Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01071213
Registration number
NCT01071213
Ethics application status
Date submitted
9/12/2009
Date registered
10/12/2009
Date last updated
30/01/2014
Titles & IDs
Public 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
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2009-015018-23
Query!
Secondary ID [2]
0
0
CACZ885H2356
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ß-RELIEVED
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Acute Gout
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Canakinumab 150 mg
Treatment: Drugs - Triamcinolone acetonide 40 mg
Treatment: Drugs - Placebo to canakinumab
Treatment: Drugs - Placebo to triamcinolone acetonide
Treatment: Drugs - Placebo
Treatment: Drugs - SAM-531 1.5 mg
Treatment: Drugs - SAM-531 3.0 mg
Treatment: Drugs - SAM-531 5.0 mg
Treatment: Drugs - Donepezil
Placebo comparator: 1 - Placebo
Experimental: Canakinumab 150 mg - 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
Active comparator: Triamcinolone acetonide 40 mg - 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.
Experimental: 2 - SAM-531 1.5 mg
Experimental: 3 - SAM-531 3.0 mg
Experimental: 4 - SAM-531 5.0 mg
Active comparator: 5 - Donepezil
Treatment: Drugs: Canakinumab 150 mg
Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).
Treatment: Drugs: Triamcinolone acetonide 40 mg
Triamcinolone acetonide 40 mg was supplied as a suspension.
Treatment: Drugs: Placebo to canakinumab
Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.
Treatment: Drugs: Placebo to triamcinolone acetonide
Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.
Treatment: Drugs: Placebo
Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.
Treatment: Drugs: SAM-531 1.5 mg
Capsules SAM-531 1.5 mg, once a day during 52 weeks.
Treatment: Drugs: SAM-531 3.0 mg
Capsules SAM-531 3.0 mg, once a day during 52 weeks.
Treatment: Drugs: SAM-531 5.0 mg
Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.
Treatment: Drugs: Donepezil
Encapsulated Donepezil 5 mg tablets, once a day during 52 weeks. After Day 42, the dose can up titrated up to 10 mg of Donepezil.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time to First New Flare
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12 weeks
Query!
Primary outcome [2]
0
0
Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
72 hours post-dose (randomization)
Query!
Primary outcome [3]
0
0
Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
24 weeks overall
Query!
Primary outcome [4]
0
0
Number of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
72 weeks overall
Query!
Primary outcome [5]
0
0
Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24
Query!
Assessment method [5]
0
0
14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.
Query!
Timepoint [5]
0
0
Baseline, Week 24
Query!
Secondary outcome [1]
0
0
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)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From baseline to 7 days post dose (randomization)
Query!
Secondary outcome [2]
0
0
Time to Complete Resolution of Pain
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
7 days post-dose (randomization)
Query!
Secondary outcome [3]
0
0
Percentage of Participants With Complete Resolution of Pain
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
7 days post-dose (randomization)
Query!
Secondary outcome [4]
0
0
Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
12 weeks
Query!
Secondary outcome [5]
0
0
Mean Number of New Gout Flares Per Patient
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
12 weeks
Query!
Secondary outcome [6]
0
0
SF36 Physical Function Score at Week 12
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Week 12
Query!
Secondary outcome [7]
0
0
Time to First New Flare
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
24 weeks
Query!
Secondary outcome [8]
0
0
Mean Number of New Gout Flares Per Patient During the 24 Weeks of the Study
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
24 weeks
Query!
Secondary outcome [9]
0
0
Time to First Intake of Rescue Medication After the Last Post Baseline Flare.
Query!
Assessment method [9]
0
0
The Kaplan-Meier estimates of medians and 95% confidence intervals were used to calculate the endpoint.
Query!
Timepoint [9]
0
0
72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Query!
Secondary outcome [10]
0
0
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint on a Visual Analog Scale (VAS) in Extension
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Query!
Secondary outcome [11]
0
0
Percentage of Participants With Maximum Severity of Last Post-baseline Flare (5-point Likert Scale)
Query!
Assessment method [11]
0
0
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).
Query!
Timepoint [11]
0
0
Last post-baseline flare (during 24 weeks overall)
Query!
Secondary outcome [12]
0
0
Amount of Rescue Medication Taken
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
7 days last post-baseline flare (during 24 weeks)
Query!
Secondary outcome [13]
0
0
Percentage of Participants Who Took Rescue Medication
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
during 12 weeks core, 24 weeks overall
Query!
Secondary outcome [14]
0
0
High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels for Core and 24 Weeks Overall
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Query!
