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Trial record 31 of 75 for:    "Collagen Disease" | "Triamcinolone"

Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

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ClinicalTrials.gov Identifier: NCT01356602
Recruitment Status : Completed
First Posted : May 19, 2011
Results First Posted : January 29, 2014
Last Update Posted : January 29, 2014
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 Acute Gouty Arthritis
Interventions Drug: Canakinumab pre-filled syringe
Drug: Canakinumab lyophilized powder
Drug: Triamcinolone Acetonide
Drug: Placebo
Enrollment 397
Recruitment Details  
Pre-assignment Details Number of subjects randomized was 397. Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to a safety set of 399 subjects. Subjects who did not receive study drug were excluded from analysis.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug. The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug. The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Period Title: Overall Study
Started 133 132 132
Safety Set 133 [1] 133 [2] 133 [2]
Full Analysis Set 131 129 129
Completed 124 117 108
Not Completed 9 15 24
Reason Not Completed
Protocol Deviation             0             1             1
Administrative Problems             1             4             5
Lost to Follow-up             4             5             6
Withdrawal by Subject             4             3             7
Lack of Efficacy             0             1             4
Adverse Event             0             1             1
[1]
In this arm, 1 patient had only 3 placebo injections and 3 patients also took other active drug.
[2]
In this arm, 3 patients also took other active drug.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide Total
Hide Arm/Group Description Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug. The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug. The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug. Total of all reporting groups
Overall Number of Baseline Participants 133 133 133 399
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 133 participants 133 participants 133 participants 399 participants
53.4  (11.21) 53  (11.84) 53.7  (11.33) 53.5  (11.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 133 participants 133 participants 399 participants
Female
15
  11.3%
9
   6.8%
11
   8.3%
35
   8.8%
Male
118
  88.7%
124
  93.2%
122
  91.7%
364
  91.2%
1.Primary Outcome
Title Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
Hide Description The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
Time Frame 72 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 130 0 126
Least Squares Mean (Standard Error)
Unit of Measure: Millimeters
17.1  (2.04) 32  (2.08)
2.Secondary Outcome
Title Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups
Hide Description The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
Time Frame 72 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 130 129 0
Least Squares Mean (Standard Error)
Unit of Measure: Millimeters
17.1  (2.04) 19.7  (2.05)
3.Secondary Outcome
Title Patient's Assessment of Pain Intensity on a 0-100mm VAS
Hide Description The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 130 129 126
Least Squares Mean (Standard Error)
Unit of Measure: Millimeters
7.9  (1.69) 8.2  (1.7) 14.8  (1.72)
4.Secondary Outcome
Title Patient's Assessment of Pain Intensity on a 5-point Likert Scale
Hide Description A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 128
Measure Type: Number
Unit of Measure: Percentage of Patients
None 35.9 32.6 23.4
Mild 45.8 44.2 36.7
Moderate 15.3 21.7 21.9
Severe 2.3 1.6 14.1
Extreme 0.8 0 3.9
5.Secondary Outcome
Title Number of Patients With at Least One New Gouty Arthritis Flare After Baseline
Hide Description Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient’s perception. Patients 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 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 129
Measure Type: Number
Unit of Measure: Particpants
12 12 52
6.Secondary Outcome
Title Time to the First New Gouty Arthritis Flare
Hide Description Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient’s perception. Patients 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. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 129
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
7.Secondary Outcome
Title Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
Hide Description The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 130 129 129
Median (95% Confidence Interval)
Unit of Measure: Hours
24
(22 to 25)
25
(24 to 48)
48
(25 to 54)
8.Secondary Outcome
Title Time to Resolution of Gouty Arthritis Flare as Reported by Patient
Hide Description Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 128 129
Median (95% Confidence Interval)
Unit of Measure: Hours
142
(96 to 168)
120
(96 to 145)
170
(144 to 216)
9.Secondary Outcome
Title Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
Hide Description A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 129
Measure Type: Number
Unit of Measure: Percentage of Participants
Excellent 36.0 34.8 20.4
Good 43.2 36.5 31.9
Acceptable 10.4 20.0 21.2
Slight 6.4 7.8 14.2
Poor 4.0 0.9 12.4
10.Secondary Outcome
Title Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
Hide Description A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 129
Measure Type: Number
Unit of Measure: Percentage of Participants
Very good 46.2 33.6 21.5
Good 35.4 48.8 33.9
Fair 15.4 16.0 23.1
Poor 1.5 1.6 14.0
Very poor 1.5 0.0 7.4
11.Secondary Outcome
Title Physician's Assessment of Tenderness
Hide Description The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that “there is pain”, 2 = patient states “there is pain and winces” and 3 = patient states “there is pain, winces and withdraws” on palpation or passive movement of the affected study joint.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 129
Measure Type: Number
Unit of Measure: Percentage of Participants
No pain 50.0 40.0 29.8
There is pain 43.1 52.8 47.1
There is pain and winces 5.4 6.4 14.0
There is pain, winces and withdraws 1.5 0.8 9.1
12.Secondary Outcome
Title Physician's Assessment of Swelling
Hide Description The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 129
Measure Type: Number
Unit of Measure: Percentage of Partipants
No swelling 60.8 55.2 51.2
Palpable 26.9 25.6 15.7
Visible 10.8 17.6 24.8
Bulging beyond the joint margins 1.5 1.6 8.3
13.Secondary Outcome
Title Physician's Assessment of Erythema
Hide Description The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 129
Measure Type: Number
Unit of Measure: Percentage of Participants
Absent 88.3 82.9 68.6
Present 11.7 17.1 31.4
14.Secondary Outcome
Title Physician's Assessment of Range of Motion of the Most Affected Joint
Hide Description The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 129
Measure Type: Number
Unit of Measure: Percentage of Participants
Normal 50.0 44.8 35.5
Mildly restricted 37.7 40.8 37.2
Moderately restricted 11.5 12.0 14.0
Severely restricted 0.8 2.4 12.4
Immobilized 0.0 0.0 0.8
15.Secondary Outcome
Title Proportion of Patients With Rescue Medication Intake
Hide Description Patients used a diary to record the time of intake of rescue medication and the amount taken.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 129
Measure Type: Number
Unit of Measure: Percentage of Particpants
29.0 31.8 45.7
16.Secondary Outcome
Title Time to First Rescue Medication Intake
Hide Description Patients used a diary to record the time of intake of rescue medication and the amount taken.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 38 40 59
Median (Full Range)
Unit of Measure: Hours
11
(4 to 279)
7.5
(3 to 142)
11
(1 to 186)
17.Secondary Outcome
Title Amount of Rescue Medication Taken (mg)
Hide Description Patients used a diary to record the time of intake of rescue medication and the amount taken.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 131 129 129
Mean (Standard Deviation)
Unit of Measure: milligrams (mg)
Acetaminophen 609.2  (1800.06) 1108.3  (2821.54) 2323.1  (5580.82)
Codeine 12.7  (55.30) 23.9  (124.56) 60.8  (191.2)
Prednisolone / Prednisone 5.8  (23.13) 6.7  (25.09) 24.7  (53.20)
18.Secondary Outcome
Title C-reactive Protein Level
Hide Description A central laboratory was used for analysis of all blood samples collected.
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description:
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
Overall Number of Participants Analyzed 123 119 118
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg / L
3.65
(3.11 to 4.29)
3.37
(2.86 to 3.96)
5.2
(4.41 to 6.13)
Time Frame 12 weeks
Adverse Event Reporting Description Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.
 
