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Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

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ClinicalTrials.gov Identifier: NCT01362608
Recruitment Status : Terminated
First Posted : May 30, 2011
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gouty Arthritis
Interventions Drug: Canakinumab, ACZ885
Drug: Triamcinolone acetonide
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Period Title: Overall Study
Started 67 69
Completed 63 61
Not Completed 4 8
Reason Not Completed
Protocol Violation             0             1
Lost to Follow-up             3             1
Withdrawal by Subject             1             2
Lack of Efficacy             0             2
Adverse Event             0             2
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg Total
Hide Arm/Group Description Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. Total of all reporting groups
Overall Number of Baseline Participants 67 69 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 136 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
58
  86.6%
66
  95.7%
124
  91.2%
>=65 years
9
  13.4%
3
   4.3%
12
   8.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 69 participants 136 participants
50.2  (11.98) 49.2  (11.37) 49.7  (11.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 69 participants 136 participants
Female
1
   1.5%
2
   2.9%
3
   2.2%
Male
66
  98.5%
67
  97.1%
133
  97.8%
1.Primary Outcome
Title The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
Hide Description A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 – 4 mm), mild pain (5– 44 mm), moderate pain (45–74 mm), and severe pain (75– 100 mm)
Time Frame at 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
18.2  (3.03) 37.9  (3.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACZ885 150 mg, Triamcinolone Acetonide 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.69
Confidence Interval (2-Sided) 95%
-28.2 to -11.2
Estimation Comments [Not Specified]
2.Primary Outcome
Title Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
Hide Description Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Participants
5
(1.19 to 13.93)
17
(15.29 to 36.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACZ885 150 mg, Triamcinolone Acetonide 40 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0043
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
0.10 to 0.71
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Number of Patients With at Least 1 New Gout Flare
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants
1 new flare 3 15
2 new flares 0 1
3 new flares 0 0
> 3 new flares 2 1
4.Secondary Outcome
Title Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0–100mm VAS): Summary Statistics by Timepoint and Treatment
Hide Description A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 – 4 mm), mild pain (5– 44 mm), moderate pain (45–74 mm), and severe pain (75– 100 mm)
Time Frame baseline through 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Mean (Standard Deviation)
Unit of Measure: unit on a scale
baseline 72.3  (13.18) 74.5  (12.88)
6 hours post-dose 53.0  (22.06) 58.8  (23.83)
12 hours post-dose 41.7  (19.56) 51.8  (27.07)
24 hours post-dose 30.9  (18.23) 48.6  (29.13)
48 hours post-dose 22.0  (18.64) 43.9  (30.69)
72 hours post-dose 17.4  (17.02) 36.6  (30.62)
7 days post-dose 10.1  (15.61) 24.0  (27.31)
4 weeks post-dose 9.5  (17.25) 17.9  (25.31)
8 weeks post-dose 6.8  (13.64) 16.0  (24.24)
