Gout
Conditions
Keywords
Gout, Chronic gout, Gouty arthritis, Gout flares
Brief summary
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.
Interventions
DRUGCanakinumab
Canakinumab was supplied in glass vials as a lyophilized powder.
DRUGColchicine
0.5 mg capsule orally once daily for 16 weeks.
DRUGAllopurinol
100-300 mg orally once daily for 24 weeks.
Subcutaneous injection.
DRUGPlacebo Matching Colchicine
Capsule orally once daily for 16 weeks.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Core study Inclusion Criteria: * Signed written informed consent before any study procedure is performed. * History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy. * Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout. * Body Mass Index (BMI) ≤ 40 kg/m\^2. * Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped \> 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.
Exclusion criteria
* Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period. * History of allergy or contraindication to colchicine or allopurinol. * History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use. * History of bone marrow suppression. * Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone. Extension study Inclusion criteria: * Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9). * Patients who have signed a written informed consent before any trial procedure is performed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Core Study: Mean Number of Gout Flares Per Participant | Baseline of the core study to Week 16 | A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization | Baseline of the core study to Week 16 | The percentage of participants experiencing at least 1 gout flare within 16 weeks after randomization. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack. |
| Core Study: Percentage of Participants With Gout Flare at Different Time Points | Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study | A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack. |
| Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Baseline of the core study to Week 16 | Participants rated the intensity of pain in the most affected joint on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days. |
| Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Baseline of the core study to Week 16 | Participants assessed the intensity of pain in the most affected joint on a 5-point Likert scale, which ranged from 1 to 5 (1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days. |
| Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Days 15, 29, 57, 85, 113, and 141 of the core study | The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at Days 15, 29, 57, 85, 113, and 141. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported. |
| Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab | up to 16 weeks after randomization | — |
| Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Baseline of the extension study until the end of the study (up to 24 weeks) | Study participants made a global assessment of their response to treatment on a 5-point Likert scale (Excellent, Good, Acceptable, Slight, Poor) at the control visit 7±2 days following each of their first 3 flares. The number of participants in each of the 5 categories of the Likert scale are reported. |
| Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Baseline of the extension study until the end of the study (up to 24 weeks) | The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at the control visit 7±2 days following each of the first 3 flares. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported. |
| Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Baseline of the extension study until the end of the study (up to 24 weeks) | Tenderness was rated on a 0-3 point scale: 0=no pain, 1=patient states that there is pain, 2=patient states there is pain and winces, and 3=patient states there is pain, winces and withdraws on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0=no swelling, 1=palpable, 2=visible, and 3=bulging beyond the joint margins. Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits. |
| Extension Study: Amount of Rescue Medication Taken | Baseline of the extension study until the end of the study (up to 24 weeks) | The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded. |
| Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks) | Participant's rated the intensity of pain in the most affected joint during the first flare on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Assessments were made pre-dose and 24 hours, 3 days, 4 days, and an average of 5-7 days post-dose |
Countries
Argentina, Belgium, Colombia, Czechia, Germany, Guatemala, Hungary, Poland, Portugal, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
A total of 432 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Core Study: Canakinumab 25 mg Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. | 55 |
| Core Study: Canakinumab 50 mg Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. | 54 |
| Core Study: Canakinumab 100 mg Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. | 54 |
