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To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee

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ClinicalTrials.gov Identifier: NCT01160822
Recruitment Status : Completed
First Posted : July 12, 2010
Results First Posted : August 30, 2012
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Biological: Canakinumab
Drug: Placebo to canakinumab
Drug: Naproxen
Drug: Placebo to Naproxen
Enrollment 169
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part A: Placebo Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description Participants received a single intra-articular injection of 150 mg canakinumab. Participants received a single intra-articular injection of 300 mg canakinumab. Participants received a single intra-articular injection of 600 mg canakinumab. Participants received a single intra-articular injection of canakinumab-matching placebo. Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Period Title: Overall Study
Started 6 7 6 5 45 47 53
Completed 6 7 6 5 36 40 44
Not Completed 0 0 0 0 9 7 9
Reason Not Completed
Adverse Event             0             0             0             0             1             2             5
Unsatisfactory therapeutic effect             0             0             0             0             4             5             3
Withdrawal by Subject             0             0             0             0             0             0             1
Lost to Follow-up             0             0             0             0             1             0             0
Administrative problems             0             0             0             0             1             0             0
Protocol deviation             0             0             0             0             2             0             0
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part A: Placebo Part B: Canakinumab Part B: Placebo Part B: Naproxen Total
Hide Arm/Group Description Participants received a single intra-articular injection of 150 mg canakinumab. Participants received a single intra-articular injection of 300 mg canakinumab. Participants received a single intra-articular injection of 600 mg canakinumab. Participants received a single intra-articular injection of canakinumab-matching placebo. Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 6 7 6 5 45 47 53 169
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 6 participants 5 participants 45 participants 47 participants 53 participants 169 participants
58.3  (12.79) 61.0  (9.63) 64.2  (10.68) 57.8  (7.76) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 60.5  (10.07)
[1]
Age demographic data for Study Part A.
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 6 participants 5 participants 45 participants 47 participants 53 participants 169 participants
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 61.4  (8.96) 60.3  (9.71) 62.2  (8.10) 61.3  (8.89)
[1]
Age demographic data for Study Part B.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 6 participants 5 participants 45 participants 47 participants 53 participants 169 participants
Female
3
  50.0%
4
  57.1%
2
  33.3%
2
  40.0%
31
  68.9%
31
  66.0%
34
  64.2%
107
  63.3%
Male
3
  50.0%
3
  42.9%
4
  66.7%
3
  60.0%
14
  31.1%
16
  34.0%
19
  35.8%
62
  36.7%
1.Primary Outcome
Title Part A: Number of Participants With Intolerance Events
Hide Description An intolerance event is defined as an acute inflammatory reaction, characterized by a 30 mm increase in pain (on a 100 mm visual analog scale (VAS) and associated with a new or worsened synovial fluid effusion within 3 days following the intra-articular (i.a.) injection. If baseline VAS pain score is ≥ 70 mm, an intolerance event is defined as an increase in pain by 20 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline VAS pain score is ≥ 80 mm, an intolerance event is defined as an increase in pain by 10 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline pain score is ≥ 90 mm, an intolerance event is defined as the patients experiencing an unspecified increase in pain on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection.
Time Frame Baseline to Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set.
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part A: Placebo
Hide Arm/Group Description:
Participants received a single intra-articular injection of 150 mg canakinumab.
Participants received a single intra-articular injection of 300 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab.
Participants received a single intra-articular injection of canakinumab-matching placebo.
Overall Number of Participants Analyzed 6 7 6 5
Measure Type: Number
Unit of Measure: participants
0 0 0 0
2.Primary Outcome
Title Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)
Hide Description

After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm). A negative change from Baseline score indicates improvement.

Results are from a Bayesian analysis of covariance (ANCOVA) model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and subject as random effects.

Time Frame Baseline and Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 42 44 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
-26.7  (4.05) -26.5  (3.97) -27.6  (3.82)
3.Primary Outcome
Title Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale
Hide Description

The Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale asks patients to rate pain in the index knee joint in the last 48 hours doing different activities on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0 to 20, where higher scores indicate more pain. A negative change from Baseline score indicates improvement.

