Acute Gouty Arthritis
Conditions
Keywords
Gout, arthritis, gout flare, acute gout, gouty, rheumatic disease, uric acid
Brief summary
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
Interventions
DRUGCanakinumab pre-filled syringe
Canakinumab pre-filled syringe
DRUGCanakinumab lyophilized powder
Canakinumab lyophilized powder
DRUGTriamcinolone Acetonide
Triamcinolone Acetonide
DRUGPlacebo
Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 3 or more gout flares within last year * Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine * Body mass index of less than or equal to 45 kg/m2
Exclusion criteria
* Use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine. * Hemodialysis * Live vaccine within 3 months before first dose * Donation or loss of 400 mL or more within 3 months before first dose * Gout brought on by other factors such as chemotherapy, lead, transplant, etc. * Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis * Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions * Significant cardiovascular conditions such as uncontrolled hypertension * Significant medical diseases such as uncontrolled diabetes, thyroid disease * History of malignancy of any organ system within the past 5 years * Women who are pregnant or nursing * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups | 72 hours post dose | The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Assessment of Pain Intensity on a 0-100mm VAS | 14 days | The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days. |
| Patient's Assessment of Pain Intensity on a 5-point Likert Scale | 72 hours | A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days. |
| Number of Patients With at Least One New Gouty Arthritis Flare After Baseline | 12 weeks | Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. |
| Time to the First New Gouty Arthritis Flare | 12 weeks | Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated. |
| Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS | 14 days | The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported. |
| Time to Resolution of Gouty Arthritis Flare as Reported by Patient | 14 days | Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported. |
| Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | 72 hours | A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale. |
| Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | 72 hours | A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor). |
| Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups | 72 hours post dose | The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method. |
| Physician's Assessment of Swelling | 72 hours | The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. |
| Physician's Assessment of Erythema | 72 hours | The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable. |
| Physician's Assessment of Range of Motion of the Most Affected Joint | 72 hours | The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized). |
| Proportion of Patients With Rescue Medication Intake | 12 weeks | Patients used a diary to record the time of intake of rescue medication and the amount taken. |
| Time to First Rescue Medication Intake | 14 days | Patients used a diary to record the time of intake of rescue medication and the amount taken. |
| Amount of Rescue Medication Taken (mg) | 14 days | Patients used a diary to record the time of intake of rescue medication and the amount taken. |
| C-reactive Protein Level | 72 hours | A central laboratory was used for analysis of all blood samples collected. |
| Physician's Assessment of Tenderness | 72 hours | The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that there is pain, 2 = patient states there is pain and winces and 3 = patient states there is pain, winces and withdraws on palpation or passive movement of the affected study joint. |
Countries
Canada, Germany, Hungary, Lithuania, United States
Participant flow
Pre-assignment details
Number of subjects randomized was 397. Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to a safety set of 399 subjects. Subjects who did not receive study drug were excluded from analysis.
Participants by arm
| Arm | Count |
|---|---|
| Canakinumab, Pre-filled Syringes (PFS) Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug. | 133 |
| Canakinumab, Lyophilizate (LYO) The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug. | 133 |
| Triamcinolone Acetonide The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug. | 133 |
| Total | 399 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative Problems | 1 | 4 | 5 |
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 4 |
| Overall Study | Lost to Follow-up | 4 | 5 | 6 |
| Overall Study | Protocol Deviation | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 | 7 |
Baseline characteristics
| Characteristic | Canakinumab, Pre-filled Syringes (PFS) | Canakinumab, Lyophilizate (LYO) | Triamcinolone Acetonide | Total |
|---|---|---|---|---|
| Age, Continuous | 53.4 Years STANDARD_DEVIATION 11.21 | 53 Years STANDARD_DEVIATION 11.84 | 53.7 Years STANDARD_DEVIATION 11.33 | 53.5 Years STANDARD_DEVIATION 11.44 |
| Sex: Female, Male Female | 15 Participants | 9 Participants | 11 Participants | 35 Participants |
| Sex: Female, Male Male | 118 Participants | 124 Participants | 122 Participants | 364 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 133 | 0 / 133 | 0 / 133 |
| serious Total, serious adverse events | 6 / 133 | 6 / 133 | 5 / 133 |
Outcome results
Primary
Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
Time frame: 72 hours post dose
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups | 17.1 Millimeters | Standard Error 2.04 |
| Triamcinolone Acetonide | Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups | 32 Millimeters | Standard Error 2.08 |
Secondary
Amount of Rescue Medication Taken (mg)
Patients used a diary to record the time of intake of rescue medication and the amount taken.