| Core Study: Canakinumab 200 mg Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. | 54 |
| Core Study: Canakinumab 300 mg Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks. | 53 |
| Core Study: Canakinumab q4wk Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks. | 53 |
| Core Study: Colchicine 0.5 mg Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85. | 108 |
| Total | 431 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Core Study | Abnormal Laboratory Value(s) | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Core Study | Administrative Problems | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Core Study | Adverse Event | 2 | 1 | 1 | 4 | 1 | 0 | 2 | 0 | 0 | 0 | 0 |
| Core Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Core Study | Lost to Follow-up | 2 | 1 | 2 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 |
| Core Study | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 1 | 3 | 0 | 0 | 0 | 0 |
| Core Study | Subject No Longer Requires Study Drug | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Core Study | Subject Withdrew Consent | 0 | 3 | 2 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
| Core Study | Unsatisfactory Therapeutic Effect | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Extension Study | Abnormal Laboratory Value(s) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Extension Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Extension Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 |
| Extension Study | Subject Withdrew Consent | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 |
Baseline characteristics
| Characteristic | Core Study: Canakinumab 25 mg | Core Study: Canakinumab 50 mg | Core Study: Canakinumab 100 mg | Core Study: Canakinumab 200 mg | Core Study: Canakinumab 300 mg | Core Study: Canakinumab q4wk | Core Study: Colchicine 0.5 mg | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 50.7 Years STANDARD_DEVIATION 9.72 | 54.4 Years STANDARD_DEVIATION 12.18 | 51.3 Years STANDARD_DEVIATION 12.41 | 52.6 Years STANDARD_DEVIATION 10.78 | 52.4 Years STANDARD_DEVIATION 11.3 | 52.8 Years STANDARD_DEVIATION 10.38 | 52.4 Years STANDARD_DEVIATION 10.69 | 52.4 Years STANDARD_DEVIATION 11.02 |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 6 Participants | 4 Participants | 2 Participants | 4 Participants | 7 Participants | 26 Participants |
| Sex: Female, Male Male | 55 Participants | 51 Participants | 48 Participants | 50 Participants | 51 Participants | 49 Participants | 101 Participants | 405 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 55 | 15 / 54 | 14 / 54 | 14 / 54 | 15 / 53 | 14 / 53 | 21 / 108 | 21 / 75 | 19 / 181 | 6 / 25 | 4 / 60 |
| serious Total, serious adverse events | 2 / 55 | 2 / 54 | 3 / 54 | 3 / 54 | 3 / 53 | 1 / 53 | 6 / 108 | 4 / 75 | 6 / 181 | 0 / 25 | 1 / 60 |
Outcome results
Primary
Core Study: Mean Number of Gout Flares Per Participant
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Time frame: Baseline of the core study to Week 16
Population: Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Canakinumab 25 mg | Core Study: Mean Number of Gout Flares Per Participant | 0.5 Gout flares | Standard Deviation 1.03 |
| Canakinumab 50 mg | Core Study: Mean Number of Gout Flares Per Participant | 0.4 Gout flares | Standard Deviation 1.82 |
| Canakinumab 100 mg | Core Study: Mean Number of Gout Flares Per Participant | 0.2 Gout flares | Standard Deviation 0.53 |
| Canakinumab 200 mg | Core Study: Mean Number of Gout Flares Per Participant | 0.4 Gout flares | Standard Deviation 1.35 |
| Canakinumab 300 mg | Core Study: Mean Number of Gout Flares Per Participant | 0.2 Gout flares | Standard Deviation 0.53 |
| Canakinumab q4wk | Core Study: Mean Number of Gout Flares Per Participant | 0.7 Gout flares | Standard Deviation 2.24 |
| Core Study: Colchicine 0.5 mg | Core Study: Mean Number of Gout Flares Per Participant | 0.7 Gout flares | Standard Deviation 1 |
Secondary
Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab
Time frame: up to 16 weeks after randomization
Population: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Canakinumab 25 mg | Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab | 0.48 gout flares per patient | Standard Error 0.204 |
| Canakinumab 50 mg | Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab | 0.43 gout flares per patient | Standard Error 0.207 |
| Canakinumab 100 mg | Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab | 0.22 gout flares per patient | Standard Error 0.209 |
| Canakinumab 200 mg | Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab | 0.38 gout flares per patient | Standard Error 0.205 |
| Canakinumab 300 mg | Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab | 0.21 gout flares per patient | Standard Error 0.209 |
| Canakinumab q4wk | Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab | 0.68 gout flares per patient | Standard Error 0.209 |
Secondary
Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares
Participants rated the intensity of pain in the most affected joint on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.
