β-RELIEVED-II: Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01080131
Collaborator
(none)
226
108
2
19
2.1
0.1
Study Details
Study Description
Brief Summary
The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide.
The purpose of the first 12 week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2357.
The purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
226 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective Including a 12 Weeks Extension Study and a 1 Year Open-label Extension Study
Study Start Date
:
Mar 1, 2010
Actual Primary Completion Date
:
Nov 1, 2010
Actual Study Completion Date
:
Oct 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Canakinumab 150 mg Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Participants completing the 12 week core study could continue to be treated in a 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months. |
Drug: Canakinumab 150 mg
Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).
Drug: Placebo to triamcinolone acetonide
Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.
|
| Active Comparator: Triamcinolone acetonide 40 mg Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Participants completing the 12 week core study could continue to be treated in a 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study. In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year. Triamcinolone acetonide was not to be administered in the second extension study. |
Drug: Triamcinolone acetonide 40 mg
Triamcinolone acetonide 40 mg was supplied as a suspension.
Drug: Placebo to canakinumab
Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.
|
Outcome Measures
Primary Outcome Measures
- Time to First New Flare: Survival Analysis During the 12 Weeks of Study [Baseline to 12 weeks]
Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely.
- Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose [72 hours post-dose (randomization)]
Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.
- Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks [During 24 weeks overall]
This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
- Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall) [72 weeks]
This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Secondary Outcome Measures
- Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) [Baseline to 7 days post-dose (randomization)]
Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose.
- Time to Complete Resolution of Pain; Survival Analysis [Baseline to 7 days post-dose (randomization)]
Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose.
- SF 36 Physical Function Score at Week 12 [Week 12]
SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates.
- Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study [Baseline to Week 12]
The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period.
- Pharmacokinetic Concentrations [12 weeks post-dose]
Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL.
- Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS) [6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization)]
Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates.
- Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS) [6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks).]
Patient's assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates.
- Time to the First New Gout Flare During 24 Weeks [From randomization to the end of the first extension period (24 weeks).]
Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had: Flare in joint, not a previously affected joint (at baseline or during study) Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.
- Mean Number of New Gout Flares Per Patient During 24 Weeks [24 weeks]
Patients met definition of new flare if they had: Flare in joint, not a previously affected joint(at baseline or during study) Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.
- Time to First Intake of Rescue Medication [For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).]
Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare. Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication. Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks).
- Percentage of Participants Who Took Rescue Medication [For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).]
Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare. Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication.
- Amount of Rescue Medication Taken [For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).]
Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare.
- Physician's Global Assessment of Response to Treatment [72 hours post-dose and 24-weeks post-dose.]
The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's own assessments (pain intensity and patient's global assessment of response to treatment).
- Patient's Global Assessment of Response to Treatment [72 hours post-dose and 24 weeks post-dose]
Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported.
- Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint [72 hours post-dose and 24 weeks post-dose]
The study physician assessed the most affected joint for: Tenderness on a 0-3 point scale: No pain, patient states that "there is pain", patient states "there is pain and winces", and patient states "there is pain, winces, and withdraws" on palpation or passive movement of the affected study joint; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported.
- Physician's Assessment of Range of Motion of the Most Affected Joint [72 hours post-dose and 24 weeks post-dose]
The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported.
- High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels [72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).]
High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates.
- Patient's Assessment of Gout Pain Intensity in the Most Affected Joint [72 hours post-dose and 24 weeks post-dose]
Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme).
- Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme [From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks).]
For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period.
- Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks [From randomization to the end of the second extension period (72 weeks).]
Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: Flare in joint, not a previously affected joint (at baseline or during study) Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely.
- Flare Rate Per Year [From randomization to the end of the second extension period (72 weeks).]
Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab. Participants met the definition of new flare if they had: Flare in joint, not a previously affected joint (at baseline or during study) Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Participants did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before the flare has resolved completely. Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate.
- Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab [72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.]
Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme). Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
- Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab [72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.]
Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
- Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab [72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.]
The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor. The physician completed the physician's global assessment of response to treatment without viewing any of the patient's assessments. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
- Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab [72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.]
The study physician assessed the most affected joint for tenderness on the following 4-point scale: no pain; participant states that "there is pain; participant states "there is pain and winces"; participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
- Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab [72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.]
The study physician assessed the most affected joint for swelling on the following 4-point scale: no swelling; palpable; visible; bulging beyond the joint margins. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
- Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab [72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.]