Results are from a Bayesian ANCOVA model, fitting baseline WOMAC pain score as a covariate, time by treatment as fixed effects, region and patient as random effects.

Time Frame Baseline and Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 42 44 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.5  (0.71) -4.0  (0.68) -4.5  (0.65)
4.Secondary Outcome
Title Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)
Hide Description

After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).

Results are from a Bayesian ANCOVA model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and patient as random effects.

Time Frame Baseline and Weeks 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 43 44 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 -25.6  (4.03) -31.1  (4.03) -36.1  (3.84)
Week 8 -26.2  (4.12) -30.9  (4.06) -33.0  (3.89)
Week 12 -25.1  (4.14) -32.1  (4.06) -27.8  (3.94)
5.Secondary Outcome
Title Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)
Hide Description A responder is defined as a participant with a 50% or greater reduction from baseline on the VAS scale for pain assessment. After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).
Time Frame Baseline, Day 4, Weeks 1, 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data. N is the number of participants with available data at each time point.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 43 44 49
Measure Type: Number
Unit of Measure: percentage of participants
Day 4 [N=42, 44, 48] 50.0 43.2 47.9
Week 1 [N=42, 44, 48] 40.5 45.5 56.3
Week 2 [N=41, 44, 48] 46.3 43.2 62.5
Week 4 [N=39, 40, 46] 51.3 55.0 71.7
Week 8 [N=36, 38, 43] 52.8 50.0 55.8
Week 12 [N=35, 37, 41] 48.6 51.4 53.7
6.Secondary Outcome
Title Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales
Hide Description

The WOMAC consists of 3 subscales:

The Pain subscale asks patients to rate pain in the index knee joint in the last 48 hours during walking, using stairs, in bed, sitting or lying, and standing on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0-20.

The Stiffness subscale assesses stiffness in the index knee joint during the last 48 hours doing different activities on a scale from none (0) to extreme stiffness (4). The total stiffness subscale score ranges from 0-8.

The Physical Function subscale assesses difficulty performing daily physical activities during the last 48 hours on a scale from none (0) to extreme difficulty (4). The total physical function subscale score ranges from 0-68.

Higher scores indicate more pain/stiffness/difficulty. Results are from a Bayesian ANCOVA model, with baseline WOMAC score as a covariate, time by treatment as fixed effects, region and patient as random effects.

