ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00424346
Recruitment Status : Completed
First Posted : January 19, 2007
Results First Posted : June 19, 2013
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Canakinumab
Drug: Placebo
Enrollment 274
Recruitment Details 277 patients were randomized in core (CACZ885A2201): 71 were assigned to ACZ885 600 mg intravenous(iv) + 300 mg subcutaneous each 2 weeks(sc q2wk), 66 to ACZ885 300 mg sc q2wk, 69 to ACZ885 150 mg sc q4wk, 71 to placebo. 3 were randomized but not treated. All other 274 (98.9%) were treated and had post-baseline efficacy data.
Pre-assignment Details Enrollment in core & CACZ885A2201E2 was determined by how many entered first extension study. Study protocols did not mandate that patients continue treatment in the extension phase and furthermore the reason for not continuing from the Core to the Extension phase was not capture. A total of 6.6% completed extensions.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks. Participants in this treatment group who participated in the Extension Phase are represented in the 'Canakinumab 300 mg q2wk' treatment group in the Extension Phase table below. Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Period Title: Core Study
Started 71 64 69 70
Completed 62 56 65 63
Not Completed 9 8 4 7
Reason Not Completed
Adverse Event             5             3             1             1
Abnormal Laboratory Values             0             1             0             0
Lack of Efficacy             1             3             0             4
Withdrawal by Subject             1             0             0             2
Lost to Follow-up             1             1             0             0
Administrative Problems             1             0             1             0
Protocol Violation             0             0             2             0
Period Title: Extension Phase
Started 0 [1] 110 [2] 59 58
Completed 0 8 4 3
Not Completed 0 102 55 55
Reason Not Completed
Adverse Event             0             9             5             4
Lack of Efficacy             0             16             14             11
Withdrawal by Subject             0             5             3             4
Lost to Follow-up             0             2             0             0
Administrative Problems             0             69             32             35
Death             0             0             0             1
Protocol Violation             0             1             1             0
[1]
Participants are represented in the Canakinumab 300 mg q2wk treatment group.
[2]
Includes participants who completed the Core phase in the Canakinumab 600 mg IV + 300 mg q2wk group.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo Total
Hide Arm/Group Description Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks. Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 71 64 69 70 274
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 64 participants 69 participants 70 participants 274 participants
≥18 - <41 years 5 5 7 7 24
≥41 - <65 years 50 31 43 43 167
≥65 - <75 years 11 18 16 16 61
≥75 years 5 10 3 4 22
[1]
Measure Description: Demographics for the Core Study population. The number of patients in the core phase was 274.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 64 participants 69 participants 70 participants 274 participants
≥18 - <41 years NA [2]  7 6 6 19
≥41 - <65 years NA [2]  66 39 38 143
≥65 - <75 years NA [2]  25 12 12 49
≥75 years NA [2]  12 2 2 16
[1]
Measure Description: Demographics for the Extension study population. The number of participants in the optional extension phase was less than the overall number of baseline participants who started the study. Total number of patients is 227.
[2]
This group did not exist in the extension studies, only in core.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 64 participants 69 participants 70 participants 274 participants
Female
60
  84.5%
57
  89.1%
56
  81.2%
52
  74.3%
225
  82.1%
Male
11
  15.5%
7
  10.9%
13
  18.8%
18
  25.7%
49
  17.9%
[1]
Measure Description: Demographics for the Core Study population.
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 71 participants 64 participants 69 participants 70 participants 274 participants
Female 0 94 47 44 185
Male 0 16 12 14 42
[1]
Measure Description: Demographics for the Extension study population. The number of patients in the optional extension phase was less than the overall number of baseline participants who started the study. Total number of patients is 227.
1.Primary Outcome
Title Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Week 12
Hide Description

Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:

  • Patient’s pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);
  • Patient’s global assessment of disease activity (VAS 100 mm);
  • Physician’s global assessment of disease activity (VAS 100 mm);
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);
  • Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).

Details on each of these components are provided in Outcome Measures 10-16. Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders.

Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all patients as randomized that received at least one dose of study drug and had at least one post-baseline efficacy assessment. The number of patients in the analysis includes those with ACR50 evaluation. Last observation carried forward was applied for all the component variables.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 68 70
Measure Type: Number
Unit of Measure: percentage of participants
9.9 23.4 26.5 11.4
2.Primary Outcome
Title Percentage of American College of Rheumatology [ACR] 20 Criteria Responders During the Extension Phase
Hide Description

Participants were defined as ACR20 responders if they had at least a 20% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:

  • Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])
  • Patient's global assessment of disease activity (VAS 100 mm)
  • Physician's global assessment of disease activity (VAS 100 mm)
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
  • Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).

Participants were considered as non-responders if they failed the ACR20 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders.

Time Frame Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR20 evaluation data available.
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 110 59 58
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 [N=105, 57, 56] 52.4 64.9 66.1
Week 36 [N=100, 48, 49] 57.0 66.7 63.3
Week 48 [N=95, 43, 47] 66.3 81.4 72.3
Week 60 [N=87, 40, 42] 60.9 75.0 73.8
Week 72 [N=66, 34, 27] 62.1 76.5 74.1
Week 88 [N=43, 25, 23] 67.4 72.0 82.6
Week 100 [N=21, 12, 14] 81.0 75.0 91.7
Week 112 [N=13, 8, 6] 76.9 75.0 66.7
Week 124 [N=2, 1, 1] 100.0 100.0 100.0
End of Study Visit [N=103, 53, 54] 51.5 54.7 61.1
3.Primary Outcome
Title Percentage of American College of Rheumatology [ACR] 50 Criteria Responders During the Extension Phase
Hide Description

Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:

  • Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])
  • Patient's global assessment of disease activity (VAS 100 mm)
  • Physician's global assessment of disease activity (VAS 100 mm)
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
  • Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).

Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders.

