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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01356602 | Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients | PHASE3 | COMPLETED | 397 | — | — | May 1, 2011 | Sep 1, 2012 | Jan 29, 2014 | 99 | United States, Canada +3 |
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
| Arm | Type | Description |
|---|---|---|
| Canakinumab, pre-filled syringes (PFS) | EXPERIMENTAL | Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug. |
| Canakinumab, lyophilizate (LYO) | ACTIVE_COMPARATOR | The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug. |
| Triamcinolone Acetonide | ACTIVE_COMPARATOR | The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug. |
| Name | Type | Description |
|---|---|---|
| Canakinumab pre-filled syringe | DRUG | Canakinumab pre-filled syringe |
| Canakinumab lyophilized powder | DRUG | Canakinumab lyophilized powder |
| Triamcinolone Acetonide | DRUG | Triamcinolone Acetonide |
| Placebo | DRUG | Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide |
Inclusion criteria: * 3 or more gout flares within last year * Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine * Body mass index of less than or equal to 45 kg/m2 Exclusion criteria: * Use of the following therapies (within varying protocol defined timeframes): cort...