Time frame: 14 days
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Amount of Rescue Medication Taken (mg) | Codeine | 12.7 milligrams (mg) | Standard Deviation 55.3 |
| Canakinumab, Pre-filled Syringes (PFS) | Amount of Rescue Medication Taken (mg) | Acetaminophen | 609.2 milligrams (mg) | Standard Deviation 1800.06 |
| Canakinumab, Pre-filled Syringes (PFS) | Amount of Rescue Medication Taken (mg) | Prednisolone / Prednisone | 5.8 milligrams (mg) | Standard Deviation 23.13 |
| Canakinumab, Lyophilizate (LYO) | Amount of Rescue Medication Taken (mg) | Codeine | 23.9 milligrams (mg) | Standard Deviation 124.56 |
| Canakinumab, Lyophilizate (LYO) | Amount of Rescue Medication Taken (mg) | Acetaminophen | 1108.3 milligrams (mg) | Standard Deviation 2821.54 |
| Canakinumab, Lyophilizate (LYO) | Amount of Rescue Medication Taken (mg) | Prednisolone / Prednisone | 6.7 milligrams (mg) | Standard Deviation 25.09 |
| Triamcinolone Acetonide | Amount of Rescue Medication Taken (mg) | Acetaminophen | 2323.1 milligrams (mg) | Standard Deviation 5580.82 |
| Triamcinolone Acetonide | Amount of Rescue Medication Taken (mg) | Prednisolone / Prednisone | 24.7 milligrams (mg) | Standard Deviation 53.2 |
| Triamcinolone Acetonide | Amount of Rescue Medication Taken (mg) | Codeine | 60.8 milligrams (mg) | Standard Deviation 191.2 |
Secondary
C-reactive Protein Level
A central laboratory was used for analysis of all blood samples collected.
Time frame: 72 hours
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | C-reactive Protein Level | 3.65 mg / L |
| Canakinumab, Lyophilizate (LYO) | C-reactive Protein Level | 3.37 mg / L |
| Triamcinolone Acetonide | C-reactive Protein Level | 5.2 mg / L |
Secondary
Number of Patients With at Least One New Gouty Arthritis Flare After Baseline
Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.
Time frame: 12 weeks
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Number of Patients With at Least One New Gouty Arthritis Flare After Baseline | 12 Particpants |
| Canakinumab, Lyophilizate (LYO) | Number of Patients With at Least One New Gouty Arthritis Flare After Baseline | 12 Particpants |
| Triamcinolone Acetonide | Number of Patients With at Least One New Gouty Arthritis Flare After Baseline | 52 Particpants |
Secondary
Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
Time frame: 72 hours post dose
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups | 17.1 Millimeters | Standard Error 2.04 |
| Canakinumab, Lyophilizate (LYO) | Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups | 19.7 Millimeters | Standard Error 2.05 |
Secondary
Patient's Assessment of Pain Intensity on a 0-100mm VAS
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.
Time frame: 14 days
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Assessment of Pain Intensity on a 0-100mm VAS | 7.9 Millimeters | Standard Error 1.69 |
| Canakinumab, Lyophilizate (LYO) | Patient's Assessment of Pain Intensity on a 0-100mm VAS | 8.2 Millimeters | Standard Error 1.7 |
| Triamcinolone Acetonide | Patient's Assessment of Pain Intensity on a 0-100mm VAS | 14.8 Millimeters | Standard Error 1.72 |
Secondary
Patient's Assessment of 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. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.
