004 into the knee joint | 0 | 41 | 2 | 41 | 8 | 41 |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| Barett's oesophagus | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diaorrhea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hernia eventration | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rectocele | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Osteomyelitis chronic | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Plantar Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Application Site Oedema | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Conditions aggravated | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Influenza Like Illness | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Thirst | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Delayed Recovery from Anesthesia | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Blood and Creatine Phosphokinase Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Amylase Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Blood Pressure Decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Blood Triglycerides Increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Supraventricular Extrasystoles | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
|
| Joint Injection | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Osteomyelitis Acute | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Osteomyelitis Chronic | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Major Depression | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
Not provided
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| Male |
|