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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04333160 | Phase III Study on the Safety and Efficacy of a Single Intra-articular Administration of JTA-004 in Symptomatic Knee Osteoarthritis | PHASE3 | COMPLETED | 746 | — | — | Mar 10, 2020 | Dec 9, 2021 | Mar 2, 2022 | 22 | Belgium, Czechia +5 |
Difference between JTA-004 and placebo in mean change from baseline in knee pain at Month 3 using the Western Ontario McMaster University (WOMAC®) Visual Analogue 3.1 pain subscale (subscale A; score 0 (no-pain)-100 (worst imaginable pain) mm).
| Arm | Type | Description |
|---|---|---|
| JTA-004 | EXPERIMENTAL | single knee intra-articular injection of JTA-004 solution (2ml) |
| placebo | PLACEBO_COMPARATOR | single knee intra-articular injection of saline solution (2ml) |
| Hylan G-F 20 | ACTIVE_COMPARATOR | single knee intra-articular injection of Hylan G-F 20 (6ml) |
| Name | Type | Description |
|---|---|---|
| JTA-004 | DRUG | Patients will undergo a single intra-articular injection of JTA-004 into the knee joint |
| Hylan G-F 20 | DEVICE | Patients will undergo a single intra-articular injection of Hylan G-F 20 into the knee joint |
| placebo | OTHER | Patients will undergo a single intra-articular injection of placebo into the knee joint |
Inclusion Criteria: * Ambulatory (able to walk unassisted, the use of a crutch or a walking stick (only one) is allowed if already used at screening but should be avoided during the study up to the 6-month follow-up visit) * Diagnosed with primary knee OA, fulfilling the following American College ...