This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
6
10 mg/kg intravenous infusion 250 mL over 2 hours.
12 mg intravenous infusion 50 mL over 30 minutes.
5% glucose in water intravenous infusion.
Novartis Investigator Site
Birmingham, Alabama, United States
Novartis Investigator Site
New Brunswick, New Jersey, United States
Novartis Investigator Site
Lausanne, Switzerland
Novartis Investigator Site
Glasgow, United Kingdom
Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale
72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.
Time frame: 72 hours
Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period
Time frame: 72 hours
Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period
Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.
Time frame: 4 months
Time to Walk Independently (if Applicable) During Treatment Period
Time frame: 4 months
Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study
Additional safety information can be found in the Adverse Event section.
Time frame: 4 months
Change in C-reactive Protein (CRP) From Baseline at Month 4
Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.
Time frame: Baseline, Month 4
Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4
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Placebo intravenous infusion.
Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.
Time frame: Baseline, Month 4
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period
Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).
Time frame: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119
Change From Baseline in Pain Using a Visual Analog Scale at Month 4
Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.
Time frame: Baseline, Month 4
Number of Patients Who Took Rescue Medication
Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.
Time frame: 4 months