Time Frame Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR50 evaluation data available.
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 110 59 58
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 [N=106, 57, 56] 18.9 29.8 37.5
Week 36 [N=100, 48, 49] 24.0 31.3 32.7
Week 48 [N=95, 43, 47] 34.7 48.8 34.0
Week 60 [N=87, 40, 42] 34.5 42.5 42.9
Week 72 [N=66, 34, 27] 37.9 58.8 48.1
Week 88 [N=43, 25, 23] 39.5 44.0 52.2
Week 100 [N=21, 13, 14] 47.6 30.8 57.1
Week 112 [N=13, 8, 6] 23.1 62.5 66.7
Week 124 [N=2, 1, 1] 50.0 100.0 100.0
End of Study Visit [N=103, 53, 54] 23.3 35.8 35.2
4.Primary Outcome
Title Percentage of American College of Rheumatology [ACR] 70 Criteria Responders During the Extension Phase
Hide Description

Participants were defined as ACR70 responders if they had at least a 70% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:

  • Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS])
  • Patient's global assessment of disease activity (VAS 100 mm)
  • Physician's global assessment of disease activity (VAS 100 mm)
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score)
  • Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).

Participants were considered as non-responders if they failed the ACR70 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders.

Time Frame Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. The number of patients in the analysis at each time point (N) includes those with ACR70 evaluation data available.
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 110 59 58
Measure Type: Number
Unit of Measure: percentage of participants
Week 24 [N=106, 57, 56] 5.7 10.5 14.3
Week 36 [N=100, 48, 49] 7.0 4.2 12.2
Week 48 [N=96, 43, 47] 10.4 9.3 6.4
Week 60 [N=87, 40, 42] 16.1 17.5 19.0
Week 72 [N=66, 34, 27] 15.2 20.6 14.8
Week 88 [N=44, 25, 23] 15.9 16.0 17.4
Week 100 [N=21, 14, 14] 14.3 21.4 28.6
Week 112 [N=13, 8, 6] 7.7 37.5 33.3
Week 124 [N=2, 1, 1] 50.0 100.0 0.0
End of Study Visit [N=103, 54, 54] 13.6 16.7 13.0
5.Primary Outcome
Title Change From Baseline in Disease Activity Score (DAS) 28 During the Extension Phase
Hide Description

The Disease Activity Score (DAS) 28 is a combined index to measure the disease activity in patients with rheumatoid arthritis, and includes the following variables:

  • The number of swollen and tender joints assessed using the 28-joint count;
  • C-reactive protein (CRP) in mg/L;
  • Patient's global assessment of disease activity measured on a 100 mm visual analog scale.

The DAS28 score ranges from zero to ten. DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6

Time Frame Baseline and Weeks 24, 72 and 112
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study intent-to-treat (ITT) population consisted of all patients who entered the extension study and who received at least one dose of study drug in the extension studies. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 110 59 58
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 24 [N=103, 56, 54] -1.60  (1.171) -1.82  (1.333) -1.93  (1.474)
Week 72 [N=63, 31, 26] -2.18  (1.302) -2.58  (1.232) -2.21  (1.132)
Week 112 [N=13, 8, 6] -2.00  (1.110) -2.73  (1.252) -2.59  (1.916)
End of Study Visit [N=100, 52, 49} -1.83  (1.434) -1.79  (1.551) -1.86  (1.621)
6.Secondary Outcome
Title Percentage of American College of Rheumatology [ACR] 50 Criteria Responders at Weeks 2, 4 and 8
Hide Description

Participants were defined as ACR50 responders if they had at least a 50% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:

  • Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);
  • Patient's global assessment of disease activity (VAS 100 mm);
  • Physician's global assessment of disease activity (VAS 100 mm);
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);
  • Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).

Participants were considered as non-responders if they failed the ACR50 criteria. Participants who prematurely discontinued due to insufficient therapeutic effect were also considered non-responders.

Time Frame Baseline and Weeks 2, 4 and 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR50 evaluation. Last observation carried forward was applied for all the component variables. "N" indicates the number of patients included at each time point.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Measure Type: Number
Unit of Measure: percentage of participants
Responders at Week 2 [N=70, 64, 69, 70] 2.9 1.6 5.8 4.3
Responders at Week 4 [N=71, 64, 69, 70] 1.4 7.8 7.2 4.3
Responders at Week 8 [N=71, 64, 69, 70] 4.2 17.2 17.4 7.1
7.Secondary Outcome
Title Percentage of American College of Rheumatology [ACR] 20 Criteria Responders
Hide Description

Participants were defined as ACR20 responders if they had at least a 20% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:

  • Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);
  • Patient's global assessment of disease activity (VAS 100 mm);
  • Physician's global assessment of disease activity (VAS 100 mm);
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);
  • Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).

Participants were considered ACR20 non-responders if they failed the ACR20 criteria. Patients who prematurely discontinued the study due to insufficient therapeutic effect were also considered non responders.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR20 evaluation. Last observation carried forward was applied for all the component variables. "N" indicates the number of patients included at each time point.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Measure Type: Number
Unit of Measure: percentage of participants
Responders at Week 2 [N=70, 64, 69, 70] 17.1 29.7 23.2 14.3
Responders at Week 4 [N=71, 64, 68, 70] 29.6 37.5 39.7 20.0
Responders at Week 8 [N=71, 64, 68, 70] 35.2 43.8 42.6 27.1
Responders at Week 12 [N=71, 64, 68, 70] 43.7 48.4 50.0 28.6
8.Secondary Outcome
Title Percentage of American College of Rheumatology [ACR] 70 Criteria Responders
Hide Description

Participants were defined as ACR70 responders if they had at least a 70% improvement from Baseline in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:

  • Patient's pain assessment (assessed using a 100 mm Visual Analog Scale [VAS]);
  • Patient's global assessment of disease activity (VAS 100 mm);
  • Physician's global assessment of disease activity (VAS 100 mm);
  • Patient self-assessed disability (Health Assessment Questionnaire (HAQ) score);
  • Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).

