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Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study. (β-RELIEVED-II)

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ClinicalTrials.gov Identifier: NCT01080131
Recruitment Status : Completed
First Posted : March 3, 2010
Results First Posted : December 26, 2011
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Acute Gout
Interventions Drug: Canakinumab 150 mg
Drug: Triamcinolone acetonide 40 mg
Drug: Placebo to canakinumab
Drug: Placebo to triamcinolone acetonide
Enrollment 226
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description

Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study.

Period Title: Core Study (0- 12 Weeks)
Started 112 114
Completed 99 103
Not Completed 13 11
Reason Not Completed
Abnormal laboratory value(s)             1             1
Patient withdrew consent             6             4
Lost to Follow-up             5             3
Administrative problems             0             1
Death             1             0
Protocol deviation             0             2
Period Title: Extension Study 1 (12 -24 Weeks)
Started 84 76
Completed 78 72
Not Completed 6 4
Reason Not Completed
Adverse Event             1             0
Unsatisfactory Therapeutic Effect             0             1
Withdrawal by Subject             4             3
Lost to Follow-up             1             0
Period Title: Extension Study 2 (25-72 Weeks)
Started 72 65
Re-treated With or Switch to Canakinumab 62 [1] 41 [2]
Completed 64 54
Not Completed 8 11
Reason Not Completed
Adverse Event             1             2
Withdrawal by Subject             3             4
Lost to Follow-up             4             5
[1]
Includes patients re-treated with canakinumab at any time during the 72 weeks
[2]
Includes patients switched to canakinumab from Week 25 - Week 72
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg Total
Hide Arm/Group Description

Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study.

Total of all reporting groups
Overall Number of Baseline Participants 112 114 226
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 114 participants 226 participants
50.6  (12.10) 52.6  (12.28) 51.6  (12.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 114 participants 226 participants
Female
12
  10.7%
9
   7.9%
21
   9.3%
Male
100
  89.3%
105
  92.1%
205
  90.7%
1.Primary Outcome
Title Time to First New Flare: Survival Analysis During the 12 Weeks of Study
Hide Description Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely.
Time Frame Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Overall Number of Participants Analyzed 112 114
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
A median time to first new flare could not be estimated because <50% patients had a new flare during the time period.
2.Primary Outcome
Title Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose
Hide Description Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.
Time Frame 72 hours post-dose (randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Overall Number of Participants Analyzed 111 109
Least Squares Mean (Standard Error)
Unit of Measure: mm
22.1  (2.33) 31.9  (2.35)
3.Primary Outcome
Title Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks
Hide Description This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time Frame During 24 weeks overall
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Measure Type: Number
Unit of Measure: Participants
Adverse event 78 65
Death 1 0
Serious adverse event 7 2
4.Primary Outcome
Title Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)
Hide Description This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time Frame 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment.
Arm/Group Title All Canakinumab Canakinumab: Before Retreatment Canakinumab: After Retreatment All Triamcinolone Acetonide Triam: Before Switch to Canakinumab Triam: After Switch to Canakinumab
Hide Arm/Group Description:

Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.

In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months.

Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.

Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.

Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab.

Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
Overall Number of Participants Analyzed 112 62 62 114 41 41
Measure Type: Number
Unit of Measure: participants
Any adverse event 85 44 39 70 29 27
Death 1 0 0 0 0 0
Serious adverse event 12 1 5 4 0 3
5.Secondary Outcome
Title Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS)
Hide Description Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.
Time Frame Baseline to 7 days post-dose (randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Overall Number of Participants Analyzed 111 109
Median (95% Confidence Interval)
Unit of Measure: hours
25.0
(23.0 to 48.0)
48.0
(24.0 to 49.0)
6.Secondary Outcome
Title Time to Complete Resolution of Pain; Survival Analysis
Hide Description Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.
Time Frame Baseline to 7 days post-dose (randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All patients that received study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Overall Number of Participants Analyzed 112 114
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: hours
144.0 [1] 
(120 to NA)
NA [2] 
(168 to NA)
[1]
The upper limit was not estimable in the study as it is longer than duration of study.
[2]
The median time to complete resolution could not be estimated because <50% of patients had a complete resolution during the time period.
7.Secondary Outcome
Title SF 36 Physical Function Score at Week 12
Hide Description SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with observations at Week 12 were included in the analysis.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Overall Number of Participants Analyzed 83 81
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
81.46  (2.786) 78.75  (2.820)
8.Secondary Outcome
Title Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study
Hide Description The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Overall Number of Participants Analyzed 112 114
Measure Type: Number
Unit of Measure: percentage of participants
13.4 36.8
9.Secondary Outcome
Title Pharmacokinetic Concentrations
Hide Description Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL.
Time Frame 12 weeks post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg
Hide Arm/Group Description:
Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
Overall Number of Participants Analyzed 99
Mean (Standard Deviation)
Unit of Measure: µg/mL
2.16  (2.375)
10.Secondary Outcome
Title Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)
Hide Description Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.
Time Frame 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
Overall Number of Participants Analyzed 112 114
Least Squares Mean (Standard Error)
Unit of Measure: mm
6 hours post-dose 58.7  (1.94) 60.3  (1.96)
12 hours post-dose 50.8  (2.16) 52.0  (2.18)
24 hours post-dose 39.1  (2.39) 45.0  (2.41)
48 hours post-dose 29.5  (2.45) 38.9  (2.48)
72 hours post-dose 22.1  (2.33) 31.9  (2.35)
4 days post-dose 19.2  (2.25) 27.7  (2.27)
5 days post-dose 16.4  (2.23) 25.4  (2.25)
6 days post-dose 14.3  (2.20) 22.3  (2.22)
7 days post-dose 14.0  (2.18) 19.5  (2.20)
11.Secondary Outcome
Title Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)
Hide Description Patient’s assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates.
Time Frame 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. For assessments made up to 7 days after re-dosing, pain values were imputed using the Last- Observation-Carried-Forward (LOCF) method.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 25 46
Least Squares Mean (Standard Error)
Unit of Measure: mm
6 hours post-dose 57.4  (3.07) 59.1  (2.26)
12 hours post-dose 50.7  (4.24) 53.3  (3.12)
24 hours post-dose 46.2  (4.74) 43.8  (3.49)
48 hours post-dose 42.3  (4.96) 34.2  (3.65)
72 hours post-dose 37.0  (5.12) 26.1  (3.77)
4 days post-dose 31.3  (4.75) 23.4  (3.49)
5 days post-dose 29.0  (5.11) 21.6  (3.76)
6 days post-dose 28.1  (5.04) 20.5  (3.71)
7 days post-dose 24.1  (5.03) 19.1  (3.70)
12.Secondary Outcome
Title Time to the First New Gout Flare During 24 Weeks
Hide Description

Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had:

  • Flare in joint, not a previously affected joint (at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.

Time Frame From randomization to the end of the first extension period (24 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
146 [1] 
(94.0 to NA)
[1]
Not estimable due to the low number of events at the time of the assessment (24 weeks).
13.Secondary Outcome
Title Mean Number of New Gout Flares Per Patient During 24 Weeks
Hide Description

Patients met definition of new flare if they had:

  • Flare in joint, not a previously affected joint(at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Mean (Standard Deviation)
Unit of Measure: new flares per patient
0.35  (0.694) 0.80  (1.115)
14.Secondary Outcome
Title Time to First Intake of Rescue Medication
Hide Description

Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:

  • Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
  • If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.

Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.

Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks).

Time Frame For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. Patients who did not take rescue medication had the time-to-first rescue medication intake censored at 7 days post dosing and re-dosing.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Median (95% Confidence Interval)
Unit of Measure: hours
Baseline flare [N= 112, 114]
NA [1] 
(24 to NA)
37.5 [2] 
(14 to NA)
Last post-baseline flare [N=25, 46]
32 [2] 
(8.0 to NA)
NA [1] 
(12.0 to NA)
[1]
The data were not estimable as <50% patients took rescue medication
[2]
Upper bound did not cross the median value hence the upper limit was not estimable.
15.Secondary Outcome
Title Percentage of Participants Who Took Rescue Medication
Hide Description

Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:

  • Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
  • If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.

Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.

