Back to resultsEfficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
Primary Purpose
Arthritis, Gouty
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
canakinumab
dexamethasone
placebo matching canakinumab
placebo matching dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Gouty focused on measuring Arthritis Gouty, ACZ885, IL1B protein, Pain
Eligibility Criteria
Inclusion Criteria:
- score over 50 on the 0-100 VAS pain scale
- acute, confirmed gout flare for no longer than 3 days
Exclusion Criteria:
- 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
Sites / Locations
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
- Novartis Investigator Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Canakinumab
Dexamethasone
Arm Description
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period
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 to Walk Independently (if Applicable) During Treatment Period
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.
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.
Change in Serum Amyloid A Protein (SAA) From Baseline at 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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00663169
Brief Title
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
Official Title
A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Gouty
Keywords
Arthritis Gouty, ACZ885, IL1B protein, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canakinumab
Arm Type
Experimental
Arm Description
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Intervention Type
Biological
Intervention Name(s)
canakinumab
Other Intervention Name(s)
ACZ885, Ilaris®
Intervention Description
10 mg/kg intravenous infusion 250 mL over 2 hours.
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
12 mg intravenous infusion 50 mL over 30 minutes.
Intervention Type
Other
Intervention Name(s)
placebo matching canakinumab
Intervention Description
5% glucose in water intravenous infusion.
Intervention Type
Other
Intervention Name(s)
placebo matching dexamethasone
Intervention Description
Placebo intravenous infusion.
Primary Outcome Measure Information:
Title
Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale
Description
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
Secondary Outcome Measure Information:
Title
Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period
Time Frame
72 hours
Title
Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period
Description
Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.
Time Frame
4 months
Title
Time to Walk Independently (if Applicable) During Treatment Period
Time Frame
4 months
Title
Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study
Description
Additional safety information can be found in the Adverse Event section.
Time Frame
4 months
Title
Change in C-reactive Protein (CRP) From Baseline at Month 4
Description
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
Title
Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4
Description
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
Title
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period
Description
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
Title
Change From Baseline in Pain Using a Visual Analog Scale at Month 4
Description
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
Title
Number of Patients Who Took Rescue Medication
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
score over 50 on the 0-100 VAS pain scale
acute, confirmed gout flare for no longer than 3 days
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis investigator site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigator Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Novartis Investigator Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Novartis Investigator Site
City
Lausanne
Country
Switzerland
Facility Name
Novartis Investigator Site
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
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