Participants were considered ACR70 non-responders if they failed the ACR70 criteria. Patients who prematurely discontinued the study due to insufficient therapeutic effect were also considered non responders.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR70 evaluation. Last observation carried forward was applied for all the component variables. "N" indicates the number of patients included at each time point.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Measure Type: Number
Unit of Measure: percentage of participants
Responders at Week 2 [N=70, 64, 69, 70] 0.0 1.6 0.0 0.0
Responders at Week 4 [N=71, 64, 69, 70] 0.0 1.6 4.3 0.0
Responders at Week 8 [N=71, 64, 69, 70] 0.0 4.7 5.8 2.9
Responders at Week 12 [N=71, 64, 69, 70] 4.2 3.1 5.8 2.9
9.Secondary Outcome
Title Number of Distinct Responders According to ACR20, ACR50 and ACR70 Criteria at Week 12
Hide Description

To assess differences between the level of clinical response attained and not just whether the patient did or did not achieve a particular level of response, participants were categorized as follows:

  1. Did not attain an ACR20 response;
  2. Attained a 20% but not a 50% response;
  3. Attained a 50% but not a 70% response;
  4. Attained a 70% or greater response.

A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if they had at least a 20, 50 or 70% improvement from Baseline, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:

  • Patient’s pain assessment (100 mm visual analog scale [VAS]);
  • Patient’s global assessment of disease activity (VAS 100 mm);
  • Physician’s global assessment of disease activity (VAS 100 mm);
  • Patient self-assessed disability (Health Assessment Questionnaire [HAQ] score);
  • Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).
Time Frame Baseline and Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population. The number of patients in the analysis includes those with ACR evaluation. Last observation carried forward was applied for all the component variables.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 68 70
Measure Type: Number
Unit of Measure: participants
No response 40 33 34 50
ACR20 - not ACR50 response 24 16 16 12
ACR50 - not ACR70 response 4 13 14 6
ACR70 response 3 2 4 2
10.Secondary Outcome
Title Change From Baseline in Swollen 28-joint Count
Hide Description

The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).

Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, the number of patients included in the analysis at each time point is indicated by "N". Last observation carried forward was utilized.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Least Squares Mean (Standard Error)
Unit of Measure: swollen joints
Week 2 [N=70, 64, 69, 70] -2.4  (0.53) -2.7  (0.56) -3.1  (0.54) -2.3  (0.54)
Week 4 [N=71, 64, 69, 70] -3.4  (0.55) -4.0  (0.58) -4.6  (0.56) -3.0  (0.56)
Week 8 [N=71, 64, 69, 70] -4.0  (0.58) -4.4  (0.61) -4.9  (0.59) -3.3  (0.59)
Week 12 [N=71, 64, 69, 70] -4.6  (0.64) -5.3  (0.67) -5.2  (0.65) -3.4  (0.65)
11.Secondary Outcome
Title Change From Baseline in Tender 28-joint Count
Hide Description

The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).

Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, the number of patients included in the analysis at each time point is indicated by "N". Last observation carried forward was utilized.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Least Squares Mean (Standard Error)
Unit of Measure: tender joints
Week 2 [N=70, 64, 69, 70] -3.0  (0.68) -2.1  (0.71) -3.6  (0.68) -3.2  (0.69)
Week 4 [N=71, 64, 69, 70] -4.1  (0.77) -4.0  (0.80) -5.0  (0.78) -4.2  (0.78)
Week 8 [N=71, 64, 69, 70] -4.6  (0.79) -4.7  (0.83) -5.4  (0.80) -4.7  (0.80)
Week 12 [N=71, 64, 69, 70] -4.3  (0.86) -4.8  (0.90) -6.3  (0.87) -4.5  (0.87)
12.Secondary Outcome
Title Change From Baseline in Patient’s Pain Intensity
Hide Description

The patient’s assessment of pain was performed using a 100 mm visual analog scale (VAS) ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.

Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 68 70
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 [N=70, 64, 68, 70] -6.7  (2.20) -8.0  (2.29) -8.3  (2.23) -4.2  (2.22)
Week 4 [N=71, 64, 68, 70] -9.1  (2.40) -9.6  (2.52) -11.4  (2.45) -5.6  (2.45)
Week 8 [N=71, 64, 68, 70] -12.2  (2.66) -12.5  (2.80) -14.0  (2.72) -7.6  (2.72)
Week 12 [N=71, 64, 68, 70] -14.2  (2.72) -15.1  (2.87) -17.0  (2.78) -10.5  (2.78)
13.Secondary Outcome
Title Change From Baseline in Patient’s Global Assessment of Disease Activity
Hide Description

The patient’s global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100), after the question "Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing”. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.

Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 68 70
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 [N=70, 64, 68, 70] -6.4  (2.12) -7.5  (2.21) -7.9  (2.15) -5.0  (2.15)
Week 4 [N= 71, 64, 68, 70] -9.4  (2.28) -11.2  (2.39) -12.8  (2.33) -6.1  (2.33)
Week 8 [N= 71, 64, 68, 70] -13.9  (2.63) -15.7  (2.76) -13.8  (2.68) -6.9  (2.68)
Week 12 [N= 71, 64, 68, 70] -14.5  (2.61) -17.5  (2.74) -17.6  (2.66) -10.1  (2.66)
14.Secondary Outcome
Title Change From Baseline in Physician’s Global Assessment of Disease Activity
Hide Description

The physician’s global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100). To enhance objectivity, the physician was not aware of the specific patient’s global assessment of disease activity when performing their own assessment on that patient. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.

Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 68 70
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 [N=70, 64, 68, 69] -13.3  (2.21) -14.8  (2.34) -15.2  (2.25) -9.3  (2.25)
Week 4 [N=71, 64, 68, 70] -17.7  (2.40) -20.1  (2.55) -20.3  (2.46) -12.2  (2.45)
Week 8 [N=71, 64, 68, 70] -20.8  (2.68) -22.6  (2.86) -23.6  (2.75) -16.5  (2.74)
Week 12 [N=71, 64, 68, 70] -21.6  (2.82) -24.0  (3.01) -26.4  (2.90) -17.6  (2.88)
15.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire (HAQ) Score
Hide Description

The patient health assessment questionnaire (HAQ) was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories, ranging from ‘without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from Baseline score indicates improvement in disability status.

Least squares means (LSM) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by "N". Last observation carried forward was utilized.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 [N=70, 64, 69, 70] -0.1  (0.04) 0.0  (0.05) -0.1  (0.04) -0.1  (0.04)
Week 4 [N=71, 64, 69, 70] -0.1  (0.05) -0.1  (0.05) -0.2  (0.05) -0.1  (0.05)
Week 8 [N=71, 64, 69, 70] -0.2  (0.06) -0.1  (0.06) -0.2  (0.06) -0.1  (0.06)
Week 12 [N=71, 64, 69, 70] -0.2  (0.06) -0.2  (0.06) -0.2  (0.06) -0.1  (0.06)
16.Secondary Outcome
Title Change From Baseline in High-sensitive C-Reactive Protein (hsCRP) Levels
Hide Description

HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.

Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline value as a covariate.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by "N". Last observation carried forward was utilized.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Least Squares Mean (Standard Error)
Unit of Measure: mg/L
Week 2 [N=69, 64, 67, 70] -5.6  (1.72) -5.8  (1.79) -4.7  (1.75) -1.7  (1.74)
Week 4 [N=71, 64, 69, 70] -5.2  (1.69) -7.4  (1.78) -6.5  (1.72) -1.7  (1.73)
Week 8 [N=71, 64, 69, 70] -4.3  (1.72) -6.9  (1.82) -3.5  (1.75) 0.0  (1.77)
Week 12 [N=71, 64, 69, 70] -5.6  (1.89) -3.4  (1.99) -8.0  (1.92) -0.7  (1.94)
17.Secondary Outcome
Title Change From Baseline in Disease Activity Score (DAS) 28
Hide Description

The Disease Activity Score (DAS) 28 is a combined index to measure the disease activity in patients with rheumatoid arthritis, and includes the following variables:

  • The number of swollen and tender joints assessed using the 28-joint count;
  • C-reactive protein (CRP) in mg/L;
  • Patient's global assessment of disease activity measured on a 100 mm visual analog scale.

The DAS28 score ranges from zero to ten. DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.

Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline DAS28 value as a covariate.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by "N". Last observation carried forward was utilized.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 68 70
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 [N=69, 64, 66, 70] -0.7  (0.11) -0.7  (0.11) -0.8  (0.11) -0.5  (0.11)
Week 4 [N=71, 64, 68, 70] -0.9  (0.13) -1.0  (0.13) -1.1  (0.13) -0.7  (0.13)
Week 8 [N=71, 64, 68, 70] -1.1  (0.14) -1.2  (0.15) -1.2  (0.14) -0.8  (0.14)
Week 12 [N=71, 64, 68, 70] -1.2  (0.15) -1.3  (0.16) -1.5  (0.15) -0.9  (0.15)
18.Secondary Outcome
Title Change From Baseline in Erythrocyte Sedimentation Rate
Hide Description Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. A negative change from Baseline score indicates improvement.
Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by "N". Last observation carried forward was utilized.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Mean (Standard Deviation)
Unit of Measure: mm/hr
Week 2 [N=68, 64, 67, 69] -9.0  (12.85) -8.2  (15.97) -9.0  (12.43) -2.9  (11.62)
Week 4 [N=71, 64, 69, 70] -9.2  (15.11) -9.6  (17.43) -11.8  (14.71) -2.6  (12.94)
Week 8 [N=71, 64, 69, 70] -11.3  (16.28) -12.3  (16.02) -12.8  (13.89) -4.4  (15.65)
Week 12 [N=71, 64, 69, 70] -11.2  (18.20) -11.1  (18.12) -15.1  (14.96) -4.1  (16.73)
19.Secondary Outcome
Title Change From Baseline in Rheumatoid Factor Concentration
Hide Description Rheumatoid factor (RF) is an autoantibody (antibody directed against an organism's own tissues) that is an indicator of inflammation and rheumatoid arthritis.
Time Frame Baseline and Weeks 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by "N". Last observation carried forward was utilized.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Mean (Standard Deviation)
Unit of Measure: kIU/L
Week 4 [N=70, 62, 68, 67] -6.7  (71.53) -10.6  (99.36) -16.1  (144.18) -0.9  (85.28)
Week 8 [N=70, 63, 69, 70] -2.6  (117.30) 22.7  (134.66) -57.1  (442.24) 6.0  (91.51)
Week 12 [N=70, 64, 69, 70] 2.0  (135.70) 29.7  (144.91) -50.7  (531.68) 16.9  (110.03)
20.Secondary Outcome
Title Change From Baseline in Short Form 36 Health Survey (SF-36)
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.
Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by "N". Last observation carried forward was utilized.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical component: Week 2 [N=61, 61, 59, 64] 1.73  (5.013) 0.27  (5.648) 2.85  (4.999) 2.03  (6.996)
Physical component: Week 4 [N=65, 62, 63, 67] 2.71  (6.582) 2.30  (6.972) 3.21  (6.406) 2.43  (7.134)
Physical component: Week 8 [N=67, 62, 63, 68] 2.62  (6.528) 2.75  (7.331) 4.29  (8.757) 1.96  (7.464)
Physical component: Week 12 [N=68, 62, 63, 68] 4.03  (6.519) 3.05  (7.847) 5.73  (8.612) 2.69  (7.846)
Mental component: Week 2 [N=61, 61, 59, 64] 0.56  (8.831) 2.64  (8.425) 1.21  (8.486) 0.63  (9.234)
Mental component: Week 4 [N=65, 62, 63, 67] 2.18  (9.660) 2.75  (11.364) 2.23  (8.634) 1.75  (8.331)
Mental component: Week 8 [N=67, 62, 63, 68] 2.29  (10.505) 2.83  (11.760) 3.04  (9.307) 1.18  (9.580)
Mental component: Week 12 [N=68, 62, 63, 68] 1.44  (9.988) 3.34  (11.927) 4.06  (10.952) 0.35  (9.294)
21.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F)
Hide Description

The fatigue subscale of the FACIT is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants respond to each item on a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much) based on their experience of fatigue during the past 2 weeks. The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. FACIT Fatigue subscale scores range from 0 to 52, where higher scores represent less fatigue.

Least squares means (LSMs) were derived from an Analysis of Covariance (ANCOVA) model adjusting for treatment and center with baseline FACIT-F value as a covariate.

Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population, only patients with a value at both Baseline and post-baseline are included in the analysis. The number of patients included at each time point is indicated by "N". Last observation carried forward was utilized.
Arm/Group Title Canakinumab 600 mg IV + 300 mg q2wk Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 71 64 69 70
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Week 2 [N=62, 63, 63, 64] 2.5  (0.90) 1.6  (0.87) 3.7  (0.89) 2.5  (0.89)
Week 4 [N=66, 64, 66, 67] 3.8  (0.99) 3.3  (0.99) 4.9  (0.98) 2.1  (1.00)
Week 8 [N=67, 64, 66, 67] 4.2  (1.13) 4.0  (1.15) 4.6  (1.13) 2.1  (1.15)
Week 12 [N=67, 64, 66, 67] 4.9  (1.14) 3.8  (1.15) 5.7  (1.14) 1.4  (1.16)
22.Secondary Outcome
Title Number of Distinct Responders According to ACR20, ACR50 and ACR70 Criteria at the End of the Extension Study
Hide Description

To assess differences between the level of clinical response attained and not just whether the patient did or did not achieve a particular level of response, patients were categorized as follows:

  1. Did not attain an ACR20 response;
  2. Attained a 20% but not a 50% response;
  3. Attained a 50% but not a 70% response;
  4. Attained a 70% or greater response.

A participant was considered as improved according to the ACR20, ACR50 or ACR70 criteria if they had at least a 20, 50 or 70% improvement from Baseline, respectively, in both the tender and the swollen 28-joint count, and in at least 3 of the following 5 measures:

  • Patient's pain assessment (100 mm visual analog scale [VAS]);
  • Patient's global assessment of disease activity (VAS 100 mm);
  • Physician's global assessment of disease activity (VAS 100 mm);
  • Patient self-assessed disability (Health Assessment Questionnaire [HAQ] score);
  • Acute phase reactant (high sensitivity C-reactive Protein [hsCRP]).
Time Frame Baseline and End of Study (up to 124 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Extension Study ITT population.
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 103 53 54
Measure Type: Number
Unit of Measure: participants
No response 50 24 21
ACR20 - not ACR50 response 29 10 14
ACR50 - not ACR70 response 10 10 12
ACR70 response 14 9 7
23.Secondary Outcome
Title Change From Baseline in Swollen 28-joint Count During the Extension Study
Hide Description The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).
Time Frame Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 110 59 58
Mean (Standard Deviation)
Unit of Measure: swollen joints
Week 24 [N=105, 58, 55] -6.04  (4.892) -5.70  (5.119) -6.93  (5.300)
Week 36 [N=100, 49, 49] -7.12  (4.828) -6.79  (4.365) -7.05  (4.726)
Week 48 [N=95, 44, 47] -7.72  (4.171) -7.52  (3.622) -7.74  (4.454)
Week 60 [N=89, 40, 43] -7.69  (4.670) -7.38  (3.737) -8.65  (4.825)
Week 72 [N=66, 35, 27] -7.41  (5.311) -7.94  (4.143) -7.60  (3.678)
Week 88 [N=44, 25, 22] -8.38  (4.369) -7.24  (3.666) -7.50  (3.389)
Week 100 [N=21, 13, 14] -8.29  (4.285) -8.15  (2.824) -7.56  (2.974)
Week 112 [N=13, 8, 6] -7.39  (5.308) -9.50  (2.976) -5.83  (5.636)
Week 124 [N=2, 1, 1] -6.50  (0.707) -16.00 [1]   (NA) -4.00 [1]   (NA)
End of Study Visit [N=103, 55, 53] -6.36  (5.477) -5.99  (4.937) -6.67  (6.350)
[1]
Mean based on 1 participant. Standard deviation can not be calculated.
24.Secondary Outcome
Title Change From Baseline in Tender 28-joint Count During the Extension Study
Hide Description The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2).
Time Frame Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 105 58 55
Mean (Standard Deviation)
Unit of Measure: tender joints
Week 24 [N=105, 58, 55] -6.93  (7.078) -8.27  (7.555) -8.49  (7.298)
Week 36 [N=100, 49, 49] -7.92  (6.793) -9.83  (6.459) -8.95  (7.154)
Week 48 [N=95, 44, 47] -8.64  (7.193) -10.75  (5.948) -10.05  (6.321)
Week 60 [N=89, 40, 43] -8.52  (6.915) -11.10  (6.484) -10.76  (6.185)
Week 72 [N=66, 35, 27] -8.71  (7.556) -11.37  (7.436) -9.56  (4.722)
Week 88 [N=44, 25, 22] -10.34  (5.995) -10.76  (7.184) -9.98  (4.964)
Week 100 [N=21, 13, 14] -8.53  (5.780) -12.00  (5.307) -9.08  (4.989)
Week 112 [N=13, 8, 6] -8.47  (6.205) -13.63  (6.435) -9.17  (5.981)
Week 124 [N=2, 1, 1] -9.00  (4.243) -23.00 [1]   (NA) -8.00 [1]   (NA)
End of Study Visit [N=103, 55, 53] -7.93  (7.857) -8.43  (8.331) -8.83  (7.573)
[1]
Mean based on 1 participant. Standard deviation can not be calculated.
25.Secondary Outcome
Title Change From Baseline in Patient's Pain Intensity During the Extension Study
Hide Description The patient's assessment of pain was performed using a 100 mm visual analog scale (VAS) ranging from no pain (0) to unbearable pain (100). The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in pain intensity.
Time Frame Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 106 57 56
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 24 [N=106, 57, 56] -22.8  (26.44) -24.1  (25.69) -20.8  (25.61)
Week 36 [N=100, 48, 48] -21.7  (29.00) -28.2  (22.05) -24.0  (24.13)
Week 48 [N=96, 43, 47] -25.1  (28.08) -30.6  (21.94) -21.1  (23.02)
Week 60 [N=87, 40, 42] -26.3  (27.09) -27.8  (25.63) -30.0  (23.04)
Week 72 [N=66, 34, 27] -29.0  (27.42) -35.2  (26.06) -26.2  (27.63)
Week 88 [N=43, 25, 23] -28.5  (30.42) -29.0  (30.23) -32.3  (24.84)
Week 100 [N=21, 13, 14] -30.7  (23.60) -27.6  (26.14) -32.0  (26.15)
Week 112 [N=13, 8, 6] -33.3  (20.38) -17.5  (25.39) -31.7  (38.93)
Week 124 [N=2, 1, 1] -55.0  (15.56) -17.0 [1]   (NA) -24.0 [1]   (NA)
End of Study Visit [N=103, 53, 54] -19.1  (28.14) -21.9  (27.19) -20.9  (27.45)
[1]
Mean based on 1 participant. Standard deviation can not be calculated.
26.Secondary Outcome
Title Change From Baseline in Patient's Global Assessment of Disease Activity During the Extension Study
Hide Description The patient's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100), after the question "Considering all the ways your arthritis affects you, draw a line on the scale for how well you are doing". The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.
Time Frame Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 105 57 56
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 24 [N=105, 57, 56] -23.2  (26.12) -21.9  (23.21) -18.6  (24.42)
Week 36 [N=100, 48, 48] -22.5  (28.61) -23.8  (23.11) -20.0  (25.52)
Week 48 [N=96, 43, 47] -25.8  (27.92) -27.2  (21.44) -23.6  (25.23)
Week 60 [N=87, 40, 42] -27.7  (29.08) -24.4  (24.23) -26.5  (25.63)
Week 72 [N=66, 33, 27] -28.6  (24.54) -32.1  (26.56) -24.1  (32.14)
Week 88 [N=43, 25, 23] -28.4  (27.77) -30.9  (25.59) -29.2  (23.95)
Week 100 [N=21, 13, 14] -34.1  (20.69) -27.6  (21.85) -31.9  (24.45)
Week 112 [N=13, 8, 6] -29.9  (23.05) -28.5  (19.01) -36.8  (38.84)
Week 124 [N=2, 1, 1] -59.5  (20.51) -20.0 [1]   (NA) -21.0 [1]   (NA)
End of Study Visit [N=103, 52, 54] -20.4  (27.93) -19.7  (26.29) -18.6  (27.61)
[1]
Mean based on 1 participant. Standard deviation can not be calculated.
27.Secondary Outcome
Title Change From Baseline in Physician's Global Assessment of Disease Activity During the Extension Study
Hide Description The physician's global assessment of disease activity was performed using a 100 mm visual analog scale (VAS) ranging from no arthritis activity (0) to maximal arthritis activity (100). To enhance objectivity, the physician was not aware of the specific patient's global assessment of disease activity when performing their own assessment on that patient. The distance in mm from the left edge of the scale was measured. A negative change from Baseline score indicates improvement in assessment of disease activity.
Time Frame Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 105 57 55
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 24 [N=105, 57, 55] -30.9  (23.58) -36.1  (25.59) -36.0  (23.94)
Week 36 [N=98, 48, 48] -31.1  (22.69) -41.6  (18.24) -37.3  (24.17)
Week 48 [N=93, 43, 47] -34.3  (22.60) -45.6  (18.09) -38.8  (24.99)
Week 60 [N=89, 40, 43] -34.9  (23.57) -41.9  (22.92) -42.3  (24.00)
Week 72 [N=66, 34, 27] -37.7  (25.64) -44.6  (22.32) -43.8  (18.34)