Time Frame For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Measure Type: Number
Unit of Measure: percentage of participants
Baseline flare [N= 112, 114] 43.8 57.0
Last post-baseline flare [N=25, 46] 56.0 41.3
16.Secondary Outcome
Title Amount of Rescue Medication Taken
Hide Description

Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:

  • Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
  • If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.
Time Frame For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Mean (Standard Deviation)
Unit of Measure: mg
Baseline flare: Acetaminophen [N=112, 114] 1375.0  (2726.63) 2526.5  (3925.13)
Baseline flare: Codeine [N=112, 114] 27.2  (100.40) 60.6  (144.38)
Baseline flare: Prednisone/Predinisone [N=112,114] 9.2  (35.32) 19.3  (44.88)
Last flare: Acetaminophen [N=25, 46] 2292.0  (3462.65) 1541.3  (3771.33)
Last flare: Codeine [N= 25, 46] 64.8  (224.11) 65.2  (178.70)
Last flare: Prednisolone/Predinisone [N= 25, 46] 5.6  (14.46) 18.3  (48.00)
17.Secondary Outcome
Title Physician’s Global Assessment of Response to Treatment
Hide Description The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient’s own assessments (pain intensity and patient’s global assessment of response to treatment).
Time Frame 72 hours post-dose and 24-weeks post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available for this endpoint at the specified time point.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - Very good [N= 107, 109] 43.0 25.7
72 hours - Good [N= 107, 109] 43.0 35.8
72 hours - Fair [N= 107, 109] 11.2 26.6
72 hours - Poor [N= 107, 109] 2.8 6.4
72 hours - Very poor [N= 107, 109] 0.0 5.5
24 weeks - Very good [N=79, 71] 77.2 66.2
24 weeks - Good [N=79, 71] 16.5 29.6
24 weeks - Fair [N=79, 71] 5.1 4.2
24 weeks - Poor [N=79, 71] 1.3 0.0
24 weeks - Very poor [N=79, 71] 0.0 0.0
18.Secondary Outcome
Title Patient’s Global Assessment of Response to Treatment
Hide Description Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported.
Time Frame 72 hours post-dose and 24 weeks post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - Excellent [N=108, 108] 36.1 19.4
72 hours - Good [N=108, 108] 37.0 32.4
72 hours - Acceptable [N=108, 108] 18.5 13.9
72 hours - Slight [N=108, 108] 4.6 25.0
72 hours - Poor [N=108, 108] 3.7 9.3
24 weeks - Excellent [N=79, 72] 59.5 40.3
24 weeks - Good [N=79, 72] 26.6 44.4
24 weeks - Acceptable [N=79, 72] 6.3 13.9
24 weeks - Slight [N=79, 72] 6.3 1.4
24 weeks - Poor [N=79, 72] 1.3 0.0
19.Secondary Outcome
Title Physician’s Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint
Hide Description The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that “there is pain”, patient states “there is pain and winces”, and patient states “there is pain, winces, and withdraws” on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported.
Time Frame 72 hours post-dose and 24 weeks post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - Tenderness: No pain [N=107, 109] 47.7 30.3
72 hours - Tenderness: Pain [N=107, 109] 43.9 46.8
72 hours - Tenderness: Pain & winces [N=107, 109] 4.7 14.7
72 hours - Tenderness:Winces/withdraws [N=107,109] 3.7 8.3
24 weeks - Tenderness: No pain [N=79, 71] 88.6 91.5
24 weeks - Tenderness: Pain [N=79, 71] 8.9 5.6
24 weeks - Tenderness: Pain and winces [N=79, 71] 1.3 1.4
24 weeks - Tenderness: Winces/withdraws [N=79, 71] 1.3 1.4
72 hours - Swelling: No swelling [N=107,109] 47.7 35.8
72 hours - Swelling: Palpable [N=107,109] 28.0 29.4
72 hours - Swelling: Visible [N=107,109] 22.4 28.4
72 hours - Swelling: Bulging [N=107,109] 1.9 6.4
24 weeks - Swelling: No swelling [N=79, 71] 93.7 94.4
24 weeks - Swelling: Palpable [N=79, 71] 5.1 4.2
24 weeks - Swelling: Visible [N=79, 71] 1.3 1.4
24 weeks - Swelling: Bulging [N=79, 71] 0.0 0.0
72 hours - Erythema: Absent [N=107, 108] 74.8 66.7
72 hours - Erythema: Present [N=107, 108] 25.2 33.3
24 weeks - Erythema: Absent [N=79, 71] 97.5 97.2
24 weeks - Erythema: Present [N=79, 71] 2.5 2.8
20.Secondary Outcome
Title Physician’s Assessment of Range of Motion of the Most Affected Joint
Hide Description The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported.
Time Frame 72 hours post-dose and 24 weeks post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - Normal [N=107,109] 47.7 28.4
72 hours - Mildly restricted [N=107,109] 37.4 45.9
72 hours - Moderately restricted [N=107,109] 13.1 20.2
72 hours - Severely restricted [N=107,109] 1.9 5.5
72 hours - Immobilized [N=107,109] 0.0 0.0
24 weeks - Normal [N=79, 71] 86.1 97.2
24 weeks - Mildly restricted [N=79, 71] 10.1 2.8
24 weeks - Moderately restricted [N=79, 71] 2.5 0.0
24 weeks - Severely restricted [N=79, 71] 1.3 0.0
24 weeks - Immobilized [N=79, 71] 0.0 0.0
21.Secondary Outcome
Title High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels
Hide Description High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.
Time Frame 72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. "N" indicates the number of participants with available data in each analysis.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/L
Baseline flare: hsCRP [N=107, 110]
3.84
(3.26 to 4.53)
6.38
(5.43 to 7.50)
Baseline flare: SAA [N=95, 104]
6.31
(4.95 to 8.04)
15.85
(12.58 to 19.98)
Last post-baseline flare: hsCRP [N= 22, 42]
3.69
(2.44 to 5.60)
4.32
(3.23 to 5.60)
Last post-baseline flare: SAA, [N= 19, 39]
6.74
(3.56 to 12.78)
11.04
(7.17 to 17.02)
22.Secondary Outcome
Title Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
Hide Description Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme).
Time Frame 72 hours post-dose and 24 weeks post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 112 114
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - None [N=108, 111] 30.6 18.0
72 hours - Mild [N=108, 111] 48.1 45.0
72 hours - Moderate [N=108, 111] 20.4 27.0
72 hours - Severe [N=108, 111] 0.9 8.1
72 hours - Extreme [N=108, 111] 0.0 1.8
24 weeks - None [N=79, 70] 72.2 67.1
24 weeks - Mild [N=79, 70] 19.0 25.7
24 weeks - Moderate [N=79, 70] 6.3 7.1
24 weeks - Severe [N=79, 70] 2.5 0.0
24 weeks - Extreme [N=79, 70] 0.0 0.0
23.Secondary Outcome
Title Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme
Hide Description For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period.
Time Frame From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed (indicated by 'N') for the first new post-baseline flare includes patients who were re-treated for a new flare during the 12-week core study. For the last post-baseline flare the population analyzed includes patients re-treated for at least one new flare during the first 24 weeks.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

