Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Acute Gouty Arthritis
About this trial
This is an interventional treatment trial for Acute Gouty Arthritis focused on measuring Gout, arthritis, gout flare, acute gout, gouty, rheumatic disease, uric acid
Eligibility Criteria
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): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine.
- Hemodialysis
- Live vaccine within 3 months before first dose
- Donation or loss of 400 mL or more within 3 months before first dose
- Gout brought on by other factors such as chemotherapy, lead, transplant, etc.
- Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis
- Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions
- Significant cardiovascular conditions such as uncontrolled hypertension
- Significant medical diseases such as uncontrolled diabetes, thyroid disease
- History of malignancy of any organ system within the past 5 years
- Women who are pregnant or nursing
- Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Canakinumab, pre-filled syringes (PFS)
Canakinumab, lyophilizate (LYO)
Triamcinolone Acetonide
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.
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.
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.