Time frame: 72 hours
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | None | 35.9 Percentage of Patients |
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Extreme | 0.8 Percentage of Patients |
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Mild | 45.8 Percentage of Patients |
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Severe | 2.3 Percentage of Patients |
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Moderate | 15.3 Percentage of Patients |
| Canakinumab, Lyophilizate (LYO) | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Mild | 44.2 Percentage of Patients |
| Canakinumab, Lyophilizate (LYO) | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Severe | 1.6 Percentage of Patients |
| Canakinumab, Lyophilizate (LYO) | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Extreme | 0 Percentage of Patients |
| Canakinumab, Lyophilizate (LYO) | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Moderate | 21.7 Percentage of Patients |
| Canakinumab, Lyophilizate (LYO) | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | None | 32.6 Percentage of Patients |
| Triamcinolone Acetonide | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Severe | 14.1 Percentage of Patients |
| Triamcinolone Acetonide | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Mild | 36.7 Percentage of Patients |
| Triamcinolone Acetonide | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | None | 23.4 Percentage of Patients |
| Triamcinolone Acetonide | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Moderate | 21.9 Percentage of Patients |
| Triamcinolone Acetonide | Patient's Assessment of Pain Intensity on a 5-point Likert Scale | Extreme | 3.9 Percentage of Patients |
Secondary
Patient's Global Assessment of Response to Treatment 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. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.
Time frame: 72 hours
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Slight | 6.4 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Acceptable | 10.4 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Excellent | 36.0 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Good | 43.2 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Poor | 4.0 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Acceptable | 20.0 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Excellent | 34.8 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Good | 36.5 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Slight | 7.8 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Poor | 0.9 Percentage of Participants |
| Triamcinolone Acetonide | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Poor | 12.4 Percentage of Participants |
| Triamcinolone Acetonide | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Slight | 14.2 Percentage of Participants |
| Triamcinolone Acetonide | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Excellent | 20.4 Percentage of Participants |
| Triamcinolone Acetonide | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Acceptable | 21.2 Percentage of Participants |
| Triamcinolone Acetonide | Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale | Good | 31.9 Percentage of Participants |
Secondary
Physician's Assessment of Erythema
The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.
Time frame: 72 hours
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Erythema | Absent | 88.3 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Erythema | Present | 11.7 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Erythema | Absent | 82.9 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Erythema | Present | 17.1 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Erythema | Present | 31.4 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Erythema | Absent | 68.6 Percentage of Participants |
Secondary
Physician's Assessment of Range of Motion of the Most Affected Joint
The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).
Time frame: 72 hours
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Range of Motion of the Most Affected Joint | Moderately restricted | 11.5 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Range of Motion of the Most Affected Joint | Severely restricted | 0.8 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Range of Motion of the Most Affected Joint | Normal | 50.0 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Range of Motion of the Most Affected Joint | Mildly restricted | 37.7 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Range of Motion of the Most Affected Joint | Immobilized | 0.0 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Range of Motion of the Most Affected Joint | Normal | 44.8 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Range of Motion of the Most Affected Joint | Immobilized | 0.0 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Range of Motion of the Most Affected Joint | Mildly restricted | 40.8 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Range of Motion of the Most Affected Joint | Severely restricted | 2.4 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Range of Motion of the Most Affected Joint | Moderately restricted | 12.0 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Range of Motion of the Most Affected Joint | Severely restricted | 12.4 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Range of Motion of the Most Affected Joint | Normal | 35.5 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Range of Motion of the Most Affected Joint | Immobilized | 0.8 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Range of Motion of the Most Affected Joint | Moderately restricted | 14.0 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Range of Motion of the Most Affected Joint | Mildly restricted | 37.2 Percentage of Participants |
Secondary
Physician's Assessment of Swelling
The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.
Time frame: 72 hours
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Swelling | Bulging beyond the joint margins | 1.5 Percentage of Partipants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Swelling | Visible | 10.8 Percentage of Partipants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Swelling | Palpable | 26.9 Percentage of Partipants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Swelling | No swelling | 60.8 Percentage of Partipants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Swelling | Palpable | 25.6 Percentage of Partipants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Swelling | Bulging beyond the joint margins | 1.6 Percentage of Partipants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Swelling | No swelling | 55.2 Percentage of Partipants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Swelling | Visible | 17.6 Percentage of Partipants |
| Triamcinolone Acetonide | Physician's Assessment of Swelling | Bulging beyond the joint margins | 8.3 Percentage of Partipants |
| Triamcinolone Acetonide | Physician's Assessment of Swelling | No swelling | 51.2 Percentage of Partipants |
| Triamcinolone Acetonide | Physician's Assessment of Swelling | Visible | 24.8 Percentage of Partipants |
| Triamcinolone Acetonide | Physician's Assessment of Swelling | Palpable | 15.7 Percentage of Partipants |
Secondary
Physician's Assessment of Tenderness
The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that there is pain, 2 = patient states there is pain and winces and 3 = patient states there is pain, winces and withdraws on palpation or passive movement of the affected study joint.
