Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

The Number of Patients With at Least 1 New Gout Flare

Time frame: 12 weeks

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)

Time frame: baseline through 12 weeks

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).

Time frame: baseline through week 12

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).

Time frame: 72 hours through week 12

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).

Time frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose

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).

Time frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose

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).

Time frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose

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).

Time frame: baseline through week 12

Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment

Kaplan Meier estimate

Time frame: 12 weeks

Time to Complete Resolution of Pain: Survival Analysis by Treatment

Kaplan Meier estimate

Time frame: 12 weeks

Time to First Rescue Medication Intake

Time frame: 12 weeks

Percent Patients Who Took Rescue Medication

Time frame: 12 weeks

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.

Time frame: 12 weeks

High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose

Time frame: 72 hours post dose