Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study. (β-RELIEVED-II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01080131
First received: March 2, 2010
Last updated: December 24, 2013
Last verified: April 2013
  Purpose

The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide.

The purpose of the first 12 week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2357.

The purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.


Condition Intervention Phase
Acute Gout
Drug: Canakinumab 150 mg
Drug: Triamcinolone acetonide 40 mg
Drug: Placebo to canakinumab
Drug: Placebo to triamcinolone acetonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective Including a 12 Weeks Extension Study and a 1 Year Open-label Extension Study

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Time to First New Flare: Survival Analysis During the 12 Weeks of Study [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely.

  • Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose [ Time Frame: 72 hours post-dose (randomization) ] [ Designated as safety issue: No ]
    Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.

  • Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks [ Time Frame: During 24 weeks overall ] [ Designated as safety issue: Yes ]
    This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

  • Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall) [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
    This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.


Secondary Outcome Measures:
  • Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) [ Time Frame: Baseline to 7 days post-dose (randomization) ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm 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. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.

  • Time to Complete Resolution of Pain; Survival Analysis [ Time Frame: Baseline to 7 days post-dose (randomization) ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.

  • SF 36 Physical Function Score at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.

  • Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.

  • Pharmacokinetic Concentrations [ Time Frame: 12 weeks post-dose ] [ Designated as safety issue: No ]
    Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL.

  • Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS) [ Time Frame: 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization) ] [ Designated as safety issue: No ]
    Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.

  • Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS) [ Time Frame: 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks). ] [ Designated as safety issue: No ]
    Patient's assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates.

  • Time to the First New Gout Flare During 24 Weeks [ Time Frame: From randomization to the end of the first extension period (24 weeks). ] [ Designated as safety issue: No ]

    Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had:

    • Flare in joint, not a previously affected joint (at baseline or during study)
    • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

    Participants 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.


  • Mean Number of New Gout Flares Per Patient During 24 Weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Patients met definition of new flare if they had:

    • Flare in joint, not a previously affected joint(at baseline or during study)
    • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

    Participants 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 First Intake of Rescue Medication [ Time Frame: For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks). ] [ Designated as safety issue: No ]

    Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:

    • Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
    • If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.

    Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.

    Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks).


  • Percentage of Participants Who Took Rescue Medication [ Time Frame: For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks). ] [ Designated as safety issue: No ]

    Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:

    • Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
    • If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.

    Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.


  • Amount of Rescue Medication Taken [ Time Frame: For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks). ] [ Designated as safety issue: No ]

    Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows:

    • Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed.
    • If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.

  • Physician's Global Assessment of Response to Treatment [ Time Frame: 72 hours post-dose and 24-weeks post-dose. ] [ Designated as safety issue: No ]
    The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's own assessments (pain intensity and patient's global assessment of response to treatment).

  • Patient's Global Assessment of Response to Treatment [ Time Frame: 72 hours post-dose and 24 weeks post-dose ] [ Designated as safety issue: No ]
    Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported.

  • Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint [ Time Frame: 72 hours post-dose and 24 weeks post-dose ] [ Designated as safety issue: No ]
    The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that "there is pain", patient states "there is pain and winces", and patient states "there is pain, winces, and withdraws" on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported.

  • Physician's Assessment of Range of Motion of the Most Affected Joint [ Time Frame: 72 hours post-dose and 24 weeks post-dose ] [ Designated as safety issue: No ]
    The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported.

  • High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels [ Time Frame: 72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks). ] [ Designated as safety issue: No ]
    High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.

  • Patient's Assessment of Gout Pain Intensity in the Most Affected Joint [ Time Frame: 72 hours post-dose and 24 weeks post-dose ] [ Designated as safety issue: No ]
    Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme).

  • Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme [ Time Frame: From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks). ] [ Designated as safety issue: No ]
    For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period.

  • Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks [ Time Frame: From randomization to the end of the second extension period (72 weeks). ] [ Designated as safety issue: No ]

    Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1).

    Patients met definition of new flare if they had:

    • Flare in joint, not a previously affected joint (at baseline or during study)
    • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

    Patients did not meet criterion of having new gout flare if:

    • Increasing/renewed gout pain in an affected joint before flare has resolved completely.


