Acute Gouty Arthritis
Conditions
Keywords
Gout, arthritis, gout flare, acute gout, gouty, rheumatic disease, uric acid, podagra
Brief summary
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
Interventions
DRUGCanakinumab 150mg in prefilled syringe
Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Uncontrolled
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Compliance and completion of the canakinumab PFS core study * Unchanged significant clinical medical history from entry into core study
Exclusion criteria
* Physician judgment of unsuitability for the study * Pregnant or nursing women Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Reported Adverse Events | From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participant With New Flares | up to 36 weeks | The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered. |
| Change From Baseline in Pain Intensity on a 5-point Likert Scale | Baseline, upto 14 days post-dose | A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days. |
| Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose | Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. |
| Probability of New Gout Flares at End of Study | Up to Day 337 | The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates. |
| Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Baseline, 7 days post-dose | Tenderness was measured on a 0-3 point scale: no pain, participant states that there is pain, participant states there is pain and winces and participant states there is pain, winces and withdraws on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable. |
| Number of Participants Responded for Physician's Global Assessment of Response to Treatment | 7 days post-dose | The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor. |
| Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | 48 weeks post-dose | Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor). |
Countries
Canada, Germany, Lithuania, United States
Participant flow
Recruitment details
This study was conducted at 68 centers at Canada, Germany, Lithuania, United States from 25-August-2011 (first participant first visit) to 09-May-2013 (last participant last visit).
Pre-assignment details
A total of 397 participants were randomized in the core study (CACZ885H2361 \[NCT01356602\]), out of which 232 participants entered the extension study (CACZ885H2361E1 \[NCT01431638\]).
Participants by arm
| Arm | Count |
|---|---|
| Canakinumab, Pre-filled Syringes (PFS) Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes. | 133 |
| Canakinumab, Lyophilizate (LYO) Participants received 150 mg S.C at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. | 132 |
| Triamcinolone Acetonide Participants received 40 mg intramuscular (IM) at randomization and upon new flare. | 132 |
| Total | 397 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative problems | 1 | 4 | 6 |
| Overall Study | Adverse Event | 1 | 3 | 1 |
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 7 | 9 | 7 |
| Overall Study | Participants condition no longer requires study drug | 0 | 1 | 0 |
| Overall Study | Participants Did not enter extension study from core study | 39 | 46 | 32 |
| Overall Study | Participant withdrew consent | 14 | 5 | 8 |
| Overall Study | Protocol deviation | 1 | 1 | 4 |
| Overall Study | Unsatisfactory therapeutic effect | 2 | 2 | 4 |
Baseline characteristics
| Characteristic | Total | Canakinumab, Pre-filled Syringes (PFS) | Canakinumab, Lyophilizate (LYO) | Triamcinolone Acetonide |
|---|---|---|---|---|
| Age, Customized >= 65-74 years | 57 Participants | 15 Participants | 24 Participants | 18 Participants |
| Age, Customized < 65 years | 327 Participants | 113 Participants | 104 Participants | 110 Participants |
| Age, Customized >= 75 years | 13 Participants | 5 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants | 4 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Black | 95 Participants | 35 Participants | 31 Participants | 29 Participants |
| Race/Ethnicity, Customized Caucasian | 283 Participants | 93 Participants | 93 Participants | 97 Participants |
| Race/Ethnicity, Customized Native american | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 1 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Pacific islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 34 Participants | 15 Participants | 9 Participants | 10 Participants |
| Sex: Female, Male Male | 363 Participants | 118 Participants | 123 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 133 | 0 / 132 | 0 / 132 |
| other Total, other adverse events | 10 / 133 | 13 / 132 | 10 / 132 |
| serious Total, serious adverse events | 12 / 133 | 7 / 132 | 7 / 132 |
Outcome results
Primary
Number of Participants Who Reported Adverse Events
Time frame: From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Population: Safety Set consisted of all participants that received study drug in the core study (CACZ885H2361 \[NCT01356602\]) and had at least one post-baseline safety assessment. The patients with more than one treatment are counted in the Safety Set under those treatment groups as the actual treatments they received. Thus, the number of subjects in the treatment arms are more than the number of randomized subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Who Reported Adverse Events | 78 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Who Reported Adverse Events | 65 Participants |
| Triamcinolone Acetonide | Number of Participants Who Reported Adverse Events | 64 Participants |
Secondary
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
Time frame: Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose
Population: MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 9 days post-dose | -63.1 units on a scale | Standard Deviation 23.93 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 4 days post-dose | -55.7 units on a scale | Standard Deviation 26.91 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 6 hours post-dose | -12.9 units on a scale | Standard Deviation 21.03 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | Baseline | 74.2 units on a scale | Standard Deviation 14.52 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 5 days post-dose | -59.1 units on a scale | Standard Deviation 25.99 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 12 days post-dose | -63.3 units on a scale | Standard Deviation 26.09 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 8 days post-dose | -59.9 units on a scale | Standard Deviation 25.73 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 6 days post-dose | -61.2 units on a scale | Standard Deviation 25.14 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 24 hours post-dose | -34.9 units on a scale | Standard Deviation 24.88 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 7 days post-dose | -62.1 units on a scale | Standard Deviation 25.09 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 14 days post-dose | -64.8 units on a scale | Standard Deviation 24.66 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 11 days post-dose | -62.7 units on a scale | Standard Deviation 25.19 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 48 hours post-dose | -46.4 units on a scale | Standard Deviation 25.31 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 13 days post-dose | -65.6 units on a scale | Standard Deviation 23.25 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 10 days post-dose | -63.0 units on a scale | Standard Deviation 23.89 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 72 hours post-dose | -55.1 units on a scale | Standard Deviation 26.97 |
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 12 hours post-dose | -23.7 units on a scale | Standard Deviation 22.94 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 8 days post-dose | -60.7 units on a scale | Standard Deviation 24.07 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | Baseline | 75.5 units on a scale | Standard Deviation 14.32 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 6 hours post-dose | -13.0 units on a scale | Standard Deviation 17.14 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 12 hours post-dose | -26.7 units on a scale | Standard Deviation 22.09 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 24 hours post-dose | -36.1 units on a scale | Standard Deviation 24.55 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 48 hours post-dose | -43.8 units on a scale | Standard Deviation 24.71 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 72 hours post-dose | -45.8 units on a scale | Standard Deviation 28.74 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 4 days post-dose | -50.0 units on a scale | Standard Deviation 26.39 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 5 days post-dose | -54.3 units on a scale | Standard Deviation 25.43 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 6 days post-dose | -57.0 units on a scale | Standard Deviation 24.27 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 7 days post-dose | -59.2 units on a scale | Standard Deviation 24.32 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 9 days post-dose | -61.1 units on a scale | Standard Deviation 24.34 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 10 days post-dose | -63.3 units on a scale | Standard Deviation 24.31 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 11 days post-dose | -64.3 units on a scale | Standard Deviation 23.53 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 12 days post-dose | -64.3 units on a scale | Standard Deviation 23.91 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 13 days post-dose | -64.0 units on a scale | Standard Deviation 24.47 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 14 days post-dose | -64.8 units on a scale | Standard Deviation 24.15 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 6 hours post-dose | -10.2 units on a scale | Standard Deviation 15.78 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 9 days post-dose | -66.7 units on a scale | Standard Deviation 23.21 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 48 hours post-dose | -51.1 units on a scale | Standard Deviation 26.34 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 14 days post-dose | -69.8 units on a scale | Standard Deviation 21.25 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 10 days post-dose | -67.9 units on a scale | Standard Deviation 22.79 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 24 hours post-dose | -35.6 units on a scale | Standard Deviation 27.09 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 13 days post-dose | -69.6 units on a scale | Standard Deviation 20.67 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 11 days post-dose | -68.7 units on a scale | Standard Deviation 22.04 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 12 hours post-dose | -23.4 units on a scale | Standard Deviation 19.87 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | Baseline | 74.3 units on a scale | Standard Deviation 14.44 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 6 days post-dose | -66.0 units on a scale | Standard Deviation 23.37 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 12 days post-dose | -69.4 units on a scale | Standard Deviation 20.89 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 7 days post-dose | -66.6 units on a scale | Standard Deviation 22.21 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 5 days post-dose | -65.2 units on a scale | Standard Deviation 23.78 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 4 days post-dose | -62.0 units on a scale | Standard Deviation 23.86 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 8 days post-dose | -66.8 units on a scale | Standard Deviation 22.83 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | 72 hours post-dose | -54.7 units on a scale | Standard Deviation 30.41 |
Secondary
Change From Baseline in Pain Intensity on a 5-point Likert Scale
A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days.
Time frame: Baseline, upto 14 days post-dose
Population: Modified Analysis Set (MAS) consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Change From Baseline in Pain Intensity on a 5-point Likert Scale | -2.5 units on a scale | Standard Deviation 0.86 |
| Canakinumab, Lyophilizate (LYO) | Change From Baseline in Pain Intensity on a 5-point Likert Scale | -2.3 units on a scale | Standard Deviation 0.97 |
| Triamcinolone Acetonide | Change From Baseline in Pain Intensity on a 5-point Likert Scale | -2.7 units on a scale | Standard Deviation 0.83 |
Secondary
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Tenderness was measured on a 0-3 point scale: no pain, participant states that there is pain, participant states there is pain and winces and participant states there is pain, winces and withdraws on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable.