Time frame: Baseline of the core study to Week 16
Population: Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 6, 31) | 31.8 Units on a scale | Standard Deviation 16.77 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 5, 38) | 31.5 Units on a scale | Standard Deviation 20.82 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 9, 8, 9, 8, 9, 48) | 41.1 Units on a scale | Standard Deviation 31.01 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 20.9 Units on a scale | Standard Deviation 16.91 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 1, 3, 18) | 19.6 Units on a scale | Standard Deviation 14.14 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 19.3 Units on a scale | Standard Deviation 14.79 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 7, 6, 5, 5, 7, 44) | 44.8 Units on a scale | Standard Deviation 30.06 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 7, 6, 5, 5, 7, 44) | 40.1 Units on a scale | Standard Deviation 26.73 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 5, 38) | 49.5 Units on a scale | Standard Deviation 18.48 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 48.0 Units on a scale | Standard Deviation 5.66 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | NA Units on a scale | — |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 9, 8, 9, 8, 9, 48) | 44.6 Units on a scale | Standard Deviation 15.82 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 6, 31) | 46.3 Units on a scale | Standard Deviation 10.6 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 1, 3, 18) | 44.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 6, 31) | 16.5 Units on a scale | Standard Deviation 23.33 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 9, 8, 9, 8, 9, 48) | 56.3 Units on a scale | Standard Deviation 26.72 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 7, 6, 5, 5, 7, 44) | 46.2 Units on a scale | Standard Deviation 35.11 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 5, 38) | 49.5 Units on a scale | Standard Deviation 25.29 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 0.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 1, 3, 18) | 0.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 0.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 1, 3, 18) | 57.5 Units on a scale | Standard Deviation 60.1 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 9, 8, 9, 8, 9, 48) | 53.0 Units on a scale | Standard Deviation 27.99 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 54.8 Units on a scale | Standard Deviation 43.38 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 5, 38) | 56.7 Units on a scale | Standard Deviation 40.91 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 7, 6, 5, 5, 7, 44) | 19.8 Units on a scale | Standard Deviation 32.05 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 6, 31) | 63.5 Units on a scale | Standard Deviation 33 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 35.0 Units on a scale | Standard Deviation 49.5 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 5, 38) | 26.3 Units on a scale | Standard Deviation 14.64 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 7, 6, 5, 5, 7, 44) | 43.1 Units on a scale | Standard Deviation 17.62 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 6, 31) | 11.0 Units on a scale | Standard Deviation 11 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 0.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 13.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 9, 8, 9, 8, 9, 48) | 52.2 Units on a scale | Standard Deviation 19.4 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 1, 3, 18) | 12.0 Units on a scale | Standard Deviation 0 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 7, 6, 5, 5, 7, 44) | 59.3 Units on a scale | Standard Deviation 23.53 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 52.0 Units on a scale | Standard Deviation 11.31 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 6, 31) | 49.4 Units on a scale | Standard Deviation 27.73 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 5, 38) | 58.0 Units on a scale | Standard Deviation 27.59 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 1, 3, 18) | 43.5 Units on a scale | Standard Deviation 24.38 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 9, 8, 9, 8, 9, 48) | 66.1 Units on a scale | Standard Deviation 15.07 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 41.4 Units on a scale | Standard Deviation 33.63 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 7, 6, 5, 5, 7, 44) | 42.8 Units on a scale | Standard Deviation 24.37 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 31.8 Units on a scale | Standard Deviation 29.91 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 5, 38) | 38.1 Units on a scale | Standard Deviation 23.37 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 6, 31) | 30.5 Units on a scale | Standard Deviation 26.68 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 1, 3, 18) | 33.7 Units on a scale | Standard Deviation 26.66 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 33.0 Units on a scale | Standard Deviation 22.16 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 9, 8, 9, 8, 9, 48) | 53.1 Units on a scale | Standard Deviation 24.18 |
Secondary
Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares
Participants assessed the intensity of pain in the most affected joint on a 5-point Likert scale, which ranged from 1 to 5 (1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.
Time frame: Baseline of the core study to Week 16
Population: Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 2.2 Units on a scale | Standard Deviation 0.69 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 2.4 Units on a scale | Standard Deviation 0.49 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 6, 6, 5, 5, 7, 44) | 2.9 Units on a scale | Standard Deviation 0.92 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 2, 3, 18) | 2.4 Units on a scale | Standard Deviation 0.49 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 6, 38) | 2.4 Units on a scale | Standard Deviation 0.73 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 8, 8, 9, 8, 9, 48) | 2.8 Units on a scale | Standard Deviation 0.88 |