The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
- High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab [24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.]
High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
- Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab [24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.]
Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Core Study:
Inclusion criteria:
-
Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout
-
Onset of current acute gout flare within 5 days prior to study entry
-
Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
-
History of ≥ 3 gout flares within the 12 months prior to study entry
-
Contraindication, or intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAID) and/or colchicine
Exclusion criteria:
-
Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
-
Presence of severe renal function impairment
-
Use of specified pain relief medications or biologics (corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor within specified periods prior to study entry
-
Live vaccinations within 3 months prior to randomization
-
Requirement for administration of antibiotics against latent tuberculosis (TB)
-
Refractory heart failure (Stage D)
-
Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
-
Any active or recurrent bacterial, fungal, or viral infection
Extension Study 1:
Inclusion:
- Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7.
Exclusion:
- Continuation in this extension study was considered inappropriate by the treating physician.
Extension Study 2:
Inclusion Criteria:
- Completion of the first extension study CACZ885H2357E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).
Exclusion Criteria:
-Continuation in this second extension study was considered inappropriate by the treating physician.
Other protocol-defined inclusion-exclusion criteria applied to the core and extension studies.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pinnacle Research Group, LLC | Anniston | Alabama | United States | 36207 |
| 2 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
| 3 | Novartis Investigative site | Foley | Alabama | United States | 36535 |
| 4 | Horizon Research Group, Inc. | Mobile | Alabama | United States | 36608 |
| 5 | Sun Valley Arthritis Center, Ltd | Peoria | Arizona | United States | 85381 |
| 6 | Genova Clinical Research | Tucson | Arizona | United States | 85741 |
| 7 | Little Rock Diagnostic Clinic | Little Rock | Arkansas | United States | 72205 |
| 8 | Providence Research | Burbank | California | United States | 91505 |
| 9 | Diagnamics, Inc. | Carlsbad | California | United States | 92008 |
| 10 | Med Investigations | Fair Oaks | California | United States | 95628 |
| 11 | Valerius Medical Group and Research Center of Long Branch | Long Beach | California | United States | 90806 |
| 12 | Lucita M. Cruz, M.D., Inc. | Norwalk | California | United States | 90650 |
| 13 | Sierra Clinical Research | Orangevale | California | United States | 95662 |
| 14 | Chaparral Medical Grp, INC Clinical Research | Pomona | California | United States | 91767 |
| 15 | River City Clinical Research | Sacramento | California | United States | 95816 |
| 16 | Arthritis Associates | San Antonio | California | United States | 782209 |
| 17 | California Research Foundation | San Diego | California | United States | 92103 |
| 18 | Rochester clinical Research | San Diego | California | United States | 92108 |
| 19 | Ritchken and First MDs | San Diego | California | United States | 92117 |
| 20 | Huntington Medical Foundation | San Marino | California | United States | 91108 |
| 21 | Crest Clinical Trials | Santa Ana | California | United States | 92701 |
| 22 | Orange County Research Center | Tustin | California | United States | 92780 |
| 23 | Progressive Clinical Research | Vista | California | United States | 92803 |
| 24 | Center for Clinical Trials of San Gabriel | West Covina | California | United States | 91790 |
| 25 | Clinical Res Ct of CT - Arthritis Associates of CT/NY, LLC | Danbury | Connecticut | United States | 06810 |
| 26 | Innovative Research of West Florida | Clearwater | Florida | United States | 33756 |
| 27 | Health Awareness | Jupiter | Florida | United States | 33458 |
| 28 | Pines Research, LLC Pembroke Clinical Trials | Pembroke Pines | Florida | United States | 33028 |