Time frame: 72 hours
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Tenderness | No pain | 50.0 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Tenderness | There is pain | 43.1 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Tenderness | There is pain and winces | 5.4 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Assessment of Tenderness | There is pain, winces and withdraws | 1.5 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Tenderness | There is pain, winces and withdraws | 0.8 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Tenderness | No pain | 40.0 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Tenderness | There is pain and winces | 6.4 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Assessment of Tenderness | There is pain | 52.8 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Tenderness | There is pain, winces and withdraws | 9.1 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Tenderness | There is pain | 47.1 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Tenderness | There is pain and winces | 14.0 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Assessment of Tenderness | No pain | 29.8 Percentage of Participants |
Secondary
Physician's Global Assessment of Response to Treatment 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. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).
Time frame: 72 hours
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Very poor | 1.5 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Very good | 46.2 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Good | 35.4 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Fair | 15.4 Percentage of Participants |
| Canakinumab, Pre-filled Syringes (PFS) | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Poor | 1.5 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Very good | 33.6 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Very poor | 0.0 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Poor | 1.6 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Fair | 16.0 Percentage of Participants |
| Canakinumab, Lyophilizate (LYO) | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Good | 48.8 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Very poor | 7.4 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Fair | 23.1 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Very good | 21.5 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Good | 33.9 Percentage of Participants |
| Triamcinolone Acetonide | Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale | Poor | 14.0 Percentage of Participants |
Secondary
Proportion of Patients With Rescue Medication Intake
Patients used a diary to record the time of intake of rescue medication and the amount taken.
Time frame: 12 weeks
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Proportion of Patients With Rescue Medication Intake | 29.0 Percentage of Particpants |
| Canakinumab, Lyophilizate (LYO) | Proportion of Patients With Rescue Medication Intake | 31.8 Percentage of Particpants |
| Triamcinolone Acetonide | Proportion of Patients With Rescue Medication Intake | 45.7 Percentage of Particpants |
Secondary
Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.
Time frame: 14 days
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS | 24 Hours |
| Canakinumab, Lyophilizate (LYO) | Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS | 25 Hours |
| Triamcinolone Acetonide | Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS | 48 Hours |
Secondary
Time to First Rescue Medication Intake
Patients used a diary to record the time of intake of rescue medication and the amount taken.
Time frame: 14 days
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Time to First Rescue Medication Intake | 11 Hours | Full Range 61.87 |
| Canakinumab, Lyophilizate (LYO) | Time to First Rescue Medication Intake | 7.5 Hours | Full Range 31.59 |
| Triamcinolone Acetonide | Time to First Rescue Medication Intake | 11 Hours | Full Range 39.06 |
Secondary
Time to Resolution of Gouty Arthritis Flare as Reported by Patient
Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.
Time frame: 14 days
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Time to Resolution of Gouty Arthritis Flare as Reported by Patient | 142 Hours |
| Canakinumab, Lyophilizate (LYO) | Time to Resolution of Gouty Arthritis Flare as Reported by Patient | 120 Hours |
| Triamcinolone Acetonide | Time to Resolution of Gouty Arthritis Flare as Reported by Patient | 170 Hours |
Secondary
Time to the First New Gouty Arthritis Flare
Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
Time frame: 12 weeks
Population: Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Canakinumab, Pre-filled Syringes (PFS) | Time to the First New Gouty Arthritis Flare | NA Days |
| Canakinumab, Lyophilizate (LYO) | Time to the First New Gouty Arthritis Flare | NA Days |
| Triamcinolone Acetonide | Time to the First New Gouty Arthritis Flare | NA Days |