| Canakinumab 25 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 7, 31) | 2.6 Units on a scale | Standard Deviation 0.57 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 6, 38) | 3.1 Units on a scale | Standard Deviation 0.63 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 7, 31) | 2.7 Units on a scale | Standard Deviation 0.58 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 6, 6, 5, 5, 7, 44) | 2.6 Units on a scale | Standard Deviation 1.02 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 2, 3, 18) | 3.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 8, 8, 9, 8, 9, 48) | 3.1 Units on a scale | Standard Deviation 0.65 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 2.5 Units on a scale | Standard Deviation 0.71 |
| Canakinumab 50 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | NA Units on a scale | — |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 1.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 2, 3, 18) | 1.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 6, 38) | 2.3 Units on a scale | Standard Deviation 0.96 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 1.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 7, 31) | 1.5 Units on a scale | Standard Deviation 0.71 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 6, 6, 5, 5, 7, 44) | 3.3 Units on a scale | Standard Deviation 1.51 |
| Canakinumab 100 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 8, 8, 9, 8, 9, 48) | 3.5 Units on a scale | Standard Deviation 1.2 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 7, 31) | 3.0 Units on a scale | Standard Deviation 1 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 6, 6, 5, 5, 7, 44) | 2.2 Units on a scale | Standard Deviation 1.1 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 8, 8, 9, 8, 9, 48) | 3.2 Units on a scale | Standard Deviation 0.92 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 6, 38) | 3.0 Units on a scale | Standard Deviation 1.15 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 3.2 Units on a scale | Standard Deviation 1.76 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 2, 3, 18) | 3.5 Units on a scale | Standard Deviation 2.12 |
| Canakinumab 200 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 2.5 Units on a scale | Standard Deviation 2.12 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 7, 31) | 1.7 Units on a scale | Standard Deviation 0.58 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 6, 6, 5, 5, 7, 44) | 2.9 Units on a scale | Standard Deviation 0.74 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 1.0 Units on a scale | Standard Deviation 0 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 8, 8, 9, 8, 9, 48) | 3.1 Units on a scale | Standard Deviation 0.35 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 2, 3, 18) | 1.5 Units on a scale | Standard Deviation 0.71 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 6, 38) | 2.3 Units on a scale | Standard Deviation 0.5 |
| Canakinumab 300 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 1.5 Units on a scale | Standard Deviation 0.71 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 6, 6, 5, 5, 7, 44) | 3.5 Units on a scale | Standard Deviation 1.05 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 6, 38) | 3.4 Units on a scale | Standard Deviation 1.07 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 2.7 Units on a scale | Standard Deviation 1.28 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 7, 31) | 3.2 Units on a scale | Standard Deviation 1.08 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 8, 8, 9, 8, 9, 48) | 3.8 Units on a scale | Standard Deviation 0.6 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 3.3 Units on a scale | Standard Deviation 0.47 |
| Canakinumab q4wk | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 2, 3, 18) | 2.9 Units on a scale | Standard Deviation 0.84 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 4 (n=7, 3, 2, 3, 3, 7, 31) | 2.4 Units on a scale | Standard Deviation 0.9 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 2 (n=12, 6, 6, 5, 5, 7, 44) | 3.0 Units on a scale | Standard Deviation 0.86 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 5 (n=7, 2, 1, 3, 2, 4, 22) | 2.6 Units on a scale | Standard Deviation 0.95 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 1 (n=15, 8, 8, 9, 8, 9, 48) | 3.2 Units on a scale | Standard Deviation 0.77 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 6 (n=6, 1, 1, 2, 2, 3, 18) | 2.5 Units on a scale | Standard Deviation 1.05 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 7 (n=6, 0, 1, 2, 1, 2, 16) | 2.4 Units on a scale | Standard Deviation 0.81 |
| Core Study: Colchicine 0.5 mg | Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares | Day 3 (n=10, 4, 4, 4, 4, 6, 38) | 2.7 Units on a scale | Standard Deviation 0.76 |
Secondary
Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization
The percentage of participants experiencing at least 1 gout flare within 16 weeks after randomization. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Time frame: Baseline of the core study to Week 16
Population: Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Canakinumab 25 mg | Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization | 27.3 Percentage of participants |
| Canakinumab 50 mg | Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization | 16.7 Percentage of participants |
| Canakinumab 100 mg | Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization | 14.8 Percentage of participants |
| Canakinumab 200 mg | Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization | 18.5 Percentage of participants |
| Canakinumab 300 mg | Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization | 15.1 Percentage of participants |
| Canakinumab q4wk | Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization | 16.7 Percentage of participants |
| Core Study: Colchicine 0.5 mg | Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization | 44.4 Percentage of participants |
Secondary
Core Study: Percentage of Participants With Gout Flare at Different Time Points
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Time frame: Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study
Population: Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab 25 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 days post-dose | 12.7 Percentage of participants |
| Canakinumab 25 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 days post-dose | 10.9 Percentage of participants |
| Canakinumab 25 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 weeks post-dose | 14.5 Percentage of participants |
| Canakinumab 25 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 10 weeks post-dose | 22.5 Percentage of participants |
| Canakinumab 25 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 weeks post-dose | 14.5 Percentage of participants |