Secondary outcome [15]
0
0
Physician's Global Assessment of Response to Treatment
Query!
Assessment method [15]
0
0
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).
Query!
Timepoint [15]
0
0
72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Query!
Secondary outcome [16]
0
0
Patient's Global Assessment of Response to Treatment
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Query!
Secondary outcome [17]
0
0
Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (during 24 weeks overall)
Query!
Secondary outcome [18]
0
0
Physician's Assessment of Range of Motion of the Most Affected Joint
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
72 hours post-dose (randomization), 72 hours post-dose for the last post-baseline flare (24 weeks overall)
Query!
Secondary outcome [19]
0
0
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale)
Query!
Assessment method [19]
0
0
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).
Query!
Timepoint [19]
0
0
7 days post dose (randomization), 24 weeks post-dose
Query!
Secondary outcome [20]
0
0
Time to First New Flare: Survival Analysis by Treatment (72 Weeks Overall)
Query!
Assessment method [20]
0
0
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.
Query!
Timepoint [20]
0
0
72 weeks overall
Query!
Secondary outcome [21]
0
0
Flare Rate Per Year
Query!
Assessment method [21]
0
0
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.
Query!
Timepoint [21]
0
0
72 weeks overall
Query!
Secondary outcome [22]
0
0
High-sensitivity C-reactive Protein (hsCRP) Levels for Patients Re-treated With or Switched to Canakinumab
Query!
Assessment method [22]
0
0
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.
Query!
Timepoint [22]
0
0
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)
Query!
Secondary outcome [23]
0
0
Serum Amyloid A Protein (SAA) Levels for Patients Re-treated With or Switched to Canakinumab
Query!
Assessment method [23]
0
0
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.
Query!
Timepoint [23]
0
0
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)
Query!
Secondary outcome [24]
0
0
Physician's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab
Query!
Assessment method [24]
0
0
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.
Query!
Timepoint [24]
0
0
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)
Query!
Secondary outcome [25]
0
0
Patient's Assessment of Gout Pain Intensity in the Currently Most-affected Joint (Likert Scale)
Query!
Assessment method [25]
0
0
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.
Query!
Timepoint [25]
0
0
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)
Query!
Secondary outcome [26]
0
0
Patient's Global Assessment of Response to Treatment for Patients Re-treated or Switched to Canakinumab
Query!
Assessment method [26]
0
0
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.
Query!
Timepoint [26]
0
0
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)
Query!
Secondary outcome [27]
0
0
Physician's Assessment of Joint Tenderness for Patients Re-treated or Switched to Canakinumab
Query!
Assessment method [27]
0
0
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.
Query!
Timepoint [27]
0
0
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)
Query!
Secondary outcome [28]
0
0
Physician's Assessment of Joint Swelling for Patients Re-treated or Switched to Canakinumab
Query!
Assessment method [28]
0
0
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.
Query!
Timepoint [28]
0
0
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)
Query!
Secondary outcome [29]
0
0
Physician's Assessment of Erythema for Patients Re-treated or Switched to Canakinumab
Query!
Assessment method [29]
0
0
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.
Query!
Timepoint [29]
0
0
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)
Query!
Secondary outcome [30]
0
0
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24
Query!
Assessment method [30]
0
0
Caregiver interview-based instrument assessing 10 areas of activities of daily living (ADL) to measure participant's actual performance over the previous 2 weeks. Items included hygiene, dressing, continence, eating, meal preparation, telephoning, outings, finance/correspondence, medications and leisure/housework. Responses scored as 1 (yes) or 0 (no), response of "Not Applicable" was not scored. Total DAD score was sum of scores for 40 items, expressed as a percentage of the number of items answered yes or no. Total score ranged from 0 to 100, higher scores represented less disability in ADL.
Query!
Timepoint [30]
0
0
Baseline, Week 24
Query!
Secondary outcome [31]
0
0
Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24
Query!
Assessment method [31]
0
0
Caregiver interview-based rating scale assessed 10 behavioral, 2 neurovegetative disturbances occurring in dementia: delusions, hallucination, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, appetite/eating disorders and sleep/nightime behavior disorders. Each symptom score derived by symptom frequency (1 \[occasionally\] to 4 \[very frequently\] \* symptom severity (1 \[mild\] to 3 \[severe\]) and ranged 0-12. Total score = sum of symptom scores; range 0-144, higher score indicating greater behavioral disturbances
Query!
Timepoint [31]
0
0
Baseline, Week 24
Query!
Secondary outcome [32]
0
0
Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24
Query!
