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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)

Primary Purpose

Acute Gout

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Canakinumab 150 mg

Triamcinolone acetonide 40 mg

Placebo to canakinumab

Placebo to triamcinolone acetonide

About this trial

This is an interventional treatment trial for Acute Gout focused on measuring Frequent flares, Gout, Anti-interleukin-1β monoclonal antibody

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Canakinumab 150 mg

Triamcinolone acetonide 40 mg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to First New Flare: Survival Analysis During the 12 Weeks of Study

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

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

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)

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)

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

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

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

The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.

Pharmacokinetic Concentrations

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)

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)

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

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

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

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

Amount of Rescue Medication Taken

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

Full Information

NCT ID

NCT01080131

First Posted

March 2, 2010

Last Updated

December 24, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01080131

Brief Title

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.

Acronym

β-RELIEVED-II

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Gout

Keywords

Frequent flares, Gout, Anti-interleukin-1β monoclonal antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

226 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Canakinumab 150 mg

Arm Type

Experimental

Arm Description

Arm Title

Triamcinolone acetonide 40 mg

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Canakinumab 150 mg

Intervention Description

Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).

Intervention Type

Drug

Intervention Name(s)

Triamcinolone acetonide 40 mg

Intervention Description

Triamcinolone acetonide 40 mg was supplied as a suspension.

Intervention Type

Drug

Intervention Name(s)

Placebo to canakinumab

Intervention Description

Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.

Intervention Type

Drug

Intervention Name(s)

Placebo to triamcinolone acetonide

Intervention Description

Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.

Primary Outcome Measure Information:

Title

Time to First New Flare: Survival Analysis During the 12 Weeks of Study

Description

Time Frame

Baseline to 12 weeks

Title

Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose

Description

Time Frame

72 hours post-dose (randomization)

Title

Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks

Description

Time Frame

During 24 weeks overall

Title

Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)

Description

Time Frame

72 weeks

Secondary Outcome Measure Information:

Title

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)

Description

Time Frame

Baseline to 7 days post-dose (randomization)

Title

Time to Complete Resolution of Pain; Survival Analysis

Description

Time Frame

Baseline to 7 days post-dose (randomization)

Title

SF 36 Physical Function Score at Week 12

Description

Time Frame

Week 12

Title

Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study

Description

The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.

Time Frame

Baseline to Week 12

Title

Pharmacokinetic Concentrations

Description

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.

Time Frame

12 weeks post-dose

Title

Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS)

Description

Time Frame

6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)

Title

Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS)

Description

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).

Title

Time to the First New Gout Flare During 24 Weeks

Description

Time Frame

From randomization to the end of the first extension period (24 weeks).

Title

Mean Number of New Gout Flares Per Patient During 24 Weeks

Description

Time Frame

24 weeks

Title

Time to First Intake of Rescue Medication

Description

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).

Title

Percentage of Participants Who Took Rescue Medication

Description

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).

Title

Amount of Rescue Medication Taken

Description

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).

Title

Physician's Global Assessment of Response to Treatment

Description

Time Frame

72 hours post-dose and 24-weeks post-dose.

Title

Patient's Global Assessment of Response to Treatment

Description

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.

Time Frame

72 hours post-dose and 24 weeks post-dose

Title

Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint

Description

Time Frame

72 hours post-dose and 24 weeks post-dose

Title

Physician's Assessment of Range of Motion of the Most Affected Joint

Description

Time Frame

72 hours post-dose and 24 weeks post-dose

Title

High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels

Description

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).

Title

Patient's Assessment of Gout Pain Intensity in the Most Affected Joint

Description

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).

Time Frame

72 hours post-dose and 24 weeks post-dose

Title

Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme

Description

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).

Title

Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks

Description

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.

Time Frame

From randomization to the end of the second extension period (72 weeks).

Title

Flare Rate Per Year

Description

Time Frame

From randomization to the end of the second extension period (72 weeks).

Title

Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab

Description

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.

Title

Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab

Description

Time Frame

Title

Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab

Description

Time Frame

Title

Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab

Description

Time Frame

Title

Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab

Description

Time Frame

Title

Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab

Description

Time Frame

Title

High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab

Description

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.

Title

Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab

Description

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Pinnacle Research Group, LLC

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Novartis Investigative site

City

Foley

State/Province

Alabama

ZIP/Postal Code

36535

Country

United States

Facility Name

Horizon Research Group, Inc.

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Sun Valley Arthritis Center, Ltd

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Genova Clinical Research

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

Little Rock Diagnostic Clinic

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Providence Research

City

Burbank

State/Province

California

ZIP/Postal Code

91505

Country

United States

Facility Name

Diagnamics, Inc.

City

Carlsbad

State/Province

California

ZIP/Postal Code

92008

Country

United States

Facility Name

Med Investigations

City

Fair Oaks

State/Province

California

ZIP/Postal Code

95628

Country

United States

Facility Name

Valerius Medical Group and Research Center of Long Branch

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Lucita M. Cruz, M.D., Inc.

City

Norwalk

State/Province

California

ZIP/Postal Code

90650

Country

United States

Facility Name

Sierra Clinical Research

City

Orangevale

State/Province

California

ZIP/Postal Code

95662

Country

United States

Facility Name

Chaparral Medical Grp, INC Clinical Research

City

Pomona

State/Province

California

ZIP/Postal Code

91767

Country

United States

Facility Name

River City Clinical Research

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Arthritis Associates

City

San Antonio

State/Province

California

ZIP/Postal Code

782209

Country

United States

Facility Name

California Research Foundation

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Rochester clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Ritchken and First MDs

City

San Diego

State/Province

California

ZIP/Postal Code

92117

Country

United States

Facility Name

Huntington Medical Foundation

City

San Marino

State/Province

California

ZIP/Postal Code

91108

Country

United States

Facility Name

Crest Clinical Trials

City

Santa Ana

State/Province

California

ZIP/Postal Code

92701

Country

United States

Facility Name

Orange County Research Center

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Progressive Clinical Research

City

Vista

State/Province

California

ZIP/Postal Code

92803

Country

United States

Facility Name

Center for Clinical Trials of San Gabriel

City

West Covina

State/Province

California

ZIP/Postal Code

91790

Country

United States

Facility Name

Clinical Res Ct of CT - Arthritis Associates of CT/NY, LLC

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Innovative Research of West Florida

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Health Awareness

City

Jupiter

State/Province

Florida

ZIP/Postal Code

33458

Country

United States

Facility Name

Pines Research, LLC Pembroke Clinical Trials

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

DMI Healthcare Group, Inc.

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33782

Country

United States

Facility Name

Tampa Medical Group, P.A.

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

RST DAta Research

City

Conyers

State/Province

Georgia

ZIP/Postal Code

30012

Country

United States

Facility Name

Q Clinical Research

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30035

Country

United States

Facility Name

Harbin Clinic

City

Rome

State/Province

Georgia

ZIP/Postal Code

30165

Country

United States

Facility Name

Sonora Clinical Research, LLC

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Northwest Clinical Trials

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

The Arthritis Center

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Deaconess Clinic

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

Pinnacle Medical Research

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Wichita Clinic

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

Dolby Research, LLC

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

Gulf Coast Research, LLC

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70508

Country

United States

Facility Name

Clinical Trials Management

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Arthritis and Diabetes Clinic

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

Regional Research Specialists

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71106

Country

United States

Facility Name

The Family Doctors

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71115

Country

United States

Facility Name

Center for Rheumatology & Bone Research

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

MASS Research, LLC

City

Waltham

State/Province

Massachusetts

ZIP/Postal Code

02453

Country

United States

Facility Name

Clarkston Medical Group

City

Clarkston

State/Province

Michigan

ZIP/Postal Code

48346

Country

United States

Facility Name

L Kage Healthcare Services

City

Flint

State/Province

Michigan

ZIP/Postal Code

48532

Country

United States

Facility Name

West Michigan Rheumatology

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Facility Name

*Private Practice*

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Oakland Medical Research Center

City

Troy

State/Province

Michigan

ZIP/Postal Code

48085

Country

United States

Facility Name

Arthritis Associates of Mississippi

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

CRC of Jackson

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Phillips Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39209

Country

United States

Facility Name

Montana Medical Research

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

Quality Clinical Research

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Heartland Clinical Research, Inc.