Week 88 [N=42, 25, 22] -41.9  (23.81) -44.8  (19.42) -45.4  (19.00)
Week 100 [N=21, 12, 13] -45.2  (18.56) -42.2  (12.93) -47.6  (17.04)
Week 112 [N=13, 8, 6] -45.2  (22.11) -51.4  (13.11) -29.0  (33.15)
Week 124 [N=2, 1, 1] -54.5  (0.71) -49.0 [1]   (NA) -39.0 [1]   (NA)
End of Study Visit [N=102, 53, 53] -25.6  (27.23) -29.7  (25.95) -31.8  (29.28)
[1]
Mean based on 1 participant. Standard deviation can not be calculated.
28.Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire (HAQ) Score During the Extension Study
Hide Description The patient health assessment questionnaire (HAQ) was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from Baseline score indicates improvement in disability status.
Time Frame Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 107 58 56
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 24 [N=106, 58, 56] -0.241  (0.5430) -0.304  (0.4895) -0.239  (0.5142)
Week 36 [N=99, 49, 48] -0.266  (0.5418) -0.347  (0.5066) -0.302  (0.5511)
Week 48 [N=96, 44, 47] -0.322  (0.5446) -0.324  (0.4988) -0.293  (0.5375)
Week 60 [N=86, 40, 42] -0.347  (0.5552) -0.419  (0.5819) -0.425  (0.6047)
Week 72 [N=65, 34, 27] -0.398  (0.6047) -0.441  (0.5849) -0.449  (0.6338)
Week 88 [N=44, 25, 23] -0.472  (0.5985) -0.440  (0.5218) -0.451  (0.5823)
Week 100 [N=21, 13, 14] -0.613  (0.5504) -0.298  (0.4692) -0.563  (0.7448)
Week 112 [N=13, 8, 6] -0.538  (0.5410) -0.406  (0.6640) -0.542  (0.7100)
Week 124 [N=2, 1, 1] -0.938  (0.6187) -0.625 [1]   (NA) -1.250 [1]   (NA)
End of Study Visit [N=101, 54, 54] -0.260  (0.6051) -0.322  (0.5724) -0.291  (0.6259)
[1]
Mean based on 1 participant. Standard deviation can not be calculated.
29.Secondary Outcome
Title Change From Baseline in High-sensitive C-Reactive Protein (hsCRP) Levels During the Extension Study
Hide Description HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.
Time Frame Baseline and Weeks 24, 36, 48, 60, 72, 88, 100, 112 and 124.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 106 58 55
Mean (Standard Deviation)
Unit of Measure: mg/L
Week 24 [N=106, 58, 55] -4.82  (17.914) -6.45  (14.556) -9.59  (18.388)
Week 36 [N=97, 49, 50] -7.76  (16.771) -4.57  (14.393) 0.50  (71.610)
Week 48 [N=95, 44, 47] -5.61  (22.335) -4.63  (13.521) -11.04  (20.261)
Week 60 [N=88, 40, 43] -6.93  (21.160) 0.49  (47.139) -7.04  (18.638)
Week 72 [N=63, 33, 26] -9.02  (18.067) -5.29  (15.219) -7.70  (18.221)
Week 88 [N=44, 24, 22] -8.45  (19.060) -7.31  (13.035) -7.65  (18.098)
Week 100 [N=21, 14, 12] -7.29  (12.850) -2.74  (17.273) -10.74  (24.539)
Week 112 [N=13, 9, 6] -5.75  (10.438) -1.80  (18.838) -19.33  (35.567)
Week 124 [N=2, 1, 1] 4.95  (13.364) -22.70 [1]   (NA) 0.20 [1]   (NA)
End of Study Visit [N=101, 57, 52] -7.01  (17.934) -2.94  (15.735) -9.74  (20.766)
[1]
Mean based on 1 participant. Standard deviation can not be calculated.
30.Secondary Outcome
Title Change From Baseline in Erythrocyte Sedimentation Rate During the Extension Study
Hide Description Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. A negative change from Baseline score indicates improvement.
Time Frame Baseline and Weeks 24, 36, 48, 60, 72 and 88.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Extension Study ITT population. At each timepoint, only patients with a value at both Baseline and that timepoint are included (N).
Arm/Group Title Canakinumab 300 mg q2wk Canakinumab 150 mg q4wk Placebo
Hide Arm/Group Description:
Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
Overall Number of Participants Analyzed 105 58 54
Mean (Standard Deviation)
Unit of Measure: mm/hr
Week 24 [N=105, 58, 54] -14.9  (17.31) -18.3  (14.96) -16.8  (17.10)
Week 36 [N=95, 46, 48] -14.5  (18.99) -13.6  (19.09) -11.3  (25.94)
Week 48 [N=91, 42, 47] -15.6  (20.13) -16.6  (13.44) -17.0  (18.81)
Week 60 [N=85, 39, 43] -17.2  (19.07) -15.8  (19.08) -16.7  (19.09)
Week 72 [N=64, 34, 26] -18.6  (17.83) -15.3  (16.39) -14.1  (23.10)
Week 88 [N=42, 24, 23] -19.7  (17.46) -13.5  (16.38) -13.3  (20.89)
End of Study Visit [N=98, 55, 55] -14.9  (18.09) -14.0  (17.51) -15.9  (18.10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACZ885 600mg iv + 300mg sc q2wk ACZ885 300mg sc q2wk ACZ885 150mg sc q4wk Placebo
Hide Arm/Group Description ACZ885 600mg iv + 300mg sc q2wk ACZ885 300mg sc q2wk ACZ885 150mg sc q4wk Placebo
All-Cause Mortality
ACZ885 600mg iv + 300mg sc q2wk ACZ885 300mg sc q2wk ACZ885 150mg sc q4wk Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ACZ885 600mg iv + 300mg sc q2wk ACZ885 300mg sc q2wk ACZ885 150mg sc q4wk Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/71 (15.49%)   16/64 (25.00%)   12/69 (17.39%)   16/70 (22.86%) 
Blood and lymphatic system disorders         
Anaemia  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Cardiac disorders         
Atrial fibrillation  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Tachyarrhythmia  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Ear and labyrinth disorders         
Sudden hearing loss  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Eye disorders         
Cataract  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Gastrointestinal disorders         
Abdominal hernia obstructive  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Ascites  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Colitis  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Diarrhoea  1  1/71 (1.41%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Duodenal ulcer  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Dyspepsia  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Gastric ulcer haemorrhage  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  1/70 (1.43%) 
Gastritis  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Intestinal perforation  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Large intestine perforation  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
General disorders         
Chest pain  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Malaise  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Infections and infestations         
