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Canakinumab pre-filled syringe · 1 trial · 1 indication
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...
Canakinumab pre-filled syringe is used for the treatment of acute gouty arthritis, specifically in patients who experience frequent flares. It is an investigational therapy being developed by Novartis AG for this metabolic condition.
Canakinumab is a monoclonal antibody that targets interleukin-1 beta (IL-1β), a cytokine involved in the inflammatory response. By neutralizing IL-1β, it aims to reduce the inflammation and pain associated with acute gouty arthritis flares.
Canakinumab pre-filled syringe is developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS.
Canakinumab pre-filled syringe is in Phase 3 clinical development for acute gouty arthritis. It is an investigational drug and has not yet been approved by regulatory authorities for this indication.
Canakinumab pre-filled syringe has been studied in a Phase 3 clinical trial with the identifier NCT01356602. This trial, titled 'Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients,' was completed and enrolled 397 participants.
Canakinumab pre-filled syringe is a formulation of canakinumab, a drug that is also known by the brand name Ilaris. The pre-filled syringe is a specific delivery device for the medication, designed for subcutaneous injection.