12 weeks post-dose 6.8  (12.92) 13.0  (19.77)
5.Secondary Outcome
Title Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
Hide Description Patients will score 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 baseline through week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants
baseline none 0 0
baseline mild 2 3
baseline moderate 25 18
baseline severe 37 44
baseline extreme 3 4
6 hours post-dose none 0 0
6 hours post-dose mild 18 14
6 hours post-dose moderate 28 26
6 hours post-dose severe 17 29
6 hours post-dose extreme 2 0
12 hours post-dose none 1 2
12 hours post-dose mild 28 19
12 hours post-dose moderate 28 26
12 hours post-dose severe 7 21
12 hours post-dose extreme 1 1
24 hours post-dose none 3 4
24 hours post-dose mild 40 20
24 hours post-dose moderate 19 25
24 hours post-dose severe 2 20
24 hours post-dose extreme 1 0
48 hours post-dose none 10 10
48 hours post-dose mild 48 21
48 hours post-dose moderate 7 20
48 hours post-dose severe 2 14
48 hours post-dose extreme 0 2
72 hours post-dose none 14 12
72 hours post-dose mild 45 26
72 hours post-dose moderate 8 16
72 hours post-dose severe 0 9
72 hours post-dose extreme 0 4
4 days post-dose none 21 14
4 days post-dose mild 39 29
4 days post-dose moderate 7 13
4 days post-dose severe 0 10
4 days post-dose extreme 0 0
7 days post-dose none 32 23
7 days post-dose mild 29 25
7 days post-dose moderate 5 10
7 days post-dose severe 1 8
7 days post-dose extreme 0 0
4 weeks post-dose none 43 24
4 weeks post-dose mild 17 25
4 weeks post-dose moderate 4 6
4 weeks post-dose severe 1 0
4 weeks post-dose extreme 0 0
8 weeks post-dose none 39 30
8 weeks post-dose mild 22 21
8 weeks post-dose moderate 2 6
8 weeks post-dose severe 2 2
8 weeks post-dose extreme 0 0
12 weeks post-dose none 41 25
12 weeks post-dose mild 18 28
12 weeks post-dose moderate 3 8
12 weeks post-dose severe 2 1
12 weeks post-dose extreme 0 1
6.Secondary Outcome
Title Patient’s Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
Hide Description Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).
Time Frame 72 hours through week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants
72 hours post-dose excellent 7 3
72 hours post-dose good 40 17
72 hours post-dose acceptable 14 18
72 hours post-dose slight 4 11
72 hours post-dose poor 1 10
72 hours post-dose very poor 0 0
72 hours post-dose not done 0 1
7 days post-dose excellent 16 4
7 days post-dose good 38 20
7 days post-dose acceptable 9 18
7 days post-dose slight 1 7
7 days post-dose poor 1 16
7 days post-dose very poor 0 0
7 days post-dose not done 0 1
4 weeks post-dose excellent 15 6
4 weeks post-dose good 33 19
4 weeks post-dose acceptable 13 14
4 weeks post-dose slight 4 7
4 weeks post-dose poor 0 9
4 weeks post-dose very poor 0 0
4 weeks post-dose not done 0 2
8 weeks post-dose excellent 18 8
8 weeks post-dose good 35 16
8 weeks post-dose acceptable 10 18
8 weeks post-dose slight 2 9
8 weeks post-dose poor 0 8
8 weeks post-dose very poor 0 0
8 weeks post-dose not done 0 1
12 weeks post-dose excellent 16 4
12 weeks post-dose good 37 21
12 weeks post-dose acceptable 10 21
12 weeks post-dose slight 0 7
12 weeks post-dose poor 1 9
12 weeks post-dose very poor 0 0
12 weeks post-dose not done 3 3
7.Secondary Outcome
Title Physician’s Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Hide Description Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
Time Frame baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants
Baseline no pain 0 0
Baseline pain 15 16