| 29 | DMI Healthcare Group, Inc. | Pinellas Park | Florida | United States | 33782 |
| 30 | Tampa Medical Group, P.A. | Tampa | Florida | United States | 33614 |
| 31 | RST DAta Research | Conyers | Georgia | United States | 30012 |
| 32 | Q Clinical Research | Decatur | Georgia | United States | 30035 |
| 33 | Harbin Clinic | Rome | Georgia | United States | 30165 |
| 34 | Sonora Clinical Research, LLC | Boise | Idaho | United States | 83702 |
| 35 | Northwest Clinical Trials | Boise | Idaho | United States | 83704 |
| 36 | The Arthritis Center | Springfield | Illinois | United States | 62704 |
| 37 | Deaconess Clinic | Evansville | Indiana | United States | 47713 |
| 38 | Pinnacle Medical Research | Overland Park | Kansas | United States | 66215 |
| 39 | Wichita Clinic | Wichita | Kansas | United States | 67208 |
| 40 | Dolby Research, LLC | Baton Rouge | Louisiana | United States | 70809 |
| 41 | Gulf Coast Research, LLC | Lafayette | Louisiana | United States | 70508 |
| 42 | Clinical Trials Management | Metairie | Louisiana | United States | 70006 |
| 43 | Arthritis and Diabetes Clinic | Monroe | Louisiana | United States | 71203 |
| 44 | Regional Research Specialists | Shreveport | Louisiana | United States | 71106 |
| 45 | The Family Doctors | Shreveport | Louisiana | United States | 71115 |
| 46 | Center for Rheumatology & Bone Research | Wheaton | Maryland | United States | 20902 |
| 47 | MASS Research, LLC | Waltham | Massachusetts | United States | 02453 |
| 48 | Clarkston Medical Group | Clarkston | Michigan | United States | 48346 |
| 49 | L Kage Healthcare Services | Flint | Michigan | United States | 48532 |
| 50 | West Michigan Rheumatology | Grand Rapids | Michigan | United States | 49546 |
| 51 | *Private Practice* | Lansing | Michigan | United States | 48910 |
| 52 | Oakland Medical Research Center | Troy | Michigan | United States | 48085 |
| 53 | Arthritis Associates of Mississippi | Jackson | Mississippi | United States | 39202 |
| 54 | CRC of Jackson | Jackson | Mississippi | United States | 39202 |
| 55 | Phillips Medical Center | Jackson | Mississippi | United States | 39209 |
| 56 | Montana Medical Research | Missoula | Montana | United States | 59808 |
| 57 | Quality Clinical Research | Omaha | Nebraska | United States | 68114 |
| 58 | Heartland Clinical Research, Inc. | Omaha | Nebraska | United States | 68134 |
| 59 | Clinical Research Advantage, Inc | Henderson | Nevada | United States | 89014 |
| 60 | Arthritis and Osteoporosis Associates | Freehold | New Jersey | United States | 07728 |
| 61 | UMDNJ Robert Wood Johnson Medical School | New Brunswick | New Jersey | United States | 08903 |
| 62 | Arthritis and Osteoporosis Medical Association | Brooklyn | New York | United States | 11201 |
| 63 | Andrew J. Porges, MD, PC | Roslyn | New York | United States | 11576 |
| 64 | Metrolina Medical Research | Charlotte | North Carolina | United States | 28209 |
| 65 | The Center For Nutrition and Preventive Medicine | Charlotte | North Carolina | United States | 28277 |
| 66 | Unifour Medical Research Associates | Hickory | North Carolina | United States | 28601 |
| 67 | Jones Family Practice, PA | Shelby | North Carolina | United States | 28150 |
| 68 | Columbia Arthritis Center | Columbus | Ohio | United States | 43215 |
| 69 | STAT Research, Inc. | Dayton | Ohio | United States | 45417 |
| 70 | Ohio Clinical Research, LLC | Willoughby Hills | Ohio | United States | 44094 |
| 71 | Humility of Mary Health Partners DBA St. Elizabeth Health Ce | Youngstown | Ohio | United States | 44501 |
| 72 | Health Research of Oklahoma, PLLC | Oklahoma City | Oklahoma | United States | 73103 |
| 73 | Health Research Institute | Oklahoma City | Oklahoma | United States | 73109 |
| 74 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 75 | Philadelphia VA medical Center | Philadelphia | Pennsylvania | United States | 19104 |
| 76 | Partners in Clinical Research | Bumberland | Rhode Island | United States | 02864 |
| 77 | Medical Research South | Charleston | South Carolina | United States | 29407 |
| 78 | Pharmacorp Clinical Trials, INC | Charleston | South Carolina | United States | 29412 |
| 79 | Tlm Medical Services Llc | Columbia | South Carolina | United States | 29204 |