Time Frame Baseline and Weeks 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 43 44 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain at Week 8 -3.7  (0.72) -4.2  (0.69) -4.6  (0.66)
Pain at Week 12 -3.2  (0.72) -4.5  (0.69) -4.0  (0.66)
Stiffness at Week 4 -1.3  (0.36) -1.5  (0.36) -1.9  (0.34)
Stiffness at Week 8 -1.3  (0.37) -1.5  (0.36) -2.0  (0.35)
Stiffness at Week 12 -1.1  (0.37) -1.7  (0.37) -1.4  (0.35)
Function at Week 4 [N=38, 39, 43] -14.1  (1.93) -15.9  (1.93) -16.2  (1.76)
Function at Week 8 [N=35, 36, 41] -13.7  (1.97) -14.9  (1.94) -16.1  (1.77)
Function at Week 12 [N= 33, 36, 39] -13.4  (2.01) -16.5  (1.96) -14.4  (1.80)
7.Secondary Outcome
Title Part B: Proportion of Participants Who Used Rescue Analgesic During Study
Hide Description Participants were permitted to take oral rescue medication (Acetaminophen ≤ 4 gram/day) up until 24 hours of a scheduled assessment visit during the 12-week treatment period. The estimates shown are the Kaplan-Meier estimates of the proportion of participants that took rescue medication.
Time Frame Day 4, Weeks 1, 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (all participants as assigned that received at least one dose of study drug).
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 45 47 53
Measure Type: Number
Unit of Measure: proportion of participants
Day 4 0.27 0.30 0.19
Week 1 0.45 0.47 0.23
Week 2 0.52 0.57 0.33
Week 4 0.55 0.60 0.43
Week 8 0.57 0.69 0.59
Week 12 0.62 0.75 0.70
8.Secondary Outcome
Title Patient’s Global Assessment of Response to Treatment on Day 4
Hide Description Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Time Frame Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 42 44 48
Measure Type: Number
Unit of Measure: participants
Excellent 6 8 4
Good 14 16 20
Acceptable 11 13 16
Poor 5 5 6
Very poor 6 2 2
9.Secondary Outcome
Title Patient's Global Assessment of Response to Treatment at Week 2
Hide Description Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Time Frame Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 41 43 48
Measure Type: Number
Unit of Measure: participants
Excellent 5 6 11
Good 12 16 19
Acceptable 13 14 12
Poor 9 5 5
Very poor 2 2 1
10.Secondary Outcome
Title Patient's Global Assessment of Response to Treatment at Week 4
Hide Description Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 39 40 46
Measure Type: Number
Unit of Measure: participants
Excellent 5 6 9
Good 15 16 18
Acceptable 10 10 13
Poor 8 6 4
Very poor 1 2 2
11.Secondary Outcome
Title Patient's Global Assessment of Response to Treatment at Week 8
Hide Description Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 36 38 43
Measure Type: Number
Unit of Measure: participants
Excellent 5 5 10
Good 9 19 18
Acceptable 11 8 9
Poor 9 5 5
Very poor 2 1 1
12.Secondary Outcome
Title Patient's Global Assessment of Response to Treatment at Week 12
Hide Description Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 35 37 41
Measure Type: Number
Unit of Measure: participants
Excellent 4 8 7
Good 12 13 15
Acceptable 7 14 13
Poor 11 2 5
Very poor 1 0 1
13.Secondary Outcome
Title Part B: Physician's Global Assessment of Response to Treatment at Day 4
Hide Description The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Time Frame Day 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 42 44 48
Measure Type: Number
Unit of Measure: participants
Excellent 8 7 6
Good 11 18 21
Acceptable 16 14 13
Poor 4 3 7
Very poor 3 2 1
14.Secondary Outcome
Title Part B: Physician's Global Assessment of Response to Treatment at Week 2
Hide Description The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Time Frame Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 40 44 48
Measure Type: Number
Unit of Measure: participants
Excellent 7 5 15
Good 15 20 20
Acceptable 10 13 9
Poor 6 4 4
Very poor 2 2 0
15.Secondary Outcome
Title Part B: Physician's Global Assessment of Response to Treatment at Week 4
Hide Description The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 39 40 46
Measure Type: Number
Unit of Measure: participants
Excellent 4 5 9
Good 15 20 21
Acceptable 14 11 12
Poor 5 3 4
Very poor 1 1 0
16.Secondary Outcome
Title Part B: Physician's Global Assessment of Response to Treatment at Week 8
Hide Description The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 36 38 43
Measure Type: Number
Unit of Measure: participants
Excellent 5 3 9
Good 13 22 16
Acceptable 10 11 13
Poor 7 2 5
Very poor 1 0 0
17.Secondary Outcome
Title Part B: Physician's Global Assessment of Response to Treatment at Week 12
Hide Description The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic analysis set, where data were available.
Arm/Group Title Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description:
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 35 37 41
Measure Type: Number
Unit of Measure: participants
Excellent 5 7 10
Good 13 16 15
Acceptable 6 12 8
Poor 9 2 7
Very poor 2 0 1
18.Secondary Outcome
Title Maximum Observed Plasma Concentration of Canakinumab (Cmax)
Hide Description [Not Specified]
Time Frame Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set where data were available.
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part B: Canakinumab
Hide Arm/Group Description:
Participants received a single intra-articular injection of 150 mg canakinumab.
Participants received a single intra-articular injection of 300 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 6 6 6 39
Mean (Standard Deviation)
Unit of Measure: µg/mL
23.0  (8.54) 34.8  (11.3) 65.5  (14.5) 77.8  (22.8)