Baseline pain and winces 31 29
Baseline pain, winces and withdraws 21 24
Baseline not assessed 0 0
72 hours post-dose no pain 23 16
72 hours post-dose pain 37 26
72 hours post-dose pain and winces 5 11
72 hours post-dose pain, winces and withdraws 1 3
72 hours post-dose not assessed 0 0
7 days post-dose no pain 41 26
7 days post-dose pain 23 27
7 days post-dose pain and winces 2 10
7 days post-dose pain , winces and withdraws 0 2
7 days post-dose not assessed 0 0
4 weeks post-dose no pain 54 30
4 weeks post-dose pain 10 19
4 weeks post-dose pain and winces 1 3
4 weeks post-dose pain, winces and withdraws 0 3
4 weeks post-dose not assessed 0 0
8 weeks post-dose no pain 54 38
8 weeks post-dose pain 11 19
8 weeks post-dose pain and winces 0 1
8 weeks post-dose pain winces and withdraws 0 1
8 weeks post-dose not assessed 0 0
12 weeks post-dose no pain 53 39
12 weeks post-dose pain 7 22
12 weeks post-dose pain and winces 2 1
12 weeks post-dose pain, winces and withdraws 2 0
12 weeks post-dose not assessed 0 0
8.Secondary Outcome
Title Physician’s Assessment of Swelling: Frequency Table by Timepoint and Treatment
Hide Description Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
Time Frame baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants
Baseline No swelling 1 3
Baseline Palpable 13 12
Baseline Visible 29 39
Baseline Bulging beyond the joint margins 24 15
Baseline not assessed 0 0
72 hours post-dose No swelling 38 22
72 hours post-dose Palpable 15 15
72 hours post-dose Visible 12 18
72 hrs post-dose Bulging beyond the joint margins 1 1
72 hours post-dose not assessed 0 0
7 days post-dose No swelling 53 35
7 days post-dose Palpable 9 18
7 days post-dose Visible 3 9
7 days post-dose Bulging beyond the joint margins 1 3
7 days post-dose not assessed0 0 0
4 weeks post-dose No swelling 60 40
4 weeks post-dose Palpable 2 9
4 weeks post-dose Visible 3 4
4 weeks post-dose Bulging beyond the joint margins 0 2
4 weeks post-dose not assessed 0 0
8 weeks post-dose No swelling 63 49
8 weeks post-dose Palpable 0 6
8 weeks post-dose Visible 2 4
8 weeks post-dose Bulging beyond the joint margins 0 0
8 weeks post-dose not assessed 0 0
12 weeks post-dose No swelling 61 52
12 weeks post-dose Palpable 1 6
12 weeks post-dose Visible 2 2
12 wks post-dose Bulging beyond the joint margins 0 2
12 weeks post-dose not assessed 0 0
9.Secondary Outcome
Title Physician’s Assessment of Erythema: Frequency Table by Timepoint and Treatment
Hide Description Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).
Time Frame baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants
Baseline Absent 19 19
Baseline present 48 50
Baseline not assessed 0 0
Baseline not assessable 0 0
72 hours post-dose absent 54 41
72 hours post-dose present 11 15
72 hours post-dose not assessed 0 0
72 hrs post-dose not assessable 1 0
7 days post-dose absent 62 57
7 days post-dose present 3 8
7 days post-dose not assessed 0 0
7 days post-dose not assessable 1 0
4 weeks post-dose absent 63 49
4 weeks post-dose present 1 6
4 weeks post-dose not assessed 0 0
4 weeks post-dose not assessable 1 0
8 weeks post-dose absent 65 56
8 weeks post-dose present 0 3
8 weeks post-dose not assessed 0 0
8 weeks post-dose not assessable 0 0
12 weeks post-dose absent 62 61
12 weeks post-dose present 1 1
12 weeks post-dose not assessed 0 0
12 wks post-dose not assessable 1 0
10.Secondary Outcome
Title Physician’s Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
Hide Description Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).