Assessment method [32]
0
0
Caregiver and participant interview-based tool to rate the overall impression of participant's clinical change of the disease over time. Areas covered in the interview include: relevant history, observation/evaluation, mental/cognitive state, behavior and functioning. Change categorized into 1 of 7 categories: marked improvement, moderate improvement, minimal improvement, no change, minimal worsening, moderate worsening, marked worsening.
Query!
Timepoint [32]
0
0
Baseline, Week 24
Query!
Secondary outcome [33]
0
0
Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24
Query!
Assessment method [33]
0
0
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total Errors=total number of incorrect boxes chosen plus adjustment for estimated possible errors on problems, attempts, and recalls not reached. Total score 0 to 106, lower scores=better performance.
Query!
Timepoint [33]
0
0
Baseline, Week 24
Query!
Secondary outcome [34]
0
0
Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24
Query!
Assessment method [34]
0
0
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.
Query!
Timepoint [34]
0
0
Baseline, Week 24
Query!
Secondary outcome [35]
0
0
Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24
Query!
Assessment method [35]
0
0
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.
Query!
Timepoint [35]
0
0
Baseline, Week 24
Query!
Secondary outcome [36]
0
0
Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24
Query!
Assessment method [36]
0
0
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 4 box assessments the maximum number of errors per trial was 20. Test ended with 20 errors in a trial. Less than 20 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 39. Lower scores: better performance.
Query!
Timepoint [36]
0
0
Baseline, Week 24
Query!
Secondary outcome [37]
0
0
Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24
Query!
Assessment method [37]
0
0
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.
Query!
Timepoint [37]
0
0
Baseline, Week 24
Query!
Secondary outcome [38]
0
0
Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24
Query!
Assessment method [38]
0
0
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.
Query!
Timepoint [38]
0
0
Baseline, Week 24
Query!
Secondary outcome [39]
0
0
Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24
Query!
Assessment method [39]
0
0
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials for each assessment. Possible errors for each successful assessment: 4 box 0-38; 6 box 0-58; 8 box 0-78. Between Errors for N Boxes was the cumulative number of errors per each successful trial. Total scores ranged from 0 to 175. Lower scores indicated better performance.
Query!
Timepoint [39]
0
0
Baseline, Week 24
Query!
Secondary outcome [40]
0
0
Change From Baseline in CANTAB SWM Strategy at Week 24
Query!
Assessment method [40]
0
0
CANTAB-SWM assessed participant's ability to strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials per assessment. Strategy score was the number of unique boxes the participant searched in the two 6 and 8 box trials. 6 box trial scores ranged from 1 (1 box searched for all 6 tokens) to 6 (6 boxes searched for 6 tokens). 8 box trial score ranged from 1 (1 box searched) to 8 (8 boxes searched for 8 tokens). Total of the 4 trial scores ranged from 4 to 28. Lower score indicated better performance.
Query!
Timepoint [40]
0
0
Baseline, Week 24
Query!
Secondary outcome [41]
0
0
Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24
Query!
Assessment method [41]
0
0
CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Latency in correct responses ranged from 0 to infinity millisecond (msec), lower scores indicated better performance.
Query!
Timepoint [41]
0
0
Baseline, Week 24
Query!
Secondary outcome [42]
0
0
Change From Baseline in CANTAB PRM-Percentage Correct at Week 24
Query!
Assessment method [42]
0
0
CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.
Query!
Timepoint [42]
0
0
Baseline, Week 24
Query!
Secondary outcome [43]
0
0
Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24
Query!
Assessment method [43]
0
0
CANTAB-RTI assessed participant's reaction, movement time and vigilance during a 5-choice reaction time trial and to measure anticipatory/premature and perseverative responses. In the trial, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Accuracy was the total number of trials where participant responded correctly. Total ranged from 0 to 30, higher score indicated better performance.
Query!
Timepoint [43]
0
0
Baseline, Week 24
Query!
Secondary outcome [44]
0
0
Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24
Query!
Assessment method [44]
0
0
CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Movement Time was the time from release of press pad to screen touch where the spot had been in trials the participant responded correctly. Possible score ranged from 100 to 5100 msec, lower score indicated better performance.
Query!
Timepoint [44]
0
0
Baseline, Week 24
Query!
Secondary outcome [45]
0
0
Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24
Query!
Assessment method [45]
0
0
CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Query!
Timepoint [45]
0
0
Baseline, Week 24
Query!
Secondary outcome [46]
0
0
Change From Baseline in CANTAB RTI Simple Movement Time at Week 24
Query!
Assessment method [46]
0
0
CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Movement Time was the time from release of press pad to touch the screen where the spot had been in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Query!
