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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 Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study (β-RELIEVED)

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, intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAIDs) 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 Completed of the first extension study CACZ885H2356E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).

Exclusion

-Continuation in this 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

Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive re-dose of study drug on demand upon occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after previous dose. Patients completing 12 weeks core study were allowed to continue treatment in another 12-week extension for any new gout flare on demand with same treatment as assigned in core study. After completing the first extension, patients were offered to enter second extension study, whereby all patients were treated open-label "on demand" with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in core study. Patients completing first 12 weeks extension study were allowed to continue to be treated in another single-arm, open-label 48 weeks extension when all patients from both treatment arms received canakinumab on demand

Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients 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. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period Triamcinolone acetonide was not to be administered in the 48-week session.

Outcomes

Primary Outcome Measures

Time to First New Flare

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 (0-100mm 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), at 72 hours 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.

Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)

This was the primary endpoint of both extension studies. 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. 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 (AE), Death and Serious Adverse Events (72 Weeks Overall)

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 (0-100mm VAS)

The Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at baseline was determined along with the 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

Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. 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. The Kaplan-Meier estimates of time to complete resolution of self-assessed pain intensity in the joint most affected and their confidence intervals were determined.

Percentage of Participants With Complete Resolution of Pain

Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). 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. Complete Resolution of Pain is defined as no pain (None) on the Likert Scale. The Kaplan-Meier estimates of cumulative event rate = percentage of participants with event up to the end of the time interval.

Percentage of Participants With at Least 1 New Gout Flare During the 12 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. Patients did not meet criterion of having new gout flare if: · Increasing/renewed gout pain in an affected joint before the flare has resolved completely.

Mean Number of New Gout Flares Per Patient

SF36 Physical Function Score at Week 12

The SF-36 measures the impact of disease on overall quality of life (QoL). This 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 an 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. A negative change score indicates improvement. An ANCOVA model was used with treatment group and baseline SF-36 physical function subscore as covariates.

Time to First New Flare

Kaplan-Meier (KM) estimates of time to first new flare and confidence intervals were determined. 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 the flare has resolved completely.

Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study

Time to First Intake of Rescue Medication After the Last Post Baseline Flare.

The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.

Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension

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). 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.

Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)

Maximum severity is the maximum Likert score recorded after the start of the flare. 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). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme).

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 prednisolon 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.

Percentage of Participants Who Took Rescue Medication

Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments. Permitted rescue medications included acetaminophen 500 mg and/ or codeine 30 mg as needed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as needed per day for 2 days followed by up to 20 mg of prednisolone as needed per day for 3 subsequent days within 7 days after randomization or after re-dose/injection administration.

High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall

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. Analytes 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.

Physician's Global Assessment of Response to Treatment

Patient's Global Assessment of Response to Treatment

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 patients 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 patients in each category is reported.

Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)

Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)

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. 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 the flare has resolved completely.

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

High sensitivity C-reactive protein (hsCRP) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.

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

Serum Amyloid A Protein (SAA) levels were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analytes were measured by a central laboratory. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.

Physician's Global Assessment of Response to Treatment for Patients 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, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's assessments (pain intensity [Visual Analog Scale and Likert scale] and patient's global assessment of response to treatment). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.

Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)

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). It participant had a new flare, they also scored the maximum amount of acute gout pain in the most affected joint since the onset of a new flare on 5 point Likert scale (none, mild, moderate, severe, extreme). The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.

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

Patients made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. Percentage of participants in each category for both core and extension periods were measured. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.

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

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; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.

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

The study physician assessed the most affected joint for: Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.

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

The study physician assessed the most affected joint for Erythema: Present or absent. The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.

Full Information

NCT ID

NCT01029652

First Posted

December 9, 2009

Last Updated

December 24, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01029652

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 Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study

Acronym

β-RELIEVED

Official Title

A 12 Weeks Randomized, Controlled Core 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-week Double-blind Extension Study and an Open-label 48 Week Extension Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (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 the 12-week core 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 CACZ885H2356. The purpose of the second 48 week open-label extension study was to collect additional long-term safety and tolerability data in patients who have completed the first extension study CACZ885H2356E1.

Detailed Description

Masking: Core: Double Blind (Subject, Investigator) Extension 1: Double Blind (Subject, Investigator) Extension 2: Open-label, terminated

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

230 (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

Description

Time Frame

12 weeks

Title

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

Description

Time Frame

72 hours post-dose (randomization)

Title

Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)

Description

Time Frame

24 weeks overall

Title

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

Description

Time Frame

72 weeks overall

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 (0-100mm VAS)

Description

Time Frame

From baseline to 7 days post dose (randomization)

Title

Time to Complete Resolution of Pain

Description

Time Frame

7 days post-dose (randomization)

Title

Percentage of Participants With Complete Resolution of Pain

Description

Time Frame

7 days post-dose (randomization)

Title

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

Description

Time Frame

12 weeks

Title

Mean Number of New Gout Flares Per Patient

Description

Time Frame

12 weeks

Title

SF36 Physical Function Score at Week 12

Description

Time Frame

Week 12

Title

Time to First New Flare

Description

Time Frame

24 weeks

Title

Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study

Description

Time Frame

24 weeks

Title

Time to First Intake of Rescue Medication After the Last Post Baseline Flare.

Description

The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.

Time Frame

72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Title

Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension

Description

Time Frame

72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Title

Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)

Description

Time Frame

Last post-baseline flare (during 24 weeks overall)

Title

Amount of Rescue Medication Taken

Description

Time Frame

7 days last post-baseline flare (during 24 weeks)

Title

Percentage of Participants Who Took Rescue Medication

Description

Time Frame

during 12 weeks core, 24 weeks overall

Title

High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall

Description

Time Frame

72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Title

Physician's Global Assessment of Response to Treatment

Description

Time Frame

72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Title

Patient's Global Assessment of Response to Treatment

Description

Time Frame

72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Title

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

Description

Time Frame

72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)

Title

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

Description

Time Frame

72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (24 weeks overall)

Title

Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)

Description

Time Frame

7 days post dose (randomization), 24 weeks post-dose

Title

Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)

Description

Time Frame

72 weeks overall

Title

Flare Rate Per Year

Description

Time Frame

72 weeks overall

Title

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

Description

Time Frame

24 hours, 72 hours, 7 days, 4 weeks, 8 weeks and 12 weeks post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)

Title

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

Description

Time Frame

Title

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

Description

Time Frame

72 hours post-dose , 7 days post-dose for the last post-baseline flare for patients re-treated with canakinumab or first post-baseline flare treated with canakinumab for patients switched treatment (during 72 weeks overall)

Title

Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)

Description

Time Frame

72 hours post-dose , 7 days post dose for the last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

Title

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

Description

Time Frame

Title

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

Description

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; The percentage of patients in each category is reported. The treatment effect reported for canakinumab arm was for last post-baseline flare after re-treated with canakinumab and for patient which switched to Canakinumab arm was for first post-baseline flare after receiving the first dose of canakinumab.

Time Frame

72 hours post-dose , 7 days post dose last post-baseline flare for patients re-treated with canakinumab or the first post-baseline flare treated with canakinumab for patients who switched treatment (during 72 weeks overall)

Title

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

Description

Time Frame

Title

Physician's Assessment of Erythema for Patients Re-treated 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, intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAIDs) 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 Completed of the first extension study CACZ885H2356E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10). Exclusion -Continuation in this 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

Novartis Investigative Site

City

Darlinghurst

State/Province

New South Wales

Country

Australia

Facility Name

Novartis Investigative Site

City

Fitzroy

State/Province

Victoria

Country

Australia

Facility Name

Novartis Investigative Site

City

Heidelberg

State/Province

Victoria

Country

Australia

Facility Name

Novartis Investigative Site

City

Daw Park SA

Country

Australia

Facility Name

Novartis Investigative site

City

Gozee

Country

Belgium

Facility Name

Novartis Investigative Site

City

Mount Pearl

State/Province

Newfoundland and Labrador

Country

Canada

Facility Name

Novartis Investigative site

City

St-John's

State/Province

Newfoundland and Labrador

Country

Canada

Facility Name

Novartis Investigative site

City

Hamilton

State/Province

Ontario

Country

Canada

Facility Name

Novartis Investigative site

City

Barranquilla

Country

Colombia

Facility Name

Novartis Investigative site

City

Bogota

Country

Colombia

Facility Name

Novartis Investigative site

City

Bucaramanga

Country

Colombia

Facility Name

Novartis Investigative site

City

Parnu

Country

Estonia

Facility Name

Novartis Investigative site

City

Tallinn

Country

Estonia

Facility Name

Novartis Investigative site

City

Tartu

Country

Estonia

Facility Name

Novartis Investigative Site

City

Bayreuth

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

Country

Germany

Facility Name

Novartis Investigative Site

City

Loehne

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

Country

Germany

Facility Name

Novartis Investigative site

City

Munich

Country

Germany

Facility Name

Novartis Investigative Site

City

Guatemala City

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Riga

Country

Latvia

Facility Name

Novartis Investigative Site

City

Valmiera

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kedainiai

Country

Lithuania

Facility Name

Novartis Investigative site

City

Klaipeda

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Siauliai

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

Country

Lithuania

Facility Name

Novartis Investigative site

City

Culiacan

Country

Mexico

Facility Name

Novartis Investigative site

City

Guadalajara

Country

Mexico

Facility Name

Novartis Investigative site

City

Mexicali

Country

Mexico

Facility Name

Novartis Investigative site

City

Oslo

Country

Norway

Facility Name

Novartis Investigative site

City

Katowice

Country

Poland

Facility Name

Novartis Investigative site

City

Kutno

Country

Poland

Facility Name

Novartis Investigative site

City

Lublin

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

Country

Poland

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

Facility Name

Novartis Investigative site

City

Singapore

Country

Singapore

Facility Name

Novartis Investigative Site

City

Goeteborg

Country

Sweden

Facility Name

Novartis Investigative site

City

Stockholm

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lausanne

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Donetsk

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kyiv

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Lviv

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Zaporizhzhya

Country

Ukraine

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 Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study (β-RELIEVED)

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