Overall Number of Participants Analyzed 25 46
Measure Type: Number
Unit of Measure: Percentage of participants
First post-baseline flare [N= 12, 37] 66.7 78.4
Last post-baseline flare [N= 25, 46] 64.0 78.3
24.Secondary Outcome
Title Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks
Hide Description

Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).

Patients met definition of new flare if they had:

  • Flare in joint, not a previously affected joint (at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Patients did not meet criterion of having new gout flare if:

• Increasing/renewed gout pain in an affected joint before flare has resolved completely.

Time Frame From randomization to the end of the second extension period (72 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:

Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study.

Overall Number of Participants Analyzed 112 114
Median (95% Confidence Interval)
Unit of Measure: days
254.0
(209.0 to 284.0)
146.0
(94.0 to 202.0)
25.Secondary Outcome
Title Flare Rate Per Year
Hide Description

Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.

Participants met the definition of new flare if they had:

  • Flare in joint, not a previously affected joint (at baseline or during study)
  • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

Participants did not meet criterion of having new gout flare if:

• Increasing/renewed gout pain in an affected joint before the flare has resolved completely.

Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate.

Time Frame From randomization to the end of the second extension period (72 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug.
Arm/Group Title Canakinumab 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:

Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months.

Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.

In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study.

Overall Number of Participants Analyzed 112 114
Mean (95% Confidence Interval)
Unit of Measure: flares per patient per year
1.18
(0.96 to 1.45)
2.02
(1.65 to 2.47)
26.Secondary Outcome
Title Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab
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Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme).