Time frame: Baseline, 7 days post-dose
Population: MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure and at specific category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema 7 days post-dose: Absent | 51 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: Palpable | 9 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: No Pain | 42 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema 7 days post-dose: Present | 4 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: Visible | 2 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: Pain, winces and withdraws | 26 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: No Pain | 0 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: Bulging beyond the joint margins | 12 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: Pain and winces | 17 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: Pain | 14 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: No swelling | 1 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: Bulging beyond the joint margins | 0 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: Visible | 35 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: Pain, winces and withdraws | 0 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema Baseline: Absent | 10 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: Palpable | 8 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: Pain, winces | 0 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema Baseline: Present | 46 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: No swelling | 46 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: Pain | 14 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: Pain, winces | 1 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: No swelling | 42 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: Palpable | 4 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: Visible | 2 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: Bulging beyond the joint margins | 1 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema Baseline: Absent | 13 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema Baseline: Present | 35 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema 7 days post-dose: Absent | 47 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema 7 days post-dose: Present | 2 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: No Pain | 0 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: Pain | 6 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: Pain and winces | 17 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: Pain, winces and withdraws | 26 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: No Pain | 36 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: Pain | 12 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: Bulging beyond the joint margins | 13 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: Pain, winces and withdraws | 0 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: No swelling | 2 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: Palpable | 9 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: Visible | 25 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: No Pain | 27 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema Baseline: Present | 35 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: Visible | 27 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: Pain | 16 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema Baseline: Absent | 15 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: Palpable | 4 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: Pain, winces | 5 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: Bulging beyond the joint margins | 1 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: No swelling | 38 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness 7 days post-dose: Pain, winces and withdraws | 1 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: Visible | 7 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: Pain | 14 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: No Pain | 0 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: Bulging beyond the joint margins | 15 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: Pain and winces | 20 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema 7 days post-dose: Present | 5 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling Baseline: No swelling | 4 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness Baseline: Pain, winces and withdraws | 16 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Erythema 7 days post-dose: Absent | 44 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Swelling 7 days post-dose: Palpable | 3 Participants |
Secondary
Number of Participants Responded for Physician's Global Assessment of Response to Treatment
The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor.
Time frame: 7 days post-dose
Population: MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Fair | 5 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Good | 9 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Poor | 1 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Very good | 38 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Very poor | 0 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Very good | 33 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Good | 14 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Fair | 2 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Poor | 0 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Very poor | 0 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Poor | 1 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Good | 13 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Very good | 32 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Fair | 2 Participants |
| Triamcinolone Acetonide | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | Very poor | 0 Participants |
Secondary
Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment
Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor).
Time frame: 48 weeks post-dose
Population: MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Slight | 3 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Acceptable | 2 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Excellent | 50 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Good | 17 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Poor | 0 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Acceptable | 1 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Excellent | 11 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Good | 4 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Slight | 0 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Poor | 0 Participants |
| Triamcinolone Acetonide | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Poor | 1 Participants |
| Triamcinolone Acetonide | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Slight | 1 Participants |
| Triamcinolone Acetonide | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Excellent | 11 Participants |
| Triamcinolone Acetonide | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Acceptable | 5 Participants |
| Triamcinolone Acetonide | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Good | 7 Participants |
Secondary
Number of Participant With New Flares
The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered.
Time frame: up to 36 weeks
Population: FAS consisted of all participants randomized in the core study (CACZ885H2361 \[NCT01356602\]) that had taken at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participant With New Flares | One new flare | 35 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participant With New Flares | Two new flares | 17 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participant With New Flares | Three new flares | 2 Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Number of Participant With New Flares | Greater (>) than three new flares | 4 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participant With New Flares | Greater (>) than three new flares | 1 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participant With New Flares | One new flare | 46 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participant With New Flares | Three new flares | 0 Participants |
| Canakinumab, Lyophilizate (LYO) | Number of Participant With New Flares | Two new flares | 7 Participants |
| Triamcinolone Acetonide | Number of Participant With New Flares | Greater (>) than three new flares | 3 Participants |
| Triamcinolone Acetonide | Number of Participant With New Flares | Two new flares | 26 Participants |
| Triamcinolone Acetonide | Number of Participant With New Flares | Three new flares | 8 Participants |
| Triamcinolone Acetonide | Number of Participant With New Flares | One new flare | 36 Participants |
Secondary
Probability of New Gout Flares at End of Study
The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates.
Time frame: Up to Day 337
Population: Full Analysis Set (FAS) consisted of all participants randomized in the core study (CACZ885H2361 \[NCT01356602\]) that had taken at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Probability of New Gout Flares at End of Study | 65.50 Probability |
| Canakinumab, Lyophilizate (LYO) | Probability of New Gout Flares at End of Study | 75.42 Probability |
| Triamcinolone Acetonide | Probability of New Gout Flares at End of Study | 72.95 Probability |