Timepoint [46]
0
0
Baseline, Week 24
Query!
Secondary outcome [47]
0
0
Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24
Query!
Assessment method [47]
0
0
CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Query!
Timepoint [47]
0
0
Baseline, Week 24
Query!
Secondary outcome [48]
0
0
Percentage of Participants Who Were Responders at Week 24
Query!
Assessment method [48]
0
0
Responder defined as a participant who demonstrated an improvement of at least 3 points from baseline in the ADAS-Cog total score and no worsening in the DAD total score and in ADCS-CGIC. Participants were considered a responder at Week 24 if all 3 criteria were met.
Query!
Timepoint [48]
0
0
Week 24
Query!
Eligibility
Key inclusion 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2009
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
230
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Novartis Investigative Site - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Novartis Investigative Site - Fitzroy
Query!
Recruitment hospital [3]
0
0
Novartis Investigative Site - Heidelberg
Query!
Recruitment hospital [4]
0
0
Novartis Investigative Site - Daw Park SA
Query!
Recruitment postcode(s) [1]
0
0
- Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
- Fitzroy
Query!
Recruitment postcode(s) [3]
0
0
- Heidelberg
Query!
Recruitment postcode(s) [4]
0
0
- Daw Park SA
Query!
Recruitment outside Australia
Country [1]
0
0
Belgium
Query!
State/province [1]
0
0
Gozee
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Newfoundland and Labrador
Query!
Country [3]
0
0
Canada
Query!
State/province [3]
0
0
Ontario
Query!
Country [4]
0
0
Colombia
Query!
State/province [4]
0
0
Barranquilla
Query!
Country [5]
0
0
Colombia
Query!
State/province [5]
0
0
Bogota
Query!
Country [6]
0
0
Colombia
Query!
State/province [6]
0
0
Bucaramanga
Query!
Country [7]
0
0
Estonia
Query!
State/province [7]
0
0
Parnu
Query!
Country [8]
0
0
Estonia
Query!
State/province [8]
0
0
Tallinn
Query!
Country [9]
0
0
Estonia
Query!
State/province [9]
0
0
Tartu
Query!
Country [10]
0
0
Germany
Query!
State/province [10]
0
0
Bayreuth
Query!
Country [11]
0
0
Germany
Query!
State/province [11]
0
0
Berlin
Query!
Country [12]
0
0
Germany
Query!
State/province [12]
0
0
Leipzig
Query!
Country [13]
0
0
Germany
Query!
State/province [13]
0
0
Loehne
Query!
Country [14]
0
0
Germany
Query!
State/province [14]
0
0
Magdeburg
Query!
Country [15]
0
0
Germany
Query!
State/province [15]
0
0
Munich
Query!
Country [16]
0
0
Guatemala
Query!
State/province [16]
0
0
Guatemala City
Query!
Country [17]
0
0
Latvia
Query!
State/province [17]
0
0
Riga
Query!
Country [18]
0
0
Latvia
Query!
State/province [18]
0
0
Valmiera
Query!
Country [19]
0
0
Lithuania
Query!
State/province [19]
0
0
Kaunas
Query!
Country [20]
0
0
Lithuania
Query!
State/province [20]
0
0
Kedainiai
Query!
Country [21]
0
0
Lithuania
Query!
State/province [21]
0
0
Klaipeda
Query!
Country [22]
0
0
Lithuania
Query!
State/province [22]
0
0
Siauliai
Query!
Country [23]
0
0
Lithuania
Query!
State/province [23]
0
0
Vilnius
Query!
Country [24]
0
0
Mexico
Query!
State/province [24]
0
0
Culiacan
Query!
Country [25]
0
0
Mexico
Query!
State/province [25]
0
0
Guadalajara
Query!
Country [26]
0
0
Mexico
Query!
State/province [26]
0
0
Mexicali
Query!
Country [27]
0
0
Norway
Query!
State/province [27]
0
0
Oslo
Query!
Country [28]
0
0
Poland
Query!
State/province [28]
0
0
Katowice
Query!
Country [29]
0
0
Poland
Query!
State/province [29]
0
0
Kutno
Query!
Country [30]
0
0
Poland
Query!
State/province [30]
0
0
Lublin
Query!
Country [31]
0
0
Poland
Query!
State/province [31]
0
0
Wroclaw
Query!
Country [32]
0
0
Russian Federation
Query!
State/province [32]
0
0
Moscow
Query!
Country [33]
0
0
Russian Federation
Query!
State/province [33]
0
0
Yaroslavl
Query!
