Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis… (NCT01356602) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
United States397 participantsStarted 2011-05
Plain-language summary
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups