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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01431638 | Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients | PHASE3 | COMPLETED | 397 | — | — | Aug 25, 2011 | May 9, 2013 | Jul 19, 2021 | 68 | United States, Canada +2 |
| Arm | Type | Description |
|---|---|---|
| Canakinumab 150mg | EXPERIMENTAL | Canakinumab 150mg in prefilled syringe subcutaneously |
| Name | Type | Description |
|---|---|---|
| Canakinumab 150mg in prefilled syringe | DRUG | Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares |
Inclusion criteria: * Compliance and completion of the canakinumab PFS core study * Unchanged significant clinical medical history from entry into core study Exclusion criteria: * Physician judgment of unsuitability for the study * Pregnant or nursing women Other protocol-defined inclusion/exclus...