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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01356602
• Collaborator: (none)
• Enrollment: 397
• Locations: 99
• Arms: 3
• Duration (Months): 16.1
• Patients Per Site: 4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

Condition or Disease	Intervention/Treatment	Phase
Acute Gouty Arthritis	Drug: Canakinumab pre-filled syringe; Drug: Canakinumab lyophilized powder; Drug: Triamcinolone Acetonide; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 397 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Canakinumab, pre-filled syringes (PFS) 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.	Drug: Canakinumab pre-filled syringe; Canakinumab pre-filled syringe; Drug: Placebo; Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide
Active Comparator: Canakinumab, lyophilizate (LYO) The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.	Drug: Canakinumab lyophilized powder; Canakinumab lyophilized powder; Drug: Placebo; Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide
Active Comparator: Triamcinolone Acetonide 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.	Drug: Triamcinolone Acetonide; Triamcinolone Acetonide; Drug: Placebo; Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide

Outcome Measures

Primary Outcome Measures

1. Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups [72 hours post dose]

   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.

Secondary Outcome Measures

1. Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups [72 hours post dose]

   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.

2. Patient's Assessment of Pain Intensity on a 0-100mm VAS [14 days]

   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.

3. Patient's Assessment of Pain Intensity on a 5-point Likert Scale [72 hours]

   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.

4. Number of Patients With at Least One New Gouty Arthritis Flare After Baseline [12 weeks]

   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.

5. Time to the First New Gouty Arthritis Flare [12 weeks]

   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.

6. Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS [14 days]

   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.

7. Time to Resolution of Gouty Arthritis Flare as Reported by Patient [14 days]

   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.

8. Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale [72 hours]

   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.

9. Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale [72 hours]

   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).

10. Physician's Assessment of Tenderness [72 hours]

    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.

11. Physician's Assessment of Swelling [72 hours]

    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.

12. Physician's Assessment of Erythema [72 hours]

    The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.

13. Physician's Assessment of Range of Motion of the Most Affected Joint [72 hours]

    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).

14. Proportion of Patients With Rescue Medication Intake [12 weeks]

    Patients used a diary to record the time of intake of rescue medication and the amount taken.

15. Time to First Rescue Medication Intake [14 days]

    Patients used a diary to record the time of intake of rescue medication and the amount taken.

16. Amount of Rescue Medication Taken (mg) [14 days]

    Patients used a diary to record the time of intake of rescue medication and the amount taken.

17. C-reactive Protein Level [72 hours]

    A central laboratory was used for analysis of all blood samples collected.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• 3 or more gout flares within last year

• Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine

• Body mass index of less than or equal to 45 kg/m2

Exclusion criteria:

• Use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine.

• Hemodialysis

• Live vaccine within 3 months before first dose

• Donation or loss of 400 mL or more within 3 months before first dose

• Gout brought on by other factors such as chemotherapy, lead, transplant, etc.

• Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis

• Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions

• Significant cardiovascular conditions such as uncontrolled hypertension

• Significant medical diseases such as uncontrolled diabetes, thyroid disease

• History of malignancy of any organ system within the past 5 years

• Women who are pregnant or nursing

• Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Anniston	Alabama	United States	36207-5710
2	Novartis Investigative Site	Gulf Shores	Alabama	United States	36547
3	Novartis Investigative Site	Mobile	Alabama	United States	36608
4	Novartis Investigative Site	Chandler	Arizona	United States	85224
5	Novartis Investigative Site	Phoenix	Arizona	United States	85013
6	Novartis Investigative Site	Scottsdale	Arizona	United States	85251
7	Novartis Investigative Site	Buena Park	California	United States	90620
8	Novartis Investigative Site	Fair Oaks	California	United States	95628
9	Novartis Investigative Site	Norwalk	California	United States	90650
10	Novartis Investigative Site	Orangevale	California	United States	95662
11	Novartis Investigative Site	Pasadena	California	United States	91105
12	Novartis Investigative Site	Westlake Village	California	United States	91361
13	Novartis Investigative Site	Clearwater	Florida	United States	33756
14	Novartis Investigative Site	Jupiter	Florida	United States	33458
15	Novartis Investigative Site	Largo	Florida	United States	33773
16	Novartis Investigative Site	South Miami	Florida	United States	33143
17	Novartis Investigative Site	Augusta	Georgia	United States	30904
18	Novartis Investigative Site	Decatur	Georgia	United States	30035
19	Novartis Investigative Site	Meridian	Idaho	United States	83642
20	Novartis Investigative Site	Overland Park	Kansas	United States	66215
21	Novartis Investigative Site	Topeka	Kansas	United States	66606
22	Novartis Investigative Site	Louisville	Kentucky	United States	40217
23	Novartis Investigative Site	Owensboro	Kentucky	United States	42303
24	Novartis Investigative Site	Metairie	Louisiana	United States	70006
25	Novartis Investigative Site	Troy	Michigan	United States	48085
26	Novartis Investigative Site	Belzoni	Mississippi	United States	39038
27	Novartis Investigative Site	Jackson	Mississippi	United States	39202
28	Novartis Investigative Site	Jackson	Mississippi	United States	39209
29	Novartis Investigative Site	Picayune	Mississippi	United States	39466
30	Novartis Investigative Site	Missoula	Montana	United States	59804
31	Novartis Investigative Site	Lincoln	Nebraska	United States	68516
32	Novartis Investigative Site	Omaha	Nebraska	United States	68114
33	Novartis Investigative Site	Omaha	Nebraska	United States	68134
34	Novartis Investigative Site	Freehold	New Jersey	United States	07728
35	Novartis Investigative Site	Mineola	New York	United States	11501
36	Novartis Investigative Site	New Hyde Park	New York	United States	11042
37	Novartis Investigative Site	Roslyn	New York	United States	11576
38	Novartis Investigative Site	Asheville	North Carolina	United States	28801
39	Novartis Investigative Site	Cary	North Carolina	United States	27518
40	Novartis Investigative Site	Charlotte	North Carolina	United States	28209
41	Novartis Investigative Site	Charlotte	North Carolina	United States	28277
42	Novartis Investigative Site	Greensboro	North Carolina	United States	27401
43	Novartis Investigative Site	Greensboro	North Carolina	United States	27408
44	Novartis Investigative Site	Salisbury	North Carolina	United States	28144
45	Novartis Investigative Site	Shelby	North Carolina	United States	28152
46	Novartis Investigative Site	Wilmington	North Carolina	United States	28401
47	Novartis Investigative Site	Fargo	North Dakota	United States	58103
48	Novartis Investigative Site	Mogadore	Ohio	United States	44260
49	Novartis Investigative Site	Oklahoma City	Oklahoma	United States	73109
50	Novartis Investigative Site	Duncansville	Pennsylvania	United States	16635
51	Novartis Investigative Site	Charleston	South Carolina	United States	29412
52	Novartis Investigative Site	Columbia	South Carolina	United States	29204
53	Novartis Investigative Site	Greer	South Carolina	United States	29651
54	Novartis Investigative Site	Murrells Inlet	South Carolina	United States	29576
55	Novartis Investigative Site	Ninety Six	South Carolina	United States	29666
56	Novartis Investigative Site	Varnville	South Carolina	United States	29944
57	Novartis Investigative Site	Bristol	Tennessee	United States	37620
58	Novartis Investigative Site	Fayetteville	Tennessee	United States	33734
59	Novartis Investigative Site	Johnson City	Tennessee	United States	37601
60	Novartis Investigative Site	Memphis	Tennessee	United States	38125
61	Novartis Investigative Site	Bedford	Texas	United States	76021
62	Novartis Investigative Site	Dallas	Texas	United States	75231
63	Novartis Investigative Site	Houston	Texas	United States	77034
64	Novartis Investigative Site	Bountiful	Utah	United States	84010
65	Novartis Investigative Site	Charlottesville	Virginia	United States	22911
66	Novartis Investigative Site	Danville	Virginia	United States	24541
67	Novartis Investigative Site	Midlothian	Virginia	United States	23114
68	Novartis Investigative Site	Newport News	Virginia	United States	23606
69	Novartis Investigative Site	Bellevue	Washington	United States	98004
70	Novartis Investigative Site	St-John's	Newfoundland and Labrador	Canada	A1E 2C2
71	Novartis Investigative Site	St. John	Newfoundland and Labrador	Canada	A1B 5E8
72	Novartis Investigative Site	Toronto	Ontario	Canada	M9W 4L6
73	Novartis Investigative Site	Sainte-Foy	Quebec	Canada	G1v 3M7
74	Novartis Investigative Site	Saskatoon	Saskatchewan	Canada	S7K 0H6
75	Novartis Investigative Site	Bad Doberan		Germany	18209
76	Novartis Investigative Site	Bayreuth		Germany	95445
77	Novartis Investigative Site	Berlin		Germany	13125
78	Novartis Investigative Site	Loehne		Germany	32584
79	Novartis Investigative Site	Magdeburg		Germany	39110
80	Novartis Investigative Site	Messkirch		Germany	88605
81	Novartis Investigative Site	Regensburg		Germany	93053
82	Novartis Investigative Site	Weener		Germany	26826
83	Novartis Investigative Site	Zwiesel		Germany	94227
84	Novartis Investigative Site	Bekescsaba		Hungary	H-5600
85	Novartis Investigative Site	Budapest		Hungary	1023
86	Novartis Investigative Site	Budapest		Hungary	1027
87	Novartis Investigative Site	Debrecen		Hungary	4032
88	Novartis Investigative Site	Eger		Hungary	3300
89	Novartis Investigative Site	Gyula		Hungary	5703
90	Novartis Investigative Site	Kistarcsa		Hungary	2143
91	Novartis Investigative Site	Szikszo		Hungary	3800
92	Novartis Investigative Site	Szolnok		Hungary	5000
93	Novartis Investigative Site	Veszprem		Hungary	H-8200
94	Novartis Investigative Site	Kaunas	LT	Lithuania	50128
95	Novartis Investigative Site	Kaunas	LT	Lithuania	51349
96	Novartis Investigative Site	Vilnius	LT	Lithuania	01117
97	Novartis Investigative Site	Klaipeda		Lithuania	92288
98	Novartis Investigative Site	Vilnius		Lithuania	09020
99	Novartis Investigative Site	Vilnius		Lithuania	LT-08661

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01356602
• Other Study ID Numbers: CACZ885H2361; 2010-024173-39
• First Posted: May 19, 2011
• Last Update Posted: Jan 29, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Novartis Pharmaceuticals: Gout; arthritis; gout flare; acute gout; gouty; rheumatic disease; uric acid
• Additional relevant MeSH terms: Arthritis; Arthritis, Gouty; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Antibodies, Monoclonal; Triamcinolone diacetate

Study Results

Participant Flow

Pre-assignment Detail	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
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	133	133
Full Analysis Set	131	129	129
COMPLETED	124	117	108
NOT COMPLETED	9	15	24

Baseline Characteristics

Arm/Group Title	Canakinumab, Pre-filled Syringes (PFS)	Canakinumab, Lyophilizate (LYO)	Triamcinolone Acetonide	Total
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 Participants	133	133	133	399
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	53.4 (11.21)	53 (11.84)	53.7 (11.33)	53.5 (11.44)
Sex: Female, Male (Count of 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%

Outcome Measures

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
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

Outcome Measure Data

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
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.
Measure Participants	130	0	126
Least Squares Mean (Standard Error) [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
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

Outcome Measure Data

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
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.
Measure Participants	130	129	0
Least Squares Mean (Standard Error) [Millimeters]	17.1 (2.04)	19.7 (2.05)

3. Secondary Outcome

Title	Patient's Assessment of Pain Intensity on a 0-100mm VAS
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

Outcome Measure Data

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
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.
Measure Participants	130	129	126
Least Squares Mean (Standard Error) [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
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

Outcome Measure Data

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
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.
Measure Participants	131	129	128
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
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

Outcome Measure Data

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
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.
Measure Participants	131	129	129
Number [Particpants]	12	12	52

6. Secondary Outcome

Title	Time to the First New Gouty Arthritis Flare
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

Outcome Measure Data

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
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.
Measure Participants	131	129	129
Median (95% Confidence Interval) [Days]	NA	NA	NA

7. Secondary Outcome

Title	Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
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

Outcome Measure Data

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
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.
Measure Participants	130	129	129
Median (95% Confidence Interval) [Hours]	24	25	48

8. Secondary Outcome

Title	Time to Resolution of Gouty Arthritis Flare as Reported by Patient
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

Outcome Measure Data

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
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.
Measure Participants	131	128	129
Median (95% Confidence Interval) [Hours]	142	120	170

9. Secondary Outcome

Title	Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
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

Outcome Measure Data

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
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.
Measure Participants	131	129	129
Excellent	36.0 27.1%	34.8 26.2%	20.4 15.3%
Good	43.2 32.5%	36.5 27.4%	31.9 24%
Acceptable	10.4 7.8%	20.0 15%	21.2 15.9%
Slight	6.4 4.8%	7.8 5.9%	14.2 10.7%
Poor	4.0 3%	0.9 0.7%	12.4 9.3%

10. Secondary Outcome

Title	Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
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

Outcome Measure Data

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
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.
Measure Participants	131	129	129
Very good	46.2 34.7%	33.6 25.3%	21.5 16.2%
Good	35.4 26.6%	48.8 36.7%	33.9 25.5%
Fair	15.4 11.6%	16.0 12%	23.1 17.4%
Poor	1.5 1.1%	1.6 1.2%	14.0 10.5%
Very poor	1.5 1.1%	0.0 0%	7.4 5.6%

11. Secondary Outcome

Title	Physician's Assessment of Tenderness
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

Outcome Measure Data

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
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.
Measure Participants	131	129	129
No pain	50.0 37.6%	40.0 30.1%	29.8 22.4%
There is pain	43.1 32.4%	52.8 39.7%	47.1 35.4%
There is pain and winces	5.4 4.1%	6.4 4.8%	14.0 10.5%
There is pain, winces and withdraws	1.5 1.1%	0.8 0.6%	9.1 6.8%