  • Flare Rate Per Year [ Time Frame: From randomization to the end of the second extension period (72 weeks). ] [ Designated as safety issue: No ]

    Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab.

    Participants met the definition of new flare if they had:

    • Flare in joint, not a previously affected joint (at baseline or during study)
    • Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely.

    Participants did not meet criterion of having new gout flare if:

    • Increasing/renewed gout pain in an affected joint before the flare has resolved completely.

    Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate.


  • Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab [ Time Frame: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. ] [ Designated as safety issue: No ]

    Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme).

    Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.


  • Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab [ Time Frame: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. ] [ Designated as safety issue: No ]
    Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.

  • Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab [ Time Frame: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. ] [ Designated as safety issue: No ]

    The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor.

    The physician completed the physician's global assessment of response to treatment without viewing any of the patient's assessments.

    Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.


  • Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab [ Time Frame: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. ] [ Designated as safety issue: No ]

    The study physician assessed the most affected joint for tenderness on the following 4-point scale:

    • no pain;
    • participant states that "there is pain;
    • participant states "there is pain and winces";
    • participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.

    Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.


  • Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab [ Time Frame: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. ] [ Designated as safety issue: No ]

    The study physician assessed the most affected joint for swelling on the following 4-point scale:

    • no swelling;
    • palpable;
    • visible;
    • bulging beyond the joint margins.

    Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.


  • Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab [ Time Frame: 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. ] [ Designated as safety issue: No ]

    The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable.

    Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.


  • High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab [ Time Frame: 24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. ] [ Designated as safety issue: No ]

    High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.

    Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.


  • Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab [ Time Frame: 24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. ] [ Designated as safety issue: No ]

    Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment.

    Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.



Enrollment: 226
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canakinumab 150 mg

Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Participants completing the 12 week core study could continue to be treated in a 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months.

Drug: Canakinumab 150 mg
Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).
Drug: Placebo to triamcinolone acetonide
Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.
Active Comparator: Triamcinolone acetonide 40 mg

Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Participants completing the 12 week core study could continue to be treated in a 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.

In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year. Triamcinolone acetonide was not to be administered in the second extension study.

Drug: Triamcinolone acetonide 40 mg
Triamcinolone acetonide 40 mg was supplied as a suspension.
Drug: Placebo to canakinumab
Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Core Study:

Inclusion criteria:

  • Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout
  • Onset of current acute gout flare within 5 days prior to study entry
  • Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
  • History of ≥ 3 gout flares within the 12 months prior to study entry
  • Contraindication, or intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAID) and/or colchicine

Exclusion criteria:

  • Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
  • Presence of severe renal function impairment
  • Use of specified pain relief medications or biologics (corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor within specified periods prior to study entry
  • Live vaccinations within 3 months prior to randomization
  • Requirement for administration of antibiotics against latent tuberculosis (TB)
  • Refractory heart failure (Stage D)
  • Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
  • Any active or recurrent bacterial, fungal, or viral infection

Extension Study 1:

Inclusion:

- Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7.

Exclusion:

- Continuation in this extension study was considered inappropriate by the treating physician.

Extension Study 2:

Inclusion Criteria:

  • Completion of the first extension study CACZ885H2357E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).

Exclusion Criteria:

-Continuation in this second extension study was considered inappropriate by the treating physician.

Other protocol-defined inclusion-exclusion criteria applied to the core and extension studies.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080131