| Canakinumab 25 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 weeks post-dose | 16.5 Percentage of participants |
| Canakinumab 25 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 days post-dose | 5.5 Percentage of participants |
| Canakinumab 25 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 16 weeks post-dose | 28.7 Percentage of participants |
| Canakinumab 50 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 weeks post-dose | 9.3 Percentage of participants |
| Canakinumab 50 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 weeks post-dose | 11.1 Percentage of participants |
| Canakinumab 50 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 days post-dose | 3.7 Percentage of participants |
| Canakinumab 50 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 16 weeks post-dose | 17.3 Percentage of participants |
| Canakinumab 50 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 days post-dose | 5.6 Percentage of participants |
| Canakinumab 50 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 10 weeks post-dose | 13.1 Percentage of participants |
| Canakinumab 50 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 weeks post-dose | 7.4 Percentage of participants |
| Canakinumab 50 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 days post-dose | 3.7 Percentage of participants |
| Canakinumab 100 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 days post-dose | 3.7 Percentage of participants |
| Canakinumab 100 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 weeks post-dose | 9.3 Percentage of participants |
| Canakinumab 100 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 16 weeks post-dose | 15.1 Percentage of participants |
| Canakinumab 100 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 weeks post-dose | 7.4 Percentage of participants |
| Canakinumab 100 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 days post-dose | 3.7 Percentage of participants |
| Canakinumab 100 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 weeks post-dose | 7.4 Percentage of participants |
| Canakinumab 100 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 days post-dose | 3.7 Percentage of participants |
| Canakinumab 100 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 10 weeks post-dose | 11.2 Percentage of participants |
| Canakinumab 200 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 10 weeks post-dose | 16.8 Percentage of participants |
| Canakinumab 200 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 16 weeks post-dose | 18.8 Percentage of participants |
| Canakinumab 200 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 days post-dose | 7.4 Percentage of participants |
| Canakinumab 200 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 days post-dose | 3.7 Percentage of participants |
| Canakinumab 200 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 weeks post-dose | 13.0 Percentage of participants |
| Canakinumab 200 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 weeks post-dose | 13.0 Percentage of participants |
| Canakinumab 200 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 days post-dose | 3.7 Percentage of participants |
| Canakinumab 200 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 weeks post-dose | 11.1 Percentage of participants |
| Canakinumab 300 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 weeks post-dose | 11.4 Percentage of participants |
| Canakinumab 300 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 days post-dose | 0.0 Percentage of participants |
| Canakinumab 300 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 days post-dose | 5.7 Percentage of participants |
| Canakinumab 300 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 days post-dose | 5.7 Percentage of participants |
| Canakinumab 300 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 weeks post-dose | 7.5 Percentage of participants |
| Canakinumab 300 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 weeks post-dose | 11.4 Percentage of participants |
| Canakinumab 300 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 10 weeks post-dose | 11.4 Percentage of participants |
| Canakinumab 300 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 16 weeks post-dose | 15.3 Percentage of participants |
| Canakinumab q4wk | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 weeks post-dose | 11.3 Percentage of participants |
| Canakinumab q4wk | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 weeks post-dose | 27.92 Percentage of participants |
| Canakinumab q4wk | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 days post-dose | 3.8 Percentage of participants |
| Canakinumab q4wk | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 days post-dose | 3.8 Percentage of participants |
| Canakinumab q4wk | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 16 weeks post-dose | 17.0 Percentage of participants |
| Canakinumab q4wk | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 10 weeks post-dose | 17.0 Percentage of participants |
| Canakinumab q4wk | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 days post-dose | 3.8 Percentage of participants |
| Canakinumab q4wk | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 weeks post-dose | 15.1 Percentage of participants |
| Core Study: Colchicine 0.5 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 weeks post-dose | 16.7 Percentage of participants |
| Core Study: Colchicine 0.5 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 weeks post-dose | 25.1 Percentage of participants |
| Core Study: Colchicine 0.5 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 16 weeks post-dose | 45.8 Percentage of participants |
| Core Study: Colchicine 0.5 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 weeks post-dose | 32.6 Percentage of participants |
| Core Study: Colchicine 0.5 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 6 days post-dose | 11.1 Percentage of participants |
| Core Study: Colchicine 0.5 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 10 weeks post-dose | 37.5 Percentage of participants |
| Core Study: Colchicine 0.5 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 4 days post-dose | 10.2 Percentage of participants |
| Core Study: Colchicine 0.5 mg | Core Study: Percentage of Participants With Gout Flare at Different Time Points | 2 days post-dose | 5.6 Percentage of participants |
Secondary
Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale
The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at Days 15, 29, 57, 85, 113, and 141. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.
Time frame: Days 15, 29, 57, 85, 113, and 141 of the core study
Population: Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Not assessed | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 : Very good | 24 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Fair | 5 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Not assessed | 1 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Fair | 3 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Very poor | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Very poor | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Poor | 1 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15: Very good | 19 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Good | 28 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Fair | 6 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Poor | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Very poor | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Good | 16 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Not assessed | 3 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57- Good | 21 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29: Very good | 26 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 : Very good | 26 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29- Good | 23 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Not Assessed | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Fair | 2 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Not Assessed | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Poor | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Very poor | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Very poor | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85: Very good | 27 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Not assessed | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Poor | 2 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57: Very good | 25 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Good | 20 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Fair | 5 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Fair | 5 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Poor | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - - Poor | 0 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Good | 18 Participants |
| Canakinumab 25 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Very poor | 0 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 : Very good | 29 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - - Poor | 0 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 : Very good | 25 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Fair | 3 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29: Very good | 24 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Fair | 4 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Fair | 2 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Poor | 0 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29- Good | 22 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Poor | 1 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Very poor | 1 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Poor | 0 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Very poor | 0 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Not Assessed | 3 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Very poor | 0 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Poor | 0 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Good | 18 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Fair | 4 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Not Assessed | 2 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Poor | 0 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15: Very good | 23 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Not assessed | 2 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Very poor | 0 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Fair | 2 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57- Good | 20 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57: Very good | 27 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Very poor | 1 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Good | 24 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Good | 17 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85: Very good | 31 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Good | 20 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Very poor | 1 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Not assessed | 2 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Not assessed | 1 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Fair | 3 Participants |
| Canakinumab 50 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Not assessed | 3 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Not assessed | 0 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15: Very good | 24 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Fair | 3 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Good | 23 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57- Good | 16 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Fair | 3 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Fair | 5 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Poor | 2 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Good | 19 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Very poor | 0 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Not assessed | 1 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Very poor | 0 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29: Very good | 25 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Fair | 6 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29- Good | 22 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Not Assessed | 1 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Good | 18 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Very poor | 0 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Poor | 1 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Poor | 2 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Very poor | 0 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Poor | 1 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Not assessed | 0 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 : Very good | 30 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Not assessed | 1 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85: Very good | 32 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Very poor | 0 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Fair | 2 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Good | 15 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57: Very good | 28 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Fair | 5 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - - Poor | 1 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Very poor | 0 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Not Assessed | 0 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 : Very good | 24 Participants |
| Canakinumab 100 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Poor | 3 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Poor | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Good | 20 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Poor | 1 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Very poor | 1 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Fair | 3 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Not Assessed | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15: Very good | 23 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29: Very good | 24 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Not assessed | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57- Good | 21 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Very poor | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Poor | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Good | 16 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 : Very good | 26 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Fair | 4 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Very poor | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Fair | 4 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Very poor | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Good | 12 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Very poor | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Fair | 3 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Good | 26 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Not Assessed | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Not assessed | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Poor | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29- Good | 26 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57: Very good | 27 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Very poor | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Poor | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Fair | 6 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Fair | 4 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 : Very good | 31 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Not assessed | 1 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - - Poor | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Not assessed | 0 Participants |