19.Secondary Outcome
Title Time to Reach the Maximum Observed Plasma Concentration of Canakinumab (Tmax)
Hide Description [Not Specified]
Time Frame Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set where data were available.
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part B: Canakinumab
Hide Arm/Group Description:
Participants received a single intra-articular injection of 150 mg canakinumab.
Participants received a single intra-articular injection of 300 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 6 6 6 39
Median (Full Range)
Unit of Measure: hours
96.2
(74.6 to 164)
86.7
(71.8 to 174)
144
(71.5 to 197)
95.9
(46.3 to 335)
20.Secondary Outcome
Title Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUClast)
Hide Description [Not Specified]
Time Frame Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set where data were available.
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part B: Canakinumab
Hide Arm/Group Description:
Participants received a single intra-articular injection of 150 mg canakinumab.
Participants received a single intra-articular injection of 300 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 6 6 6 35
Mean (Standard Deviation)
Unit of Measure: µg*day/mL
16900  (4430) 30700  (8380) 56100  (23900) 71900  (23800)
21.Secondary Outcome
Title Area Under the Concentration Time Curve From Time Zero to Infinity AUC(0-inf)
Hide Description [Not Specified]
Time Frame Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set where data were available.
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part B: Canakinumab
Hide Arm/Group Description:
Participants received a single intra-articular injection of 150 mg canakinumab.
Participants received a single intra-articular injection of 300 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 5 6 5 33
Mean (Standard Deviation)
Unit of Measure: µg*day/mL
16900  (4780) 32400  (8010) 49300  (16100) 78300  (28000)
22.Secondary Outcome
Title Terminal Phase Half-life (t1/2) of Canakinumab
Hide Description The time it takes for the concentration level of canakinumab to fall to 50% of the original value.
Time Frame Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set where data were available.
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part B: Canakinumab
Hide Arm/Group Description:
Participants received a single intra-articular injection of 150 mg canakinumab.
Participants received a single intra-articular injection of 300 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 5 6 5 34
Mean (Standard Deviation)
Unit of Measure: hours
539  (47.1) 578  (145) 474  (93.6) 736  (243)
23.Secondary Outcome
Title Apparent Clearance of Canakinumab From Plasma (CL/F)
Hide Description [Not Specified]
Time Frame Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set, where data were available.
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part B: Canakinumab
Hide Arm/Group Description:
Participants received a single intra-articular injection of 150 mg canakinumab.
Participants received a single intra-articular injection of 300 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 5 6 5 33
Mean (Standard Deviation)
Unit of Measure: mL/hr
9.58  (3.08) 9.66  (2.03) 13.3  (4.27) 8.65  (3.02)
24.Secondary Outcome
Title Apparent Volume of Distribution During Terminal Phase (Vz/F)
Hide Description [Not Specified]
Time Frame Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic analysis set, where data were available.
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part B: Canakinumab
Hide Arm/Group Description:
Participants received a single intra-articular injection of 150 mg canakinumab.
Participants received a single intra-articular injection of 300 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab.
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Overall Number of Participants Analyzed 5 6 5 33
Mean (Standard Deviation)
Unit of Measure: mL
7320  (1870) 8060  (2830) 8930  (3000) 8910  (4070)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part A: Placebo Part B: Canakinumab Part B: Placebo Part B: Naproxen
Hide Arm/Group Description Participants received a single intra-articular injection of 150 mg canakinumab. Participants received a single intra-articular injection of 300 mg canakinumab. Participants received a single intra-articular injection of 600 mg canakinumab. Participants received a single intra-articular injection of canakinumab-matching placebo. Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
All-Cause Mortality
Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part A: Placebo Part B: Canakinumab Part B: Placebo Part B: Naproxen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part A: Placebo Part B: Canakinumab Part B: Placebo Part B: Naproxen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/7 (0.00%)   1/6 (16.67%)   1/5 (20.00%)   0/45 (0.00%)   4/47 (8.51%)   4/53 (7.55%) 
Cardiac disorders               
Myocardial infarction  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  1/47 (2.13%)  0/53 (0.00%) 
Gastrointestinal disorders               
Small intestinal obstruction  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  1/53 (1.89%) 
General disorders               
Non-cardiac chest pain  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  1/47 (2.13%)  0/53 (0.00%) 
Infections and infestations               
Cellulitis  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Diverticulitis  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  1/47 (2.13%)  0/53 (0.00%) 
