| Primary | The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS) | A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) | | Posted | | Least Squares Mean | Standard Error | units on a scale | | at 72 hours post-dose | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00018.2± 3.03
- OG00137.9± 3.03
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANCOVA | | <0.0001 | | Mean Difference (Final Values) | -19.69 | | | 2-Sided | 95 | -28.2 | -11.2 | | | | | Superiority or Other | | |
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| Primary | Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis | Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks | | Posted | | Number | 95% Confidence Interval | Participants | | 12 weeks | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | The Number of Patients With at Least 1 New Gout Flare | | | Posted | | Number | | participants | | 12 weeks | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment | A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) | | Posted | | Mean | Standard Deviation | unit on a scale | | baseline through 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment | Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). | | Posted | | Number | | participants | | baseline through week 12 | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale. | Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done). | | Posted | | Number | | participants | | 72 hours through week 12 | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment | Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed). | | Posted | | Number | | participants | | baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment | Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed). | | Posted | | Number | | participants | | baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment | Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable). | | Posted | | Number | | participants | | baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment | Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized). | | Posted | | Number | | participants | | baseline through week 12 | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment | | | Posted | | Median | 95% Confidence Interval | hours | | 12 weeks | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Time to Complete Resolution of Pain: Survival Analysis by Treatment | | | Posted | | Median | 95% Confidence Interval | hours | | 12 weeks | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Time to First Rescue Medication Intake | | | Posted | | Mean | Standard Deviation | hours | | 12 weeks | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Percent Patients Who Took Rescue Medication | | | Posted | | Number | | percentage | | 12 weeks | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare. | Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare. | | Posted | | Mean | Standard Deviation | mg | | 12 weeks | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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| Secondary | High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose | | | Posted | | Mean | 95% Confidence Interval | mg/L | | 72 hours post dose | | | | ID | Title | Description |
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| OG000 | ACZ885 150 mg | Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m. | | OG001 | Triamcinolone Acetonide 40 mg | triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c. |
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