| Canakinumab 200 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85: Very good | 32 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Good | 17 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29: Very good | 27 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Poor | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Fair | 2 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Very poor | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Poor | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15: Very good | 27 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Good | 21 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Fair | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Poor | 3 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Very poor | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Not assessed | 1 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29- Good | 23 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Fair | 2 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Very poor | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Not assessed | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57: Very good | 30 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57- Good | 18 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Fair | 4 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Poor | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Very poor | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Not assessed | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85: Very good | 31 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - - Poor | 1 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Very poor | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Not assessed | 1 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 : Very good | 29 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Good | 20 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Fair | 1 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Poor | 1 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Not Assessed | 0 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 : Very good | 32 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Good | 14 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Fair | 2 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Very poor | 1 Participants |
| Canakinumab 300 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Not Assessed | 1 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Not assessed | 1 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Not assessed | 1 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Very poor | 0 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - - Poor | 2 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 : Very good | 32 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Poor | 2 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Fair | 3 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Not Assessed | 1 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Good | 15 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57- Good | 20 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57: Very good | 28 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Fair | 3 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Not assessed | 1 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Very poor | 0 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Poor | 2 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Fair | 2 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Very poor | 0 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29- Good | 22 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29: Very good | 27 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Not assessed | 2 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 : Very good | 32 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Very poor | 0 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Poor | 4 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Fair | 3 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Good | 14 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Good | 20 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15: Very good | 25 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Fair | 3 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Very poor | 1 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Poor | 2 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Fair | 3 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Not Assessed | 2 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Very poor | 1 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Good | 17 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85: Very good | 29 Participants |
| Canakinumab q4wk | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Poor | 2 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Good | 41 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Not assessed | 2 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Very poor | 1 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Fair | 16 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Poor | 3 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Fair | 16 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Not assessed | 5 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 : Very good | 50 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 : Very good | 41 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Fair | 9 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Very poor | 2 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57- Good | 43 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85: Very good | 43 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Poor | 6 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Good | 36 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Poor | 2 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57: Very good | 46 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Not Assessed | 8 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Not assessed | 3 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Very poor | 0 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - - Poor | 2 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Fair | 7 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Good | 36 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Very poor | 1 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15 - Good | 42 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 57 - Not assessed | 4 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Poor | 2 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Poor | 2 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Fair | 12 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29 - Fair | 19 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 15: Very good | 40 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 85 - Very poor | 0 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 113 - Very poor | 1 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29- Good | 42 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 141 - Not Assessed | 5 Participants |
| Core Study: Colchicine 0.5 mg | Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale | Day 29: Very good | 39 Participants |
Secondary
Extension Study: Amount of Rescue Medication Taken
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)
Population: Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Canakinumab 25 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 1: Naproxen (n=68, 24) | 1086.8 mg | Standard Deviation 1592.72 |
| Canakinumab 25 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 1: Prednisolone (68, 24) | 4.6 mg | Standard Deviation 20.84 |
| Canakinumab 25 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 2: Naproxen (n=12, 5) | 650.0 mg | Standard Deviation 642.79 |
| Canakinumab 25 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 2: Prednisolone (12, 5) | 1.3 mg | Standard Deviation 3.11 |
| Canakinumab 25 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 3: Naproxen (n=4, 1) | 250.0 mg | Standard Deviation 500 |
| Canakinumab 25 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 3: Prednisolone (4, 1) | 0.0 mg | Standard Deviation 0 |
| Canakinumab 50 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 3: Naproxen (n=4, 1) | 0.0 mg | Standard Deviation 0 |
| Canakinumab 50 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 1: Naproxen (n=68, 24) | 954.6 mg | Standard Deviation 1130.19 |
| Canakinumab 50 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 2: Prednisolone (12, 5) | 0.0 mg | Standard Deviation 0 |
| Canakinumab 50 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 1: Prednisolone (68, 24) | 4.2 mg | Standard Deviation 20.41 |
| Canakinumab 50 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 3: Prednisolone (4, 1) | 0.0 mg | Standard Deviation 0 |
| Canakinumab 50 mg | Extension Study: Amount of Rescue Medication Taken | Gout Flare 2: Naproxen (n=12, 5) | 200.0 mg | Standard Deviation 447.21 |
Secondary
Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare
Participant's rated the intensity of pain in the most affected joint during the first flare on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Assessments were made pre-dose and 24 hours, 3 days, 4 days, and an average of 5-7 days post-dose
Time frame: Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)
Population: Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Canakinumab 25 mg | Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | Pre-dose (n=65, 19) | 61.3 Units on a scale | Standard Deviation 27.13 |
| Canakinumab 25 mg | Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | 5-7 days (n=52, 13) | 8.1 Units on a scale | Standard Deviation 15.86 |
| Canakinumab 25 mg | Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | 24 hours (n=65, 18) | 23.8 Units on a scale | Standard Deviation 23.32 |
| Canakinumab 25 mg | Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | 3 days (n=54, 15) | 12.4 Units on a scale | Standard Deviation 16.82 |
| Canakinumab 25 mg | Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | 4 days (n=54, 15) | 8.8 Units on a scale | Standard Deviation 14.32 |
| Canakinumab 50 mg | Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | 4 days (n=54, 15) | 2.7 Units on a scale | Standard Deviation 5.06 |
| Canakinumab 50 mg | Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | 3 days (n=54, 15) | 6.8 Units on a scale | Standard Deviation 9.03 |
| Canakinumab 50 mg | Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | Pre-dose (n=65, 19) | 71.8 Units on a scale | Standard Deviation 20.86 |
| Canakinumab 50 mg | Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | 5-7 days (n=52, 13) | 2.1 Units on a scale | Standard Deviation 4.7 |
| Canakinumab 50 mg | Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare | 24 hours (n=65, 18) | 29.0 Units on a scale | Standard Deviation 22.85 |
Secondary
Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale
Study participants made a global assessment of their response to treatment on a 5-point Likert scale (Excellent, Good, Acceptable, Slight, Poor) at the control visit 7±2 days following each of their first 3 flares. The number of participants in each of the 5 categories of the Likert scale are reported.
Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)
Population: Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Poor (63, 21) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Poor (3, 1) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Excellent (63, 21) | 40 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Excellent (3, 1) | 2 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Good (63, 21) | 17 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Slight (11, 5) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Acceptable (63, 21) | 5 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Good (3, 1) | 1 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Excellent (11, 5) | 4 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Good (11, 5) | 6 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Acceptable (3, 1) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Acceptable (11, 5) | 1 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Poor (11, 5) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Slight (3, 1) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Slight (63, 21) | 1 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Poor (3, 1) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Poor (63, 21) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Excellent (11, 5) | 4 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Slight (11, 5) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Poor (11, 5) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Excellent (3, 1) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Good (3, 1) | 1 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Acceptable (3, 1) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Slight (3, 1) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Excellent (63, 21) | 7 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Good (63, 21) | 14 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Acceptable (63, 21) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Slight (63, 21) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Good (11, 5) | 1 Participants |
| Canakinumab 50 mg | Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Acceptable (11, 5) | 0 Participants |
Secondary
Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare
Tenderness was rated on a 0-3 point scale: 0=no pain, 1=patient states that there is pain, 2=patient states there is pain and winces, and 3=patient states there is pain, winces and withdraws on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0=no swelling, 1=palpable, 2=visible, and 3=bulging beyond the joint margins. Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.
Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)
Population: Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Control Visit: Pain, winces and withdra | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Flare Visit: Pain | 27 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Flare Visit: Pain, winces and withdraws | 17 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Control Visit: No pain | 60 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Control Visit: Pain and winces | 1 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Flare Visit: No pain | 2 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Flare Visit: No swelling | 5 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Flare Visit: Palpable | 20 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Flare Visit: Visible | 31 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Control Visit: No swelling | 61 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Control Visit: Palpable | 6 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Control Visit: Visible | 2 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Control Visit: Bulging beyond joint | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Flare Visit: Absent | 21 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Flare Visit: Present | 44 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Flare Visit: Not assessed | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Control Visit: Absent | 66 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Control Visit: Present | 3 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Control Visit: Not assessed | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Flare Visit: Pain and winces | 23 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Control Visit: Pain | 8 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Flare Visit: Bulging beyond joint | 13 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Control Visit: Palpable | 2 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Flare Visit: No pain | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Control Visit: Not assessed | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Flare Visit: Pain and winces | 10 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Control Visit: Visible | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Control Visit: Absent | 24 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Control Visit: No pain | 21 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Control Visit: Pain | 3 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Control Visit: Bulging beyond joint | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Control Visit: Pain and winces | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Flare Visit: Pain | 2 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Control Visit: Pain, winces and withdra | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Flare Visit: Absent | 4 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Flare Visit: No swelling | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Control Visit: Present | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Flare Visit: Palpable | 2 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Flare Visit: Present | 20 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Flare Visit: Visible | 17 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Flare Visit: Bulging beyond joint | 5 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Tenderness Flare Visit: Pain, winces and withdraws | 12 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Joint Swelling Control Visit: No swelling | 22 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare | Erythema Flare Visit: Not assessed | 0 Participants |
Secondary
Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale
The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at the control visit 7±2 days following each of the first 3 flares. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.
Time frame: Baseline of the extension study until the end of the study (up to 24 weeks)
Population: Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Fair (3, 1) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Poor (69, 23) | 2 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Very Good (69, 23) | 37 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Very Poor (69, 23) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Fair (12, 5) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Very Good (12, 5) | 5 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Poor (12, 5) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Fair (69, 23) | 2 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Very Good (3, 1) | 1 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Good (3, 1) | 2 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Good (69, 23) | 28 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Poor (3, 1) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Very Poor (12, 5) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Very Poor (3, 1) | 0 Participants |
| Canakinumab 25 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Good (12, 5) | 7 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Very Poor (3, 1) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Good (69, 23) | 10 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Fair (69, 23) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Poor (69, 23) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Very Good (12, 5) | 3 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Good (12, 5) | 2 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Fair (12, 5) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Poor (12, 5) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Very Good (3, 1) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Fair (3, 1) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Very Poor (69, 23) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 2: Very Poor (12, 5) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Good (3, 1) | 1 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 3: Poor (3, 1) | 0 Participants |
| Canakinumab 50 mg | Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale | Gout Flare 1: Very Good (69, 23) | 13 Participants |