| 80 | Palmetto Clinical Trial Services, LLC | Greenville | South Carolina | United States | 29601 |
| 81 | Community Research Partners, Inc. | Varnville | South Carolina | United States | 29924 |
| 82 | Community Research Partners, Inc. | Varnville | South Carolina | United States | 29944 |
| 83 | Tri-Cities Medical Research | Bristol | Tennessee | United States | 37620 |
| 84 | Alpha Clinical Research | Clarksville | Tennessee | United States | 37403 |
| 85 | The Jackson Clinic | Jackson | Tennessee | United States | 38301 |
| 86 | The Arthritis Clinic | Jackson | Tennessee | United States | 38305 |
| 87 | MultiSpecialty Clinical Research | Johnson City | Tennessee | United States | 37601 |
| 88 | Lovelace Scientific Resource | Austin | Texas | United States | 78758 |
| 89 | Rheumatic Disease Clinical Research Center, Llc | Houston | Texas | United States | 77004 |
| 90 | R/D Clinical Research, Inc. | Lake Jackson | Texas | United States | 77566 |
| 91 | Leander Healthcare Center | Leander | Texas | United States | 78641 |
| 92 | Accurate Clinical Research | Nassau Bay | Texas | United States | 77058 |
| 93 | North Hills Family Practice | North Richard Hills | Texas | United States | 76180 |
| 94 | Arthritis Center South Texas | San Antonio | Texas | United States | 78232 |
| 95 | Novartis Investigative site | Danville | Virginia | United States | 24541 |
| 96 | Health Research of Hampton Roads | Newport News | Virginia | United States | 23606 |
| 97 | Novartis Investigative Site | Vancouver | British Columbia | Canada | |
| 98 | Novartis Investigative Site | St-John's | Newfoundland and Labrador | Canada | |
| 99 | Novartis Investigative site | Sainte Foy | Quebec | Canada | |
| 100 | Novartis Investigative Site | Kaohsiung Hsien | Taiwan | China | |
| 101 | Novartis Investigative Site | Kaohsiung | Taiwan | China | |
| 102 | Novartis Investigative Site | Taichung | Taiwan | China | |
| 103 | Novartis Investigative Site | Taipei | Taiwan | China | |
| 104 | Novartis Investigative Site | Enschede | Netherlands | ||
| 105 | Novartis Investigative site | Leeuwarden | Netherlands | ||
| 106 | Novartis Investigative Site | Moscow | Russian Federation | ||
| 107 | Novartis Investigative Site | Yaroslavl | Russian Federation | ||
| 108 | Novartis Investigative Site | Yekaterinburg | Russian Federation |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01080131
Other Study ID Numbers:
- CACZ885H2357
- 2010-018913-32
- CACZ885H2357E1
- NCT01137344
- NCT01194921
First Posted:
Mar 3, 2010
Last Update Posted:
Jan 30, 2014
Last Verified:
Apr 1, 2013
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study. |
| Period Title: Core Study (0- 12 Weeks) | ||
| STARTED | 112 | 114 |
| COMPLETED | 99 | 103 |
| NOT COMPLETED | 13 | 11 |
| Period Title: Core Study (0- 12 Weeks) | ||
| STARTED | 84 | 76 |
| COMPLETED | 78 | 72 |
| NOT COMPLETED | 6 | 4 |
| Period Title: Core Study (0- 12 Weeks) | ||
| STARTED | 72 | 65 |
| Re-treated With or Switch to Canakinumab | 62 | 41 |
| COMPLETED | 64 | 54 |
| NOT COMPLETED | 8 | 11 |
Baseline Characteristics
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg | Total |
|---|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study. | Total of all reporting groups |
| Overall Participants | 112 | 114 | 226 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
50.6
(12.10)
|
52.6
(12.28)
|
51.6
(12.21)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
12
10.7%
|
9
7.9%
|
21
9.3%
|
| Male |
100
89.3%
|
105
92.1%
|
205
90.7%
|
Outcome Measures
| Title | Time to First New Flare: Survival Analysis During the 12 Weeks of Study |
|---|---|
| Description | Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: •Flare in joint, not a previously affected joint (at baseline or during study) •Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely. |
| Time Frame | Baseline to 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. |
| Measure Participants | 112 | 114 |
| Median (95% Confidence Interval) [Days] |
NA
|
NA
|
| Title | Time to at Least a 50% Reduction in Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) |
|---|---|
| Description | Kaplan-Meier estimates of the time to at least a 50% reduction in self-assessed pain intensity in the joint most affected at Baseline and the confidence intervals were determined along with 95% confidence interval. Patients scored their pain intensity on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Pain was scored at Baseline; at 6 and 12 hours post-dose; and at 1, 2, 3, 4, 5, 6, and 7 days post-dose. |
| Time Frame | Baseline to 7 days post-dose (randomization) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. |
| Measure Participants | 111 | 109 |
| Median (95% Confidence Interval) [hours] |
25.0
|
48.0
|
| Title | Time to Complete Resolution of Pain; Survival Analysis |
|---|---|
| Description | Kaplan-Meier estimates of the time to complete resolution of self-assessed pain intensity in the joint most affected and the confidence interval was determined. Patients scored their pain intensity on a 5-point Likert scale (none, mild, moderate, severe, extreme). Pain was scored at Baseline; 6 and 12 hours; 1, 2, 3, 4, 5, 6, and 7 days post-dose. |
| Time Frame | Baseline to 7 days post-dose (randomization) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS): All patients that received study drug. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. |
| Measure Participants | 112 | 114 |
| Number (95% Confidence Interval) [hours] |
144.0
|
NA
|
| Title | SF 36 Physical Function Score at Week 12 |
|---|---|
| Description | SF-36 measures impact of disease on overall quality of life (QoL). 36-item survey has 8 subscales that can be aggregated into physical and mental component summary scores. Scores are standardized with the use of norm-based methods based on assessment of the general U.S. population free of chronic conditions. Scores range from 1-100 with a mean=50 and a standard deviation=10. A higher score indicates less impact on QoL. Analysis of covariance (ANCOVA) model was used with treatment group and baseline SF-36 physical function subscore as covariates. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Participants with observations at Week 12 were included in the analysis. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. |
| Measure Participants | 83 | 81 |
| Least Squares Mean (Standard Error) [Units on a scale] |
81.46
(2.786)
|
78.75
(2.820)
|
| Title | Percentage of Participants With at Least 1 New Gout Flare During the 12 Weeks of the Study |
|---|---|
| Description | The percentage of participants who experienced at least 1 new gout flare during the 12 week study treatment period. |
| Time Frame | Baseline to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. |
| Measure Participants | 112 | 114 |
| Number [percentage of participants] |
13.4
12%
|
36.8
32.3%
|
| Title | Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose |
|---|---|
| Description | Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), at 72 hours post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The analysis of covariance (ANCOVA) analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates. |
| Time Frame | 72 hours post-dose (randomization) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. Last Observation Carried Forward (LOCF) method was used to impute post dose measurement. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. |
| Measure Participants | 111 | 109 |
| Least Squares Mean (Standard Error) [mm] |
22.1
(2.33)
|
31.9
(2.35)
|
| Title | Pharmacokinetic Concentrations |
|---|---|
| Description | Canakinumab concentration was analyzed in serum by means of a competitive Enzyme-linked immunosorbent assay (ELISA) assay with a lower limit of quantification (LOQ) at 100 ng/mL. |
| Time Frame | 12 weeks post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. |
| Arm/Group Title | Canakinumab 150 mg |
|---|---|
| Arm/Group 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 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. |
| Measure Participants | 99 |
| Mean (Standard Deviation) [µg/mL] |
2.16
(2.375)
|
| Title | Self-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100 mm VAS) |
|---|---|
| Description | Patients scored their pain intensity in the joint most affected at Baseline on a 0-100 mm VAS, ranging from no pain (0) to unbearable pain (100), from 6 hours to 7 days post-dose. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The ANCOVA analysis included treatment group, Baseline VAS score, and body mass index (BMI) at Baseline as covariates. |
| Time Frame | 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose (randomization) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. |
| Measure Participants | 112 | 114 |
| 6 hours post-dose |
58.7
(1.94)
|
60.3
(1.96)
|
| 12 hours post-dose |
50.8
(2.16)
|
52.0
(2.18)
|
| 24 hours post-dose |
39.1
(2.39)
|
45.0
(2.41)
|
| 48 hours post-dose |
29.5
(2.45)
|
38.9
(2.48)
|
| 72 hours post-dose |
22.1
(2.33)
|
31.9
(2.35)
|
| 4 days post-dose |
19.2
(2.25)
|
27.7
(2.27)
|
| 5 days post-dose |
16.4
(2.23)
|
25.4
(2.25)
|
| 6 days post-dose |
14.3
(2.20)
|
22.3
(2.22)
|
| 7 days post-dose |
14.0
(2.18)
|
19.5
(2.20)
|
| Title | Self-assessed Pain Intensity in the Joint Most Affected at Last Post-Baseline Measured on a Visual Analog Scale (VAS) |
|---|---|
| Description | Patient's assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) for the last post-baseline flare, ranging from no pain (0) to unbearable pain (100), was summarized up to 7 days after receiving a re-dose of study drug by time point. Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. The covariance analysis included treatment group, Baseline VAS score at that flare, and body mass index (BMI) at Baseline as covariates. |
| Time Frame | 6, 12, 24, 48, and 72 hours; and 4, 5, 6, and 7 days post-dose for last post-baseline flare that occurred up until the end of the first extension study (24 weeks). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. For assessments made up to 7 days after re-dosing, pain values were imputed using the Last- Observation-Carried-Forward (LOCF) method. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 25 | 46 |
| 6 hours post-dose |
57.4
(3.07)
|
59.1
(2.26)
|
| 12 hours post-dose |
50.7
(4.24)
|
53.3
(3.12)
|
| 24 hours post-dose |
46.2
(4.74)
|
43.8
(3.49)
|
| 48 hours post-dose |
42.3
(4.96)
|
34.2
(3.65)
|
| 72 hours post-dose |
37.0
(5.12)
|
26.1
(3.77)
|
| 4 days post-dose |
31.3
(4.75)
|
23.4
(3.49)
|
| 5 days post-dose |
29.0
(5.11)
|
21.6
(3.76)
|
| 6 days post-dose |
28.1
(5.04)
|
20.5
(3.71)
|
| 7 days post-dose |
24.1
(5.03)
|
19.1
(3.70)
|
| Title | Time to the First New Gout Flare During 24 Weeks |
|---|---|
| Description | Kaplan-Meier (KM) estimates of the time to first new flare and confidence intervals were determined. Participants met the definition of a new flare if they had: Flare in joint, not a previously affected joint (at baseline or during study) Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. |
| Time Frame | From randomization to the end of the first extension period (24 weeks). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| Median (95% Confidence Interval) [days] |
NA
|
146
|
| Title | Mean Number of New Gout Flares Per Patient During 24 Weeks |
|---|---|
| Description | Patients met definition of new flare if they had: Flare in joint, not a previously affected joint(at baseline or during study) Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Participants did not meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. |
| Time Frame | 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| Mean (Standard Deviation) [new flares per patient] |
0.35
(0.694)
|
0.80
(1.115)
|
| Title | Time to First Intake of Rescue Medication |
|---|---|
| Description | Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare. Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication. Kaplan-Meier estimates of the time to first intake of rescue medication, in hours, and the confidence interval were determined for the flare experienced at study entry (Baseline flare) and the last new flare (last post-baseline flare) that occurred up until the end of the first extension period (24 weeks). |
| Time Frame | For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks). |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. Patients who did not take rescue medication had the time-to-first rescue medication intake censored at 7 days post dosing and re-dosing. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| Baseline flare [N= 112, 114] |
NA
|
37.5
|
| Last post-baseline flare [N=25, 46] |
32
|
NA
|
| Title | Percentage of Participants Who Took Rescue Medication |
|---|---|
| Description | Participants who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. If they had insufficient pain relief, participants were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare. Use of these treatments during the first 7 days of a gout flare was recorded as rescue medication. |
| Time Frame | For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks). |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| Baseline flare [N= 112, 114] |
43.8
39.1%
|
57.0
50%
|
| Last post-baseline flare [N=25, 46] |
56.0
50%
|
41.3
36.2%
|
| Title | Amount of Rescue Medication Taken |
|---|---|
| Description | Patients who had difficulty in tolerating their pain were allowed to take rescue medication after the 6-hour post-dose pain assessments as follows: Acetaminophen (paracetamol) 500 mg and/ or codeine 30 mg as required. A maximum of 1 g/dose or 3 g/day of acetaminophen and 30 mg/ dose or 180 mg/day of codeine was allowed. If they had insufficient pain relief, patients were allowed to take a maximum of 30 mg of oral prednisolone as required per day for 2 days followed by up to 20 mg of prednisolone as required subsequent days within 7 days of a gout flare. |
| Time Frame | For 7 days after the first dose for the baseline flare and 7 days post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks). |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| Baseline flare: Acetaminophen [N=112, 114] |
1375.0
(2726.63)
|
2526.5
(3925.13)
|
| Baseline flare: Codeine [N=112, 114] |
27.2
(100.40)
|
60.6
(144.38)
|
| Baseline flare: Prednisone/Predinisone [N=112,114] |
9.2
(35.32)
|
19.3
(44.88)
|
| Last flare: Acetaminophen [N=25, 46] |
2292.0
(3462.65)
|
1541.3
(3771.33)
|
| Last flare: Codeine [N= 25, 46] |
64.8
(224.11)
|
65.2
(178.70)
|
| Last flare: Prednisolone/Predinisone [N= 25, 46] |
5.6
(14.46)
|
18.3
(48.00)
|
| Title | Physician's Global Assessment of Response to Treatment |
|---|---|
| Description | The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: Very good, good, fair, poor, very poor. The percentage of patients in each category is reported. The physician completed the assessment without viewing any of the patient's own assessments (pain intensity and patient's global assessment of response to treatment). |
| Time Frame | 72 hours post-dose and 24-weeks post-dose. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available for this endpoint at the specified time point. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| 72 hours - Very good [N= 107, 109] |
43.0
38.4%
|
25.7
22.5%
|
| 72 hours - Good [N= 107, 109] |
43.0
38.4%
|
35.8
31.4%
|
| 72 hours - Fair [N= 107, 109] |
11.2
10%
|
26.6
23.3%
|
| 72 hours - Poor [N= 107, 109] |
2.8
2.5%
|
6.4
5.6%
|
| 72 hours - Very poor [N= 107, 109] |
0.0
0%
|
5.5
4.8%
|
| 24 weeks - Very good [N=79, 71] |
77.2
68.9%
|
66.2
58.1%
|
| 24 weeks - Good [N=79, 71] |
16.5
14.7%
|
29.6
26%
|
| 24 weeks - Fair [N=79, 71] |
5.1
4.6%
|
4.2
3.7%
|
| 24 weeks - Poor [N=79, 71] |
1.3
1.2%
|
0.0
0%
|
| 24 weeks - Very poor [N=79, 71] |
0.0
0%
|
0.0
0%
|
| Title | Number of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks |
|---|---|
| Description | This was primary endpoint of extension study 1. Adverse event is defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. A serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. |
| Time Frame | During 24 weeks overall |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| Adverse event |
78
69.6%
|
65
57%
|
| Death |
1
0.9%
|
0
0%
|
| Serious adverse event |
7
6.3%
|
2
1.8%
|
| Title | Patient's Global Assessment of Response to Treatment |
|---|---|
| Description | Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight, poor. The percentage of participants in each category is reported. |
| Time Frame | 72 hours post-dose and 24 weeks post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| 72 hours - Excellent [N=108, 108] |
36.1
32.2%
|
19.4
17%
|
| 72 hours - Good [N=108, 108] |
37.0
33%
|
32.4
28.4%
|
| 72 hours - Acceptable [N=108, 108] |
18.5
16.5%
|
13.9
12.2%
|
| 72 hours - Slight [N=108, 108] |
4.6
4.1%
|
25.0
21.9%
|
| 72 hours - Poor [N=108, 108] |
3.7
3.3%
|
9.3
8.2%
|
| 24 weeks - Excellent [N=79, 72] |
59.5
53.1%
|
40.3
35.4%
|
| 24 weeks - Good [N=79, 72] |
26.6
23.8%
|
44.4
38.9%
|
| 24 weeks - Acceptable [N=79, 72] |
6.3
5.6%
|
13.9
12.2%
|
| 24 weeks - Slight [N=79, 72] |
6.3
5.6%
|
1.4
1.2%
|
| 24 weeks - Poor [N=79, 72] |
1.3
1.2%
|
0.0
0%
|
| Title | Physician's Assessment of Tenderness, Swelling, and Erythema of the Most Affected Joint |
|---|---|