  Hide Study Locations
Locations
United States, Alabama
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Novartis Investigative site
Foley, Alabama, United States, 36535
Horizon Research Group, Inc.
Mobile, Alabama, United States, 36608
United States, Arizona
Sun Valley Arthritis Center, Ltd
Peoria, Arizona, United States, 85381
Genova Clinical Research
Tucson, Arizona, United States, 85741
United States, Arkansas
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States, 72205
United States, California
Providence Research
Burbank, California, United States, 91505
Diagnamics, Inc.
Carlsbad, California, United States, 92008
Med Investigations
Fair Oaks, California, United States, 95628
Valerius Medical Group and Research Center of Long Branch
Long Beach, California, United States, 90806
Lucita M. Cruz, M.D., Inc.
Norwalk, California, United States, 90650
Sierra Clinical Research
Orangevale, California, United States, 95662
Chaparral Medical Grp, INC Clinical Research
Pomona, California, United States, 91767
River City Clinical Research
Sacramento, California, United States, 95816
Arthritis Associates
San Antonio, California, United States, 782209
California Research Foundation
San Diego, California, United States, 92103
Ritchken and First MDs
San Diego, California, United States, 92117
Rochester clinical Research
San Diego, California, United States, 92108
Huntington Medical Foundation
San Marino, California, United States, 91108
Crest Clinical Trials
Santa Ana, California, United States, 92701
Orange County Research Center
Tustin, California, United States, 92780
Progressive Clinical Research
Vista, California, United States, 92803
Center for Clinical Trials of San Gabriel
West Covina, California, United States, 91790
United States, Connecticut
Clinical Res Ct of CT - Arthritis Associates of CT/NY, LLC
Danbury, Connecticut, United States, 06810
United States, Florida
Innovative Research of West Florida
Clearwater, Florida, United States, 33756
Health Awareness
Jupiter, Florida, United States, 33458
Pines Research, LLC Pembroke Clinical Trials
Pembroke Pines, Florida, United States, 33028
DMI Healthcare Group, Inc.
Pinellas Park, Florida, United States, 33782
Tampa Medical Group, P.A.
Tampa, Florida, United States, 33614
United States, Georgia
RST DAta Research
Conyers, Georgia, United States, 30012
Q Clinical Research
Decatur, Georgia, United States, 30035
Harbin Clinic
Rome, Georgia, United States, 30165
United States, Idaho
Sonora Clinical Research, LLC
Boise, Idaho, United States, 83702
Northwest Clinical Trials
Boise, Idaho, United States, 83704
United States, Illinois
The Arthritis Center
Springfield, Illinois, United States, 62704
United States, Indiana
Deaconess Clinic
Evansville, Indiana, United States, 47713
United States, Kansas
Pinnacle Medical Research
Overland Park, Kansas, United States, 66215
Wichita Clinic
Wichita, Kansas, United States, 67208
United States, Louisiana
Dolby Research, LLC
Baton Rouge, Louisiana, United States, 70809
Gulf Coast Research, LLC
Lafayette, Louisiana, United States, 70508
Clinical Trials Management
Metairie, Louisiana, United States, 70006
Arthritis and Diabetes Clinic
Monroe, Louisiana, United States, 71203
The Family Doctors
Shreveport, Louisiana, United States, 71115
Regional Research Specialists
Shreveport, Louisiana, United States, 71106
United States, Maryland
Center for Rheumatology & Bone Research
Wheaton, Maryland, United States, 20902
United States, Massachusetts
MASS Research, LLC
Waltham, Massachusetts, United States, 02453
United States, Michigan
Clarkston Medical Group
Clarkston, Michigan, United States, 48346
L Kage Healthcare Services
Flint, Michigan, United States, 48532
West Michigan Rheumatology
Grand Rapids, Michigan, United States, 49546
*Private Practice*
Lansing, Michigan, United States, 48910
Oakland Medical Research Center
Troy, Michigan, United States, 48085
United States, Mississippi
Arthritis Associates of Mississippi
Jackson, Mississippi, United States, 39202
CRC of Jackson
Jackson, Mississippi, United States, 39202
Phillips Medical Center
Jackson, Mississippi, United States, 39209
United States, Montana
Montana Medical Research
Missoula, Montana, United States, 59808
United States, Nebraska
Quality Clinical Research
Omaha, Nebraska, United States, 68114
Heartland Clinical Research, Inc.
Omaha, Nebraska, United States, 68134
United States, Nevada
Clinical Research Advantage, Inc
Henderson, Nevada, United States, 89014
United States, New Jersey
Arthritis and Osteoporosis Associates
Freehold, New Jersey, United States, 07728
UMDNJ Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, New York
Arthritis and Osteoporosis Medical Association
Brooklyn, New York, United States, 11201
Andrew J. Porges, MD, PC
Roslyn, New York, United States, 11576
United States, North Carolina
The Center For Nutrition and Preventive Medicine
Charlotte, North Carolina, United States, 28277
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
Unifour Medical Research Associates
Hickory, North Carolina, United States, 28601
Jones Family Practice, PA
Shelby, North Carolina, United States, 28150
United States, Ohio
Columbia Arthritis Center
Columbus, Ohio, United States, 43215
STAT Research, Inc.
Dayton, Ohio, United States, 45417
Ohio Clinical Research, LLC
Willoughby Hills, Ohio, United States, 44094
Humility of Mary Health Partners DBA St. Elizabeth Health Ce
Youngstown, Ohio, United States, 44501
United States, Oklahoma
Health Research of Oklahoma, PLLC
Oklahoma City, Oklahoma, United States, 73103
Health Research Institute
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Philadelphia VA medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Partners in Clinical Research
Bumberland, Rhode Island, United States, 02864
United States, South Carolina
Pharmacorp Clinical Trials, INC
Charleston, South Carolina, United States, 29412
Medical Research South
Charleston, South Carolina, United States, 29407
Tlm Medical Services Llc
Columbia, South Carolina, United States, 29204
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States, 29601
Community Research Partners, Inc.
Varnville, South Carolina, United States, 29924
Community Research Partners, Inc.
Varnville, South Carolina, United States, 29944
United States, Tennessee
Tri-Cities Medical Research
Bristol, Tennessee, United States, 37620
Alpha Clinical Research
Clarksville, Tennessee, United States, 37403
The Jackson Clinic
Jackson, Tennessee, United States, 38301
The Arthritis Clinic
Jackson, Tennessee, United States, 38305
MultiSpecialty Clinical Research
Johnson City, Tennessee, United States, 37601
United States, Texas
Lovelace Scientific Resource
Austin, Texas, United States, 78758
Rheumatic Disease Clinical Research Center, Llc
Houston, Texas, United States, 77004
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
Leander Healthcare Center
Leander, Texas, United States, 78641
Accurate Clinical Research
Nassau Bay, Texas, United States, 77058
North Hills Family Practice
North Richard Hills, Texas, United States, 76180
Arthritis Center South Texas
San Antonio, Texas, United States, 78232
United States, Virginia
Novartis Investigative site
Danville, Virginia, United States, 24541
Health Research of Hampton Roads
Newport News, Virginia, United States, 23606
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada
Canada, Newfoundland and Labrador
Novartis Investigative Site
St-John's, Newfoundland and Labrador, Canada
Canada, Quebec
Novartis Investigative site
Sainte Foy, Quebec, Canada
China, Taiwan
Novartis Investigative Site
Kaohsiung, Taiwan, China
Novartis Investigative Site
Kaohsiung Hsien, Taiwan, China
Novartis Investigative Site
Taichung, Taiwan, China
Novartis Investigative Site
Taipei, Taiwan, China
Netherlands
Novartis Investigative Site
Enschede, Netherlands
Novartis Investigative site
Leeuwarden, Netherlands
Russian Federation
Novartis Investigative Site
Moscow, Russian Federation
Novartis Investigative Site
Yaroslavl, Russian Federation
Novartis Investigative Site
Yekaterinburg, Russian Federation
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01080131     History of Changes
Obsolete Identifiers: NCT01137344, NCT01194921
Other Study ID Numbers: CACZ885H2357, 2010-018913-32, CACZ885H2357E1
Study First Received: March 2, 2010
Results First Received: August 30, 2011
Last Updated: December 24, 2013
Health Authority: Canada: Health Canada
Netherlands: Dutch Health Care Inspectorate
Russia: Pharmacological Committee, Ministry of Health
United States: Food and Drug Administration
Taiwan: Taiwan Food and Drug Administration

Keywords provided by Novartis:
Frequent flares
Gout
Anti-interleukin-1β monoclonal antibody

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Triamcinolone
Triamcinolone Acetonide
Anti-Inflammatory Agents, Non-Steroidal
Antibodies, Monoclonal
Colchicine
Triamcinolone diacetate
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Immunologic Factors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014