Country [34]
0
0
Russian Federation
Query!
State/province [34]
0
0
Yekaterinburg
Query!
Country [35]
0
0
Singapore
Query!
State/province [35]
0
0
Singapore
Query!
Country [36]
0
0
Sweden
Query!
State/province [36]
0
0
Goeteborg
Query!
Country [37]
0
0
Sweden
Query!
State/province [37]
0
0
Stockholm
Query!
Country [38]
0
0
Switzerland
Query!
State/province [38]
0
0
Lausanne
Query!
Country [39]
0
0
Ukraine
Query!
State/province [39]
0
0
Donetsk
Query!
Country [40]
0
0
Ukraine
Query!
State/province [40]
0
0
Kyiv
Query!
Country [41]
0
0
Ukraine
Query!
State/province [41]
0
0
Lviv
Query!
Country [42]
0
0
Ukraine
Query!
State/province [42]
0
0
Zaporizhzhya
Query!
Country [43]
0
0
United States of America
Query!
State/province [43]
0
0
Arizona
Query!
Country [44]
0
0
United States of America
Query!
State/province [44]
0
0
California
Query!
Country [45]
0
0
United States of America
Query!
State/province [45]
0
0
Colorado
Query!
Country [46]
0
0
United States of America
Query!
State/province [46]
0
0
Florida
Query!
Country [47]
0
0
United States of America
Query!
State/province [47]
0
0
Georgia
Query!
Country [48]
0
0
United States of America
Query!
State/province [48]
0
0
Illinois
Query!
Country [49]
0
0
United States of America
Query!
State/province [49]
0
0
Missouri
Query!
Country [50]
0
0
United States of America
Query!
State/province [50]
0
0
New York
Query!
Country [51]
0
0
United States of America
Query!
State/province [51]
0
0
Ohio
Query!
Country [52]
0
0
United States of America
Query!
State/province [52]
0
0
Oklahoma
Query!
Country [53]
0
0
United States of America
Query!
State/province [53]
0
0
Oregon
Query!
Country [54]
0
0
United States of America
Query!
State/province [54]
0
0
Pennsylvania
Query!
Country [55]
0
0
United States of America
Query!
State/province [55]
0
0
Tennessee
Query!
Country [56]
0
0
United States of America
Query!
State/province [56]
0
0
Vermont
Query!
Country [57]
0
0
United States of America
Query!
State/province [57]
0
0
Wisconsin
Query!
Country [58]
0
0
Argentina
Query!
State/province [58]
0
0
Buenos Aires
Query!
Country [59]
0
0
Argentina
Query!
State/province [59]
0
0
Ciudad de Buenos Aires
Query!
Country [60]
0
0
Chile
Query!
State/province [60]
0
0
Santiago
Query!
Country [61]
0
0
Chile
Query!
State/province [61]
0
0
Vina del Mar
Query!
Country [62]
0
0
Colombia
Query!
State/province [62]
0
0
Cundinamarca
Query!
Country [63]
0
0
Colombia
Query!
State/province [63]
0
0
Risaralda
Query!
Country [64]
0
0
Colombia
Query!
State/province [64]
0
0
Santander
Query!
Country [65]
0
0
Colombia
Query!
State/province [65]
0
0
Valle
Query!
Country [66]
0
0
Colombia
Query!
State/province [66]
0
0
Valle del Cauca
Query!
Country [67]
0
0
Hong Kong
Query!
State/province [67]
0
0
Hong Kong SAR, China
Query!
Country [68]
0
0
Hong Kong
Query!
State/province [68]
0
0
Hong Kong
Query!
Country [69]
0
0
Japan
Query!
State/province [69]
0
0
Tokyo
Query!
Country [70]
0
0
Japan
Query!
State/province [70]
0
0
Chiba
Query!
Country [71]
0
0
Japan
Query!
State/province [71]
0
0
Fukuoka
Query!
Country [72]
0
0
Japan
Query!
State/province [72]
0
0
Hiroshima
Query!
Country [73]
0
0
Japan
Query!
State/province [73]
0
0
Kanagawa
Query!
Country [74]
0
0
Japan
Query!
State/province [74]
0
0
Kumamoto
Query!
Country [75]
0
0
Japan
Query!
State/province [75]
0
0
Kyoto
Query!
Country [76]
0
0
Japan
Query!
State/province [76]
0
0
Nagano
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novartis Pharmaceuticals
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01071213
Query!
Trial related presentations / publications
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
Query!
Address
0
0
Novartis Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01071213
Download to PDF