Influenza  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  1/53 (1.89%) 
Tooth infection  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  1/53 (1.89%) 
Injury, poisoning and procedural complications               
Meniscus lesion  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  1/53 (1.89%) 
Metabolism and nutrition disorders               
Dehydration  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Nervous system disorders               
Cerebrovascular accident  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  1/47 (2.13%)  0/53 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Epistaxis  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  1/53 (1.89%) 
Vascular disorders               
Orthostatic hypotension  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (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%
Part A: Canakinumab 150 mg Part A: Canakinumab 300 mg Part A: Canakinumab 600 mg Part A: Placebo Part B: Canakinumab Part B: Placebo Part B: Naproxen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   4/7 (57.14%)   3/6 (50.00%)   3/5 (60.00%)   17/45 (37.78%)   25/47 (53.19%)   26/53 (49.06%) 
Ear and labyrinth disorders               
Cerumen impaction  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Eye disorders               
Retinal tear  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Gastrointestinal disorders               
Abdominal pain upper  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/45 (0.00%)  1/47 (2.13%)  2/53 (3.77%) 
Diarrhoea  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  3/45 (6.67%)  4/47 (8.51%)  2/53 (3.77%) 
Dyspepsia  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/5 (20.00%)  0/45 (0.00%)  0/47 (0.00%)  3/53 (5.66%) 
Nausea  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/45 (0.00%)  4/47 (8.51%)  2/53 (3.77%) 
Vomiting  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  1/47 (2.13%)  1/53 (1.89%) 
General disorders               
Chest discomfort  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Fatigue  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  1/53 (1.89%) 
Pain  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/45 (0.00%)  0/47 (0.00%)  1/53 (1.89%) 
Infections and infestations               
Bronchitis  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  2/45 (4.44%)  0/47 (0.00%)  3/53 (5.66%) 
Cellulitis  1  0/6 (0.00%)  2/7 (28.57%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Gastroenteritis viral  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  3/53 (5.66%) 
Influenza  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/5 (0.00%)  2/45 (4.44%)  4/47 (8.51%)  2/53 (3.77%) 
Nasopharyngitis  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  3/45 (6.67%)  2/47 (4.26%)  7/53 (13.21%) 
Sinusitis  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/5 (20.00%)  1/45 (2.22%)  1/47 (2.13%)  1/53 (1.89%) 
Staphylococcal infection  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Tooth abscess  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Upper respiratory tract infection  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  1/45 (2.22%)  1/47 (2.13%)  0/53 (0.00%) 
Injury, poisoning and procedural complications               
Arthropod bite  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Arthropod sting  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Contusion  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  1/47 (2.13%)  3/53 (5.66%) 
Excoriation  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Metabolism and nutrition disorders               
Fluid retention  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Hypokalaemia  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/6 (0.00%)  2/7 (28.57%)  1/6 (16.67%)  0/5 (0.00%)  4/45 (8.89%)  6/47 (12.77%)  3/53 (5.66%) 
Back pain  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  1/45 (2.22%)  1/47 (2.13%)  4/53 (7.55%) 
Joint swelling  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  1/45 (2.22%)  0/47 (0.00%)  0/53 (0.00%) 
Neuropathic arthropathy  1  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Pain in extremity  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  4/53 (7.55%) 
Nervous system disorders               
Dizziness  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  3/47 (6.38%)  2/53 (3.77%) 
Headache  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  5/45 (11.11%)  6/47 (12.77%)  2/53 (3.77%) 
Respiratory, thoracic and mediastinal disorders               
Oropharyngeal pain  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  2/53 (3.77%) 
Sinus congestion  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  1/45 (2.22%)  3/47 (6.38%)  1/53 (1.89%) 
Skin and subcutaneous tissue disorders               
Dermatitis  1  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/5 (0.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Seborrhoea  1  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/5 (20.00%)  0/45 (0.00%)  0/47 (0.00%)  0/53 (0.00%) 
Vascular disorders               
Hypertension  1  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/5 (0.00%)  0/45 (0.00%)  2/47 (4.26%)  1/53 (1.89%) 
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 ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01160822     History of Changes
Other Study ID Numbers: CACZ885C2201
2009-015017-48 ( EudraCT Number )
First Submitted: July 9, 2010
First Posted: July 12, 2010
Results First Submitted: July 26, 2012
Results First Posted: August 30, 2012
Last Update Posted: October 30, 2012