Time Frame baseline through week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: participants
baseline normal 0 0
baseline mildly restricted 3 6
baseline moderately restricted 32 24
baseline severely restricted 27 39
baseline immobilzed 5 0
72 hours post-dose normal 20 15
72 hours post-dose mildly restricted 33 19
72 hours post-dose moderately restricted 11 14
72 hours post-dose severely restricted 2 7
72 hours post-dose immobilized 0 1
7 days post-dose normal 35 26
7 days post-dose mildly restricted 25 20
7 days post-dose moderately restricted 4 15
7 days post-dose severely restricted 1 3
7 days post-dose immobilized 0 1
4 weeks post-dose normal 49 25
4 weeks post-dose mildly restricted 12 22
4 weeks post-dose moderately restricted 3 7
4 weeks post-dose severely restricted 1 1
4 weeks post-dose immobilized 0 0
8 weeks post-dose normal 51 32
8 weeks post-dose mildly restricted 12 18
8 weeks post-dose moderately restricted 1 6
8 weeks post-dose severely restricted 1 3
8 weeks post-dose immobilized 0 0
12 weeks post-dose normal 50 30
12 weeks post-dose mildly restrcted 1 23
12 weeks post-dose moderately restricted 2 6
12 weeks post-dose severely restricted 1 3
12 weeks post-dose immobilized 0 0
11.Secondary Outcome
Title Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
Hide Description Kaplan Meier estimate
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Median (95% Confidence Interval)
Unit of Measure: hours
24.0
(24.0 to 48.0)
48.0
(24.0 to 72.0)
12.Secondary Outcome
Title Time to Complete Resolution of Pain: Survival Analysis by Treatment
Hide Description Kaplan Meier estimate
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Median (95% Confidence Interval)
Unit of Measure: hours
168.0
(120.0 to 168.0)
168.0 [1] 
(NA to NA)
[1]
CI cannot calculated for this parameter as it is “too narrow to exist”. The CI limits are time points where events happened or censored. When we decrease the confidence level from 99% to 95%, no observed time point meets the criterion.
13.Secondary Outcome
Title Time to First Rescue Medication Intake
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Mean (Standard Deviation)
Unit of Measure: hours
31.8  (30.45) 41.5  (38.8)
14.Secondary Outcome
Title Percent Patients Who Took Rescue Medication
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Measure Type: Number
Unit of Measure: percentage
Baseline flare (n= 29,42) 43.3 60.9
Last post-baseline flare (n=3,4) 75.0 44.4
15.Secondary Outcome
Title Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Hide Description Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Mean (Standard Deviation)
Unit of Measure: mg
Baseline flare Paracetamol / acetaminophen 342.5  (680.53) 451.4  (744.19)
Baseline flare Prednisolol 1.1  (4.25) 5.0  (15.29)
Baseline Flare Prednisone 0.7  (5.52) 5.2  (30.42)
Baseline flare Codeine 0.0  (0.00) 0.4  (3.61)
Last post-baseline flare Paraceta/acetamin n=4,9 287.5  (337.58) 222.2  (666.67)
Last post-baseline flare Prednisolone n=4,9 5.0  (10.00) 4.4  (8.82)
Last post-baseline flare Prednisone n=4,9 0.0  (0.00) 0.6  (1.67)
16.Secondary Outcome
Title High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose
Hide Description [Not Specified]
Time Frame 72 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACZ885 150 mg Triamcinolone Acetonide 40 mg
Hide Arm/Group Description:
Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
Overall Number of Participants Analyzed 67 69
Mean (95% Confidence Interval)
Unit of Measure: mg/L
5.5
(4.4 to 6.9)
7.2
(5.7 to 9.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACZ885 150mg sc Triam 40mg im
Hide Arm/Group Description ACZ885 150mg sc Triam 40mg im
All-Cause Mortality
ACZ885 150mg sc Triam 40mg im
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ACZ885 150mg sc Triam 40mg im
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   1/69 (1.45%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  0/67 (0.00%)  1/69 (1.45%) 
Musculoskeletal and connective tissue disorders     
Gouty arthritis  1  0/67 (0.00%)  1/69 (1.45%) 
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%
ACZ885 150mg sc Triam 40mg im
Affected / at Risk (%) Affected / at Risk (%)
Total   0/67 (0.00%)   4/69 (5.80%) 
Vascular disorders     
Hypertension  1  0/67 (0.00%)  4/69 (5.80%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
This study was terminated early. The decision to terminate study was not out of concerns for efficacy or safety of canakinumab
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
Layout table for Results Point of Contact information
Name/Title: Clinical Disclosure Office
Organization: Novartis
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01362608     History of Changes
Other Study ID Numbers: CACZ885H2358
2010-024172-26
First Submitted: May 24, 2011
First Posted: May 30, 2011
Results First Submitted: May 19, 2016
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017