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Time Frame 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
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Hide Analysis Population Description
Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Re-treated With Canakinumab 150 mg Triam Switched to Canakinumab
Hide Arm/Group Description:
Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
Overall Number of Participants Analyzed 62 41
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - None [N=59, 40] 30.5 25.0
72 hours - Mild [N=59, 40] 44.1 62.5
72 hours - Moderate [N=59, 40] 22.0 12.5
72 hours - Severe [N=59, 40] 3.4 0.0
72 hours - Extreme [N=59, 40] 0.0 0.0
7 days - None [N=57, 37] 64.9 59.5
7 days - Mild [N=57, 37] 21.1 35.1
7 days - Moderate [N=57, 37] 10.5 5.4
7 days - Severe [N=57, 37] 3.5 0.0
7 days - Extreme [N=57, 37] 0.0 0.0
27.Secondary Outcome
Title Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab
Hide Description Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
Time Frame 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Re-treated With Canakinumab 150 mg Triam Switched to Canakinumab
Hide Arm/Group Description:
Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
Overall Number of Participants Analyzed 62 41
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - Excellent [N=58, 38] 41.4 36.8
72 hours - Good [N=58, 38] 32.8 39.5
72 hours - Acceptable [N=58, 38] 12.1 21.1
72 hours - Slight [N=58, 38] 13.8 2.6
72 hours - Poor [N=58, 38] 0.0 0.0
7 days - Excellent [N=56, 39] 51.8 51.3
7 days - Good [N=56, 39] 26.8 33.3
7 days - Acceptable [N=56, 39] 10.7 7.7
7 days - Slight [N=56, 39] 7.1 7.7
7 days - Poor [N=56, 39] 3.6 0.0
28.Secondary Outcome
Title Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab
Hide Description

The study physician made a global assessment of the patient’s response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor.

The physician completed the physician’s global assessment of response to treatment without viewing any of the patient’s assessments.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Time Frame 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Re-treated With Canakinumab 150 mg Triam Switched to Canakinumab
Hide Arm/Group Description:
Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
Overall Number of Participants Analyzed 62 41
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - Very good [N=56, 38] 39.3 42.1
72 hours - Good [N=56, 38] 39.3 39.5
72 hours - Fair [N=56, 38] 16.1 18.4
72 hours - Poor [N=56, 38] 5.4 0.0
72 hours - Very poor [N=56, 38] 0.0 0.0
7 days - Very good [N=58, 39] 56.9 59.0
7 days - Good [N=58, 39] 25.9 38.5
7 days - Fair [N=58, 39] 15.5 2.6
7 days - Poor [N=58, 39] 1.7 0.0
7 days - Very poor [N=58, 39] 0.0 0.0
29.Secondary Outcome
Title Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab
Hide Description

The study physician assessed the most affected joint for tenderness on the following 4-point scale:

  • no pain;
  • participant states that "there is pain;
  • participant states "there is pain and winces";
  • participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Time Frame 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Re-treated With Canakinumab 150 mg Triam Switched to Canakinumab
Hide Arm/Group Description:
Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
Overall Number of Participants Analyzed 62 41
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - No pain [N=56, 38] 51.8 42.1
72 hours - Pain [N=56, 38] 37.5 50.0
72 hours - Pain and winces [N=56, 38] 5.4 5.3
72 hours - Pain, winces and withdraws [N=56, 38] 5.4 2.6
7 days - No pain [N=58, 39] 74.1 79.5
7 days - Pain [N=58, 39] 22.4 20.5
7 days - Pain and winces [N=58, 39] 3.4 0.0
7 days - Pain, winces and withdraws [N=58, 39] 0.0 0.0
30.Secondary Outcome
Title Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab
Hide Description

The study physician assessed the most affected joint for swelling on the following 4-point scale:

  • no swelling;
  • palpable;
  • visible;
  • bulging beyond the joint margins.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Time Frame 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Re-treated With Canakinumab 150 mg Triam Switched to Canakinumab
Hide Arm/Group Description:
Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
Overall Number of Participants Analyzed 62 41
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - No swelling [N=56, 38] 55.4 47.4
72 hours - Palpable [N=56, 38] 26.8 34.2
72 hours - Visible [N=56, 38] 12.5 15.8
72 hours - Bulging beyond joint margins [N=56, 38] 5.4 2.6
7 days - No swelling [N=58, 39] 70.7 79.5
7 days - Palpable [N=58, 39] 17.2 17.9
7 days - Visible [N=58, 39] 10.3 2.6
7 days - Bulging beyond joint margins [N=58, 39] 1.7 0.0
31.Secondary Outcome
Title Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab
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The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Time Frame 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Re-treated With Canakinumab 150 mg Triam Switched to Canakinumab
Hide Arm/Group Description:
Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
Overall Number of Participants Analyzed 62 41
Measure Type: Number
Unit of Measure: percentage of participants
72 hours - Absent [N=56, 38] 73.2 92.1
72 hours - Present [N=56, 38] 26.8 7.9
7 days - Absent [N=58, 39] 84.5 94.9
7 days - Present [N=58, 39] 15.5 5.1
32.Secondary Outcome
Title High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab
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High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Time Frame 24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Re-treated With Canakinumab 150 mg Triam Switched to Canakinumab
Hide Arm/Group Description:
Participants who received canakinumab 150 mg in the Ccre study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
Overall Number of Participants Analyzed 62 41
Mean (Standard Deviation)
Unit of Measure: mg/L
24-hours post-dose [N=48, 36] 30.1  (64.11) 39.4  (41.10)
72-hours post-dose [N=56, 38] 10.4  (31.11) 12.6  (15.80)
7 days post-dose [N=55, 40] 2.8  (4.97) 3.5  (5.00)
4 weeks post-dose [N=46, 37] 1.6  (2.30) 2.2  (3.54)
8 weeks post-dose [N=37, 35] 2.1  (4.41) 2.4  (4.62)
12 weeks post-dose [N=38, 31] 1.3  (0.79) 2.9  (4.90)
33.Secondary Outcome
Title Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab
Hide Description

Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.

Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

Time Frame 24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Arm/Group Title Re-treated With Canakinumab 150 mg Triam Switched to Canakinumab
Hide Arm/Group Description:
Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
Overall Number of Participants Analyzed 62 41
Mean (Standard Deviation)
Unit of Measure: mg/L
24-hours post-dose [N=47, 36] 129.0  (324.45) 145.9  (257.44)
72-hours post-dose [N=54, 37] 45.6  (163.45) 45.4  (97.00)
7 days post-dose [N=56, 39] 5.7  (8.90) 5.9  (8.34)
4 weeks post-dose [N=47, 37] 3.4  (3.67) 5.0  (7.02)
8 weeks post-dose [N=38, 35] 3.5  (4.24) 5.3  (13.41)
12 weeks post-dose [N=38, 29] 3.4  (2.37) 4.8  (5.94)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Canakinumab Canakinumab: Before Retreatment Canakinumab: After Retreatment All Triamcinolone Acetonide Triam: Before Switch to Canakinumab Triam: After Switch to Canakinumab
Hide Arm/Group Description

Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.

In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.

In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months.

Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab. Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.

Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.

Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab.

Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab. Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
All-Cause Mortality
All Canakinumab Canakinumab: Before Retreatment Canakinumab: After Retreatment All Triamcinolone Acetonide Triam: Before Switch to Canakinumab Triam: After Switch to Canakinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Canakinumab Canakinumab: Before Retreatment Canakinumab: After Retreatment All Triamcinolone Acetonide Triam: Before Switch to Canakinumab Triam: After Switch to Canakinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/112 (10.71%)   1/62 (1.61%)   5/62 (8.06%)   4/114 (3.51%)   0/41 (0.00%)   3/41 (7.32%) 
Blood and lymphatic system disorders             
Anaemia  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Haemorrhagic anaemia  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Cardiac disorders             
Angina pectoris  1  1/112 (0.89%)  0/62 (0.00%)  1/62 (1.61%)  0/114 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Aortic valve incompetence  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  1/114 (0.88%)  0/41 (0.00%)  0/41 (0.00%) 
Atrial fibrillation  1  1/112 (0.89%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Cardiomyopathy  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  1/114 (0.88%)  0/41 (0.00%)  0/41 (0.00%) 
Congenital, familial and genetic disorders             
Bicuspid aortic valve  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  1/114 (0.88%)  0/41 (0.00%)  0/41 (0.00%) 
Gastrointestinal disorders             
Diarrhoea  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  1/114 (0.88%)  0/41 (0.00%)  0/41 (0.00%) 
Lower gastrointestinal haemorrhage  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Nausea  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  1/114 (0.88%)  0/41 (0.00%)  0/41 (0.00%) 
Pancreatitis  1  1/112 (0.89%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Vomiting  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  1/114 (0.88%)  0/41 (0.00%)  0/41 (0.00%) 
General disorders             
Cyst  1  1/112 (0.89%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Infections and infestations             
Abscess limb  1  2/112 (1.79%)  1/62 (1.61%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Gastroenteritis  1  1/112 (0.89%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Metabolism and nutrition disorders             
Diabetes mellitus  1  1/112 (0.89%)  0/62 (0.00%)  1/62 (1.61%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain  1  1/112 (0.89%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Intervertebral disc protrusion  1  1/112 (0.89%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Prostate cancer  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  1/114 (0.88%)  0/41 (0.00%)  0/41 (0.00%) 
Squamous cell carcinoma  1  1/112 (0.89%)  0/62 (0.00%)  1/62 (1.61%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Nervous system disorders             
Cerebrovascular accident  1  1/112 (0.89%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Convulsion  1  1/112 (0.89%)  0/62 (0.00%)  1/62 (1.61%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Haemorrhage intracranial  1  1/112 (0.89%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Trigeminal neuralgia  1  1/112 (0.89%)  0/62 (0.00%)  1/62 (1.61%)  0/114 (0.00%)  0/41 (0.00%)  0/41 (0.00%) 
Psychiatric disorders             
Alcohol withdrawal syndrome  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  1/114 (0.88%)  0/41 (0.00%)  0/41 (0.00%) 
Renal and urinary disorders             
Acute prerenal failure  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  0/114 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Vascular disorders             
Aortic stenosis  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  1/114 (0.88%)  0/41 (0.00%)  0/41 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Canakinumab Canakinumab: Before Retreatment Canakinumab: After Retreatment All Triamcinolone Acetonide Triam: Before Switch to Canakinumab Triam: After Switch to Canakinumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   42/112 (37.50%)   15/62 (24.19%)   19/62 (30.65%)   36/114 (31.58%)   15/41 (36.59%)   8/41 (19.51%) 
Gastrointestinal disorders             
Nausea  1  3/112 (2.68%)  2/62 (3.23%)  1/62 (1.61%)  3/114 (2.63%)  1/41 (2.44%)  3/41 (7.32%) 
Infections and infestations             
Nasopharyngitis  1  0/112 (0.00%)  0/62 (0.00%)  0/62 (0.00%)  5/114 (4.39%)  4/41 (9.76%)  2/41 (4.88%) 
Upper respiratory tract infection  1  9/112 (8.04%)  4/62 (6.45%)  7/62 (11.29%)  3/114 (2.63%)  1/41 (2.44%)  1/41 (2.44%) 
Injury, poisoning and procedural complications             
Muscle strain  1  1/112 (0.89%)  0/62 (0.00%)  0/62 (0.00%)  3/114 (2.63%)  3/41 (7.32%)  3/41 (7.32%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  8/112 (7.14%)  1/62 (1.61%)  5/62 (8.06%)  10/114 (8.77%)  3/41 (7.32%)  2/41 (4.88%) 
Back pain  1  12/112 (10.71%)  2/62 (3.23%)  6/62 (9.68%)  2/114 (1.75%)  1/41 (2.44%)  0/41 (0.00%) 
Muscle spasms  1  4/112 (3.57%)  2/62 (3.23%)  1/62 (1.61%)  7/114 (6.14%)  4/41 (9.76%)  0/41 (0.00%) 
Pain in extremity  1  2/112 (1.79%)  1/62 (1.61%)  0/62 (0.00%)  6/114 (5.26%)  4/41 (9.76%)  1/41 (2.44%) 
Nervous system disorders             
Headache  1  5/112 (4.46%)  3/62 (4.84%)  2/62 (3.23%)  6/114 (5.26%)  2/41 (4.88%)  1/41 (2.44%) 
Vascular disorders             
Hypertension  1  14/112 (12.50%)  3/62 (4.84%)  7/62 (11.29%)  7/114 (6.14%)  2/41 (4.88%)  1/41 (2.44%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
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Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01080131     History of Changes
Obsolete Identifiers: NCT01137344, NCT01194921
Other Study ID Numbers: CACZ885H2357
2010-018913-32 ( EudraCT Number )
CACZ885H2357E1 ( Other Identifier: Novartis )
First Submitted: March 2, 2010
First Posted: March 3, 2010
Results First Submitted: August 30, 2011
Results First Posted: December 26, 2011
Last Update Posted: January 30, 2014