Abscess limb  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Appendicitis  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Arthritis bacterial  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Bronchitis  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Cellulitis  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Chronic sinusitis  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Device related infection  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Diverticulitis  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Erysipelas  1  1/71 (1.41%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Infected epidermal cyst  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Meningitis  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Respiratory tract infection  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Soft tissue infection  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Subcutaneous abscess  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Urinary tract infection  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Urosepsis  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Wound infection  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Injury, poisoning and procedural complications         
Epicondylitis  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Radius fracture  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Seroma  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Tendon rupture  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Thoracic vertebral fracture  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Investigations         
Tumour marker increased  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Musculoskeletal and connective tissue disorders         
Cervical spinal stenosis  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Foot deformity  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Hand deformity  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Intervertebral disc protrusion  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Lumbar spinal stenosis  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Osteoarthritis  1  0/71 (0.00%)  1/64 (1.56%)  2/69 (2.90%)  0/70 (0.00%) 
Rheumatoid arthritis  1  1/71 (1.41%)  1/64 (1.56%)  1/69 (1.45%)  3/70 (4.29%) 
Rheumatoid nodule  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Spinal osteoarthritis  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Angiomyolipoma  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Lung adenocarcinoma  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Lung adenocarcinoma metastatic  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Non-Hodgkin's lymphoma  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Squamous cell carcinoma of skin  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Nervous system disorders         
Cervical myelopathy  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Ischaemic stroke  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Transient ischaemic attack  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Psychiatric disorders         
Depression  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  1/70 (1.43%) 
Renal and urinary disorders         
Renal colic  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Reproductive system and breast disorders         
Ovarian cyst  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Uterine haemorrhage  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/71 (0.00%)  0/64 (0.00%)  1/69 (1.45%)  0/70 (0.00%) 
Dyspnoea  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Pulmonary embolism  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Respiratory failure  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Vascular disorders         
Deep vein thrombosis  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Hypertension  1  0/71 (0.00%)  1/64 (1.56%)  1/69 (1.45%)  0/70 (0.00%) 
Peripheral arterial occlusive disease  1  1/71 (1.41%)  0/64 (0.00%)  0/69 (0.00%)  0/70 (0.00%) 
Thromboangiitis obliterans  1  0/71 (0.00%)  0/64 (0.00%)  0/69 (0.00%)  1/70 (1.43%) 
Thrombophlebitis  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Venous thrombosis limb  1  0/71 (0.00%)  1/64 (1.56%)  0/69 (0.00%)  0/70 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ACZ885 600mg iv + 300mg sc q2wk ACZ885 300mg sc q2wk ACZ885 150mg sc q4wk Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   42/71 (59.15%)   38/64 (59.38%)   39/69 (56.52%)   40/70 (57.14%) 
Gastrointestinal disorders         
Diarrhoea  1  5/71 (7.04%)  6/64 (9.38%)  3/69 (4.35%)  5/70 (7.14%) 
Dyspepsia  1  1/71 (1.41%)  1/64 (1.56%)  4/69 (5.80%)  0/70 (0.00%) 
Nausea  1  4/71 (5.63%)  5/64 (7.81%)  1/69 (1.45%)  4/70 (5.71%) 
General disorders         
Fatigue  1  3/71 (4.23%)  3/64 (4.69%)  3/69 (4.35%)  5/70 (7.14%) 
Oedema peripheral  1  3/71 (4.23%)  4/64 (6.25%)  4/69 (5.80%)  6/70 (8.57%) 
Infections and infestations         
Bronchitis  1  6/71 (8.45%)  6/64 (9.38%)  4/69 (5.80%)  3/70 (4.29%) 
Gastroenteritis  1  6/71 (8.45%)  2/64 (3.13%)  0/69 (0.00%)  4/70 (5.71%) 
Influenza  1  1/71 (1.41%)  2/64 (3.13%)  4/69 (5.80%)  3/70 (4.29%) 
Nasopharyngitis  1  14/71 (19.72%)  12/64 (18.75%)  12/69 (17.39%)  10/70 (14.29%) 
Sinusitis  1  5/71 (7.04%)  0/64 (0.00%)  1/69 (1.45%)  1/70 (1.43%) 
Upper respiratory tract infection  1  6/71 (8.45%)  8/64 (12.50%)  5/69 (7.25%)  8/70 (11.43%) 
Urinary tract infection  1  7/71 (9.86%)  5/64 (7.81%)  3/69 (4.35%)  4/70 (5.71%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  6/71 (8.45%)  3/64 (4.69%)  5/69 (7.25%)  6/70 (8.57%) 
Back pain  1  2/71 (2.82%)  4/64 (6.25%)  3/69 (4.35%)  4/70 (5.71%) 
Myalgia  1  2/71 (2.82%)  2/64 (3.13%)  4/69 (5.80%)  1/70 (1.43%) 
Osteoarthritis  1  4/71 (5.63%)  4/64 (6.25%)  1/69 (1.45%)  0/70 (0.00%) 
Rheumatoid arthritis  1  3/71 (4.23%)  8/64 (12.50%)  6/69 (8.70%)  7/70 (10.00%) 
Tendonitis  1  0/71 (0.00%)  3/64 (4.69%)  1/69 (1.45%)  4/70 (5.71%) 
Nervous system disorders         
Dizziness  1  2/71 (2.82%)  2/64 (3.13%)  1/69 (1.45%)  4/70 (5.71%) 
Headache  1  8/71 (11.27%)  4/64 (6.25%)  4/69 (5.80%)  4/70 (5.71%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  3/71 (4.23%)  5/64 (7.81%)  5/69 (7.25%)  5/70 (7.14%) 
Skin and subcutaneous tissue disorders         
Rash  1  0/71 (0.00%)  1/64 (1.56%)  4/69 (5.80%)  1/70 (1.43%) 
Vascular disorders         
Hypertension  1  3/71 (4.23%)  6/64 (9.38%)  3/69 (4.35%)  2/70 (2.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00424346     History of Changes
Obsolete Identifiers: NCT00471198, NCT00784628
Other Study ID Numbers: CACZ885A2201
CACZ885A2201E1
CACZ885A2201E2
First Submitted: January 17, 2007
First Posted: January 19, 2007
Results First Submitted: April 2, 2013
Results First Posted: June 19, 2013
Last Update Posted: February 10, 2014