Arm/Group Title Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Hide Arm/Group Description Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug. The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug. The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
All-Cause Mortality
Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/133 (4.51%)   6/133 (4.51%)   5/133 (3.76%) 
Cardiac disorders       
Angina unstable  1  0/133 (0.00%)  1/133 (0.75%)  0/133 (0.00%) 
Cardiac failure  1  0/133 (0.00%)  1/133 (0.75%)  0/133 (0.00%) 
Coronary artery disease  1  0/133 (0.00%)  1/133 (0.75%)  0/133 (0.00%) 
Myocardial infarction  1  0/133 (0.00%)  0/133 (0.00%)  1/133 (0.75%) 
Gastrointestinal disorders       
Constipation  1  0/133 (0.00%)  0/133 (0.00%)  1/133 (0.75%) 
General disorders       
Chest pain  1  0/133 (0.00%)  0/133 (0.00%)  1/133 (0.75%) 
Drug ineffective  1  0/133 (0.00%)  0/133 (0.00%)  1/133 (0.75%) 
Infections and infestations       
Respiratory tract infection viral  1  0/133 (0.00%)  1/133 (0.75%)  0/133 (0.00%) 
Staphylococcal bacteraemia  1  0/133 (0.00%)  1/133 (0.75%)  0/133 (0.00%) 
Viral infection  1  1/133 (0.75%)  0/133 (0.00%)  0/133 (0.00%) 
Wound infection staphylococcal  1  1/133 (0.75%)  0/133 (0.00%)  0/133 (0.00%) 
Injury, poisoning and procedural complications       
Muscle rupture  1  1/133 (0.75%)  0/133 (0.00%)  0/133 (0.00%) 
Nervous system disorders       
Migraine  1  1/133 (0.75%)  0/133 (0.00%)  0/133 (0.00%) 
Psychiatric disorders       
Delirium  1  1/133 (0.75%)  0/133 (0.00%)  0/133 (0.00%) 
Depression  1  0/133 (0.00%)  0/133 (0.00%)  1/133 (0.75%) 
Renal and urinary disorders       
Calculus ureteric  1  1/133 (0.75%)  0/133 (0.00%)  0/133 (0.00%) 
Obstructive uropathy  1  1/133 (0.75%)  0/133 (0.00%)  0/133 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/133 (0.00%)  1/133 (0.75%)  0/133 (0.00%) 
Vascular disorders       
Aortitis  1  0/133 (0.00%)  1/133 (0.75%)  0/133 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Canakinumab, Pre-filled Syringes (PFS) Canakinumab, Lyophilizate (LYO) Triamcinolone Acetonide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/133 (0.00%)   0/133 (0.00%)   0/133 (0.00%) 
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.
Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI 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 pooled data (i.e.,data from all sites) in clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01356602     History of Changes
Other Study ID Numbers: CACZ885H2361
2010-024173-39 ( EudraCT Number )
First Submitted: May 16, 2011
First Posted: May 19, 2011
Results First Submitted: September 6, 2013
Results First Posted: January 29, 2014
Last Update Posted: January 29, 2014