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Clinical Research Advantage, Inc

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

Arthritis and Osteoporosis Associates

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

UMDNJ Robert Wood Johnson Medical School

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

Facility Name

Arthritis and Osteoporosis Medical Association

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

Andrew J. Porges, MD, PC

City

Roslyn

State/Province

New York

ZIP/Postal Code

11576

Country

United States

Facility Name

Metrolina Medical Research

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

The Center For Nutrition and Preventive Medicine

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Unifour Medical Research Associates

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Jones Family Practice, PA

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

Columbia Arthritis Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

STAT Research, Inc.

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Ohio Clinical Research, LLC

City

Willoughby Hills

State/Province

Ohio

ZIP/Postal Code

44094

Country

United States

Facility Name

Humility of Mary Health Partners DBA St. Elizabeth Health Ce

City

Youngstown

State/Province

Ohio

ZIP/Postal Code

44501

Country

United States

Facility Name

Health Research of Oklahoma, PLLC

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Health Research Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73109

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Philadelphia VA medical Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Partners in Clinical Research

City

Bumberland

State/Province

Rhode Island

ZIP/Postal Code

02864

Country

United States

Facility Name

Medical Research South

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Pharmacorp Clinical Trials, INC

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29412

Country

United States

Facility Name

Tlm Medical Services Llc

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Palmetto Clinical Trial Services, LLC

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

Community Research Partners, Inc.

City

Varnville

State/Province

South Carolina

ZIP/Postal Code

29924

Country

United States

Facility Name

Community Research Partners, Inc.

City

Varnville

State/Province

South Carolina

ZIP/Postal Code

29944

Country

United States

Facility Name

Tri-Cities Medical Research

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Alpha Clinical Research

City

Clarksville

State/Province

Tennessee

ZIP/Postal Code

37403

Country

United States

Facility Name

The Jackson Clinic

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38301

Country

United States

Facility Name

The Arthritis Clinic

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

MultiSpecialty Clinical Research

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37601

Country

United States

Facility Name

Lovelace Scientific Resource

City

Austin

State/Province

Texas

ZIP/Postal Code

78758

Country

United States

Facility Name

Rheumatic Disease Clinical Research Center, Llc

City

Houston

State/Province

Texas

ZIP/Postal Code

77004

Country

United States

Facility Name

R/D Clinical Research, Inc.

City

Lake Jackson

State/Province

Texas

ZIP/Postal Code

77566

Country

United States

Facility Name

Leander Healthcare Center

City

Leander

State/Province

Texas

ZIP/Postal Code

78641

Country

United States

Facility Name

Accurate Clinical Research

City

Nassau Bay

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

North Hills Family Practice

City

North Richard Hills

State/Province

Texas

ZIP/Postal Code

76180

Country

United States

Facility Name

Arthritis Center South Texas

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78232

Country

United States

Facility Name

Novartis Investigative site

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

Health Research of Hampton Roads

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Novartis Investigative Site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

Novartis Investigative Site

City

St-John's

State/Province

Newfoundland and Labrador

Country

Canada

Facility Name

Novartis Investigative site

City

Sainte Foy

State/Province

Quebec

Country

Canada

Facility Name

Novartis Investigative Site

City

Kaohsiung Hsien

State/Province

Taiwan

Country

China

Facility Name

Novartis Investigative Site

City

Kaohsiung

State/Province

Taiwan

Country

China

Facility Name

Novartis Investigative Site

City

Taichung

State/Province

Taiwan

Country

China

Facility Name

Novartis Investigative Site

City

Taipei

State/Province

Taiwan

Country

China

Facility Name

Novartis Investigative Site

City

Enschede

Country

Netherlands

Facility Name

Novartis Investigative site

City

Leeuwarden

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Moscow

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yekaterinburg

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

24122883

Citation

Chakraborty A, Van LM, Skerjanec A, Floch D, Klein UR, Krammer G, Sunkara G, Howard D. Pharmacokinetic and pharmacodynamic properties of canakinumab in patients with gouty arthritis. J Clin Pharmacol. 2013 Dec;53(12):1240-51. doi: 10.1002/jcph.162. Epub 2013 Sep 30.

Results Reference

derived

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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)

Acute Gout

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial