Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02740231 | A Study on Visco-antalgic Intra-articular Administration in Symptomatic Knee Osteoarthritis | PHASE2 | COMPLETED | 173 | — | — | Feb 1, 2016 | Apr 27, 2018 | Dec 6, 2021 | - | — |
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| JTA-004 intra-articular injection | DRUG | Each patient will undergo a single injection of JTA-004 into the knee joint |
| Reference product intra-articular injection | DEVICE | Each patient will undergo a single injection of Reference product into the knee joint |
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 excee...