Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
- Conditions
- Arthritis, Gouty
- Interventions
- Biological: canakinumabOther: placebo matching dexamethasoneOther: placebo matching canakinumab
- Registration Number
- NCT00663169
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- score over 50 on the 0-100 VAS pain scale
- acute, confirmed gout flare for no longer than 3 days
- Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
- Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
- Pregnant or breastfeeding women
- Major surgery with high infection risk
- History of severe allergy to food or drugs
- History or risk of tuberculosis
- Active infection
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Canakinumab canakinumab Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. Canakinumab placebo matching dexamethasone Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1. Dexamethasone dexamethasone Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1. Dexamethasone placebo matching canakinumab Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale 72 hours 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.
- Secondary Outcome Measures
Name Time Method Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period 72 hours Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period 4 months Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.
Time to Walk Independently (if Applicable) During Treatment Period 4 months Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study 4 months Additional safety information can be found in the Adverse Event section.
Change in C-reactive Protein (CRP) From Baseline at Month 4 Baseline, 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.
Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4 Baseline, Month 4 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.
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119 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).
Change From Baseline in Pain Using a Visual Analog Scale at Month 4 Baseline, 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.
Number of Patients Who Took Rescue Medication 4 months 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.
Trial Locations
- Locations (1)
Novartis Investigator Site
🇬🇧Glasgow, United Kingdom