<br>        Core Study:<br><br>        Inclusion criteria:<br><br>          -  Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the<br>             classification of acute arthritis of primary gout<br><br>          -  Onset of current acute gout flare within 5 days prior to study entry<br><br>          -  Baseline pain intensity = 50 mm on the 0-100 mm visual analog scale (VAS)<br><br>          -  History of = 3 gout flares within the 12 months prior to study entry<br><br>          -  Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory<br>             drugs (NSAIDs) and/or colchicine<br><br>        Exclusion criteria:<br><br>          -  Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other<br>             acute inflammatory arthritis<br><br>          -  Presence of severe renal function impairment<br><br>          -  Use of specified pain relief medications or biologics ( corticosteroids, narcotics,<br>             paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis<br>             factor inhibitor) within specified periods prior to study entry<br><br>          -  Live vaccinations within 3 months prior to randomization<br><br>          -  Requirement for administration of antibiotics against latent tuberculosis (TB)<br><br>          -  Refractory heart failure (Stage D)<br><br>          -  Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia<br><br>          -  Any active or recurrent bacterial, fungal, or viral infection<br><br>        Extension Study 1:<br><br>        Inclusion Completion of the Core study. A patient was defined as completing the core study<br>        if they completed the study up to and including visit 7.<br><br>        Exclusion<br><br>        - Continuation in this extension study was considered inappropriate by the treating<br>        physician.<br><br>        Extension Study 2:<br><br>        Inclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as<br>        completing the first extension study if they completed the study up to and including Visit<br>        10).<br><br>        Exclusion<br><br>        -Continuation in this extension study was considered inappropriate by the treating<br>        physician<br><br>        Other protocol-defined inclusion-exclusion criteria applied to the core and extension<br>        studies.<br>      ;<br>        Core Study:<br><br>        Inclusion criteria:<br><br>          -  Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the<br>             classification of acute arthritis of primary gout<br><br>          -  Onset of current acute gout flare within 5 days prior to study entry<br><br>          -  Baseline pain intensity = 50 mm on the 0-100 mm visual analog scale (VAS)<br><br>          -  History of = 3 gout flares within the 12 months prior to study entry<br><br>          -  Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory<br>             drugs (NSAIDs) and/or colchicine<br><br>        Exclusion criteria:<br><br>          -  Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other<br>             acute inflammatory arthritis<br><br>          -  Presence of severe renal function impairment<br><br>          -  Use of specified pain relief medications or biologics ( corticosteroids, narcotics,<br>             paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis<br>             factor inhibitor) within specified periods prior to study entry<br><br>          -  Live vaccinations within 3 months prior to randomization<br><br>          -  Requirement for administration of antibiotics against latent tuberculosis (TB)<br><br>          -  Refractory heart failure (Stage D)<br><br>          -  Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia<br><br>          -  Any active or recurrent bacterial, fungal, or viral infection<br><br>        Extension Study 1:<br><br>        Inclusion Completion of the Core study. A patient was defined as completing the core study<br>        if they completed the study up to and including visit 7.<br><br>        Exclusion<br><br>        - Continuation in this extension study was considered inappropriate by the treating<br>        physician.<br><br>        Extension Study 2:<br><br>        Inclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as<br>        completing the first extension study if they completed the study up to and including Visit<br>        10).<br><br>        Exclusion<br><br>        -Continuation in this extension study was considered inappropriate by the treating<br>        physician<br><br>        Other protocol-defined inclusion-exclusion criteria applied to the core and extension<br>        studies.<br>      ;<br>        Core Study:<br><br>        Inclusion criteria:<br><br>          -  Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the<br>             classification of acute arthritis of primary gout<br><br>          -  Onset of current acute gout flare within 5 days prior to study entry<br><br>          -  Baseline pain intensity = 50 mm on the 0-100 mm visual analog scale (VAS)<br><br>          -  History of = 3 gout flares within the 12 months prior to study entry<br><br>          -  Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory<br>             drugs (NSAIDs) and/or colchicine<br><br>        Exclusion criteria:<br><br>          -  Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other<br>             acute inflammatory arthritis<br><br>          -  Presence of severe renal function impairment<br><br>          -  Use of specified pain relief medications or biologics ( corticosteroids, narcotics,<br>             paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis<br>             factor inhibitor) within specified periods prior to study entry<br><br>          -  Live vaccinations within 3 months prior to randomization<br><br>          -  Requirement for administration of antibiotics against latent tuberculosis (TB)<br><br>          -  Refractory heart failure (Stage D)<br><br>          -  Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia<br><br>          -  Any active or recurrent bacterial, fungal, or viral infection<br><br>        Extension Study 1:<br><br>        Inclusion Completion of the Core study. A patient was defined as completing the core study<br>        if they completed the study up to and including visit 7.<br><br>        Exclusion<br><br>        - Continuation in this extension study was considered inappropriate by the treating<br>        physician.<br><br>        Extension Study 2:<br><br>        Inclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as<br>        completing the first extension study if they completed the study up to and including Visit<br>        10).<br><br>        Exclusion<br><br>        -Continuation in this extension study was considered inappropriate by the treating<br>        physician<br><br>        Other protocol-defined inclusion-exclusion criteria applied to the core and extension<br>        studies.<br>      ;<br>        Core Study:<br><br>        Inclusion criteria:<br><br>          -  Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the<br>             classification of acute arthritis of primary gout<br><br>          -  Onset of current acute gout flare within 5 days prior to study entry<br><br>          -  Baseline pain intensity = 50 mm on the 0-100 mm visual analog scale (VAS)<br><br>          -  History of = 3 gout flares within the 12 months prior to study entry<br><br>          -  Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory<br>             drugs (NSAIDs) and/or colchicine<br><br>        Exclusion criteria:<br><br>          -  Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other<br>             acute inflammatory arthritis<br><br>          -  Presence of severe renal function impairment<br><br>          -  Use of specified pain relief medications or biologics ( corticosteroids, narcotics,<br>             paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis<br>             factor inhibitor) within specified periods prior to study entry<br><br>          -  Live vaccinations within 3 months prior to randomization<br><br>          -  Requirement for administration of antibiotics against latent tuberculosis (TB)<br><br>          -  Refractory heart failure (Stage D)<br><br>          -  Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia<br><br>          -  Any active or recurrent bacterial, fungal, or viral infection<br><br>        Extension Study 1:<br><br>        Inclusion Completion of the Core study. A patient was defined as completing the core study<br>        if they completed the study up to and including visit 7.<br><br>        Exclusion<br><br>        - Continuation in this extension study was considered inappropriate by the treating<br>        physician.<br><br>        Extension Study 2:<br><br>        Inclusion Completed of the first extension study CACZ885H2356E1. A patient was defined as<br>        completing the first extension study if they completed the study up to and including Visit<br>        10).<br><br>        Exclusion<br><br>        -Continuation in this extension study was considered inappropriate by the treating<br>        physician<br><br>        Other protocol-defined inclusion-exclusion criteria applied to the core and extension<br>        studies.<br>