12. Secondary Outcome

Title	Physician's Assessment of Swelling
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

Outcome Measure Data

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
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.
Measure Participants	131	129	129
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
Description	The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.
Time Frame	72 hours

Outcome Measure Data

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
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.
Measure Participants	131	129	129
Absent	88.3 66.4%	82.9 62.3%	68.6 51.6%
Present	11.7 8.8%	17.1 12.9%	31.4 23.6%

14. Secondary Outcome

Title	Physician's Assessment of Range of Motion of the Most Affected Joint
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

Outcome Measure Data

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
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.
Measure Participants	131	129	129
Normal	50.0 37.6%	44.8 33.7%	35.5 26.7%
Mildly restricted	37.7 28.3%	40.8 30.7%	37.2 28%
Moderately restricted	11.5 8.6%	12.0 9%	14.0 10.5%
Severely restricted	0.8 0.6%	2.4 1.8%	12.4 9.3%
Immobilized	0.0 0%	0.0 0%	0.8 0.6%

15. Secondary Outcome

Title	Proportion of Patients With Rescue Medication Intake
Description	Patients used a diary to record the time of intake of rescue medication and the amount taken.
Time Frame	12 weeks

Outcome Measure Data

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
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.
Measure Participants	131	129	129
Number [Percentage of Particpants]	29.0	31.8	45.7

16. Secondary Outcome

Title	Time to First Rescue Medication Intake
Description	Patients used a diary to record the time of intake of rescue medication and the amount taken.
Time Frame	14 days

Outcome Measure Data

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
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.
Measure Participants	38	40	59
Median (Full Range) [Hours]	11 (61.87)	7.5 (31.59)	11 (39.06)

17. Secondary Outcome

Title	Amount of Rescue Medication Taken (mg)
Description	Patients used a diary to record the time of intake of rescue medication and the amount taken.
Time Frame	14 days

Outcome Measure Data

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
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.
Measure Participants	131	129	129
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
Description	A central laboratory was used for analysis of all blood samples collected.
Time Frame	72 hours

Outcome Measure Data

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
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.
Measure Participants	123	119	118
Least Squares Mean (95% Confidence Interval) [mg / L]	3.65	3.37	5.2

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Canakinumab, Pre-filled Syringes (PFS)		Canakinumab, Lyophilizate (LYO)		Triamcinolone Acetonide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/133 (4.5%)		6/133 (4.5%)		5/133 (3.8%)
Cardiac disorders
Angina unstable	0/133 (0%)		1/133 (0.8%)		0/133 (0%)
Cardiac failure	0/133 (0%)		1/133 (0.8%)		0/133 (0%)
Coronary artery disease	0/133 (0%)		1/133 (0.8%)		0/133 (0%)
Myocardial infarction	0/133 (0%)		0/133 (0%)		1/133 (0.8%)
Gastrointestinal disorders
Constipation	0/133 (0%)		0/133 (0%)		1/133 (0.8%)
General disorders
Chest pain	0/133 (0%)		0/133 (0%)		1/133 (0.8%)
Drug ineffective	0/133 (0%)		0/133 (0%)		1/133 (0.8%)
Infections and infestations
Respiratory tract infection viral	0/133 (0%)		1/133 (0.8%)		0/133 (0%)
Staphylococcal bacteraemia	0/133 (0%)		1/133 (0.8%)		0/133 (0%)
Viral infection	1/133 (0.8%)		0/133 (0%)		0/133 (0%)
Wound infection staphylococcal	1/133 (0.8%)		0/133 (0%)		0/133 (0%)
Injury, poisoning and procedural complications
Muscle rupture	1/133 (0.8%)		0/133 (0%)		0/133 (0%)
Nervous system disorders
Migraine	1/133 (0.8%)		0/133 (0%)		0/133 (0%)
Psychiatric disorders
Delirium	1/133 (0.8%)		0/133 (0%)		0/133 (0%)
Depression	0/133 (0%)		0/133 (0%)		1/133 (0.8%)
Renal and urinary disorders
Calculus ureteric	1/133 (0.8%)		0/133 (0%)		0/133 (0%)
Obstructive uropathy	1/133 (0.8%)		0/133 (0%)		0/133 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/133 (0%)		1/133 (0.8%)		0/133 (0%)
Vascular disorders
Aortitis	0/133 (0%)		1/133 (0.8%)		0/133 (0%)
Other (Not Including Serious) Adverse Events
	Canakinumab, Pre-filled Syringes (PFS)		Canakinumab, Lyophilizate (LYO)		Triamcinolone Acetonide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/133 (0%)		0/133 (0%)		0/133 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.