| 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; Swelling on a 0-3 point scale: No swelling, palpable, visible, and bulging beyond the joint margins; and Erythema: Present or absent. The percentage of participants in each category is reported. |
| Time Frame | 72 hours post-dose and 24 weeks post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| 72 hours - Tenderness: No pain [N=107, 109] |
47.7
42.6%
|
30.3
26.6%
|
| 72 hours - Tenderness: Pain [N=107, 109] |
43.9
39.2%
|
46.8
41.1%
|
| 72 hours - Tenderness: Pain & winces [N=107, 109] |
4.7
4.2%
|
14.7
12.9%
|
| 72 hours - Tenderness:Winces/withdraws [N=107,109] |
3.7
3.3%
|
8.3
7.3%
|
| 24 weeks - Tenderness: No pain [N=79, 71] |
88.6
79.1%
|
91.5
80.3%
|
| 24 weeks - Tenderness: Pain [N=79, 71] |
8.9
7.9%
|
5.6
4.9%
|
| 24 weeks - Tenderness: Pain and winces [N=79, 71] |
1.3
1.2%
|
1.4
1.2%
|
| 24 weeks - Tenderness: Winces/withdraws [N=79, 71] |
1.3
1.2%
|
1.4
1.2%
|
| 72 hours - Swelling: No swelling [N=107,109] |
47.7
42.6%
|
35.8
31.4%
|
| 72 hours - Swelling: Palpable [N=107,109] |
28.0
25%
|
29.4
25.8%
|
| 72 hours - Swelling: Visible [N=107,109] |
22.4
20%
|
28.4
24.9%
|
| 72 hours - Swelling: Bulging [N=107,109] |
1.9
1.7%
|
6.4
5.6%
|
| 24 weeks - Swelling: No swelling [N=79, 71] |
93.7
83.7%
|
94.4
82.8%
|
| 24 weeks - Swelling: Palpable [N=79, 71] |
5.1
4.6%
|
4.2
3.7%
|
| 24 weeks - Swelling: Visible [N=79, 71] |
1.3
1.2%
|
1.4
1.2%
|
| 24 weeks - Swelling: Bulging [N=79, 71] |
0.0
0%
|
0.0
0%
|
| 72 hours - Erythema: Absent [N=107, 108] |
74.8
66.8%
|
66.7
58.5%
|
| 72 hours - Erythema: Present [N=107, 108] |
25.2
22.5%
|
33.3
29.2%
|
| 24 weeks - Erythema: Absent [N=79, 71] |
97.5
87.1%
|
97.2
85.3%
|
| 24 weeks - Erythema: Present [N=79, 71] |
2.5
2.2%
|
2.8
2.5%
|
| Title | Physician's Assessment of Range of Motion of the Most Affected Joint |
|---|---|
| Description | The study physician assessed the range of motion of the most affected joint for range of motion on a 5-point Likert scale: Normal, mildly restricted, moderately restricted, severely restricted, immobilized. The percentage of participants in each category is reported. |
| Time Frame | 72 hours post-dose and 24 weeks post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| 72 hours - Normal [N=107,109] |
47.7
42.6%
|
28.4
24.9%
|
| 72 hours - Mildly restricted [N=107,109] |
37.4
33.4%
|
45.9
40.3%
|
| 72 hours - Moderately restricted [N=107,109] |
13.1
11.7%
|
20.2
17.7%
|
| 72 hours - Severely restricted [N=107,109] |
1.9
1.7%
|
5.5
4.8%
|
| 72 hours - Immobilized [N=107,109] |
0.0
0%
|
0.0
0%
|
| 24 weeks - Normal [N=79, 71] |
86.1
76.9%
|
97.2
85.3%
|
| 24 weeks - Mildly restricted [N=79, 71] |
10.1
9%
|
2.8
2.5%
|
| 24 weeks - Moderately restricted [N=79, 71] |
2.5
2.2%
|
0.0
0%
|
| 24 weeks - Severely restricted [N=79, 71] |
1.3
1.2%
|
0.0
0%
|
| 24 weeks - Immobilized [N=79, 71] |
0.0
0%
|
0.0
0%
|
| Title | Number of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall) |
|---|---|
| Description | This was the primary endpoint of extension study 2. An adverse event was defined as any unfavorable and unintended diagnosis, symptom sign including an abnormal laboratory finding, syndrome or disease which either occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse event is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. |
| Time Frame | 72 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population consisted of all patients who received study drug in the core study and had at least one post-baseline safety assessment. |
| Arm/Group Title | All Canakinumab | Canakinumab: Before Retreatment | Canakinumab: After Retreatment | All Triamcinolone Acetonide | Triam: Before Switch to Canakinumab | Triam: After Switch to Canakinumab |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months. | Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab. | Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab. | Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare. Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab. | Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab. | Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab. |
| Measure Participants | 112 | 62 | 62 | 114 | 41 | 41 |
| Any adverse event |
85
75.9%
|
44
38.6%
|
39
17.3%
|
70
NaN
|
29
NaN
|
27
NaN
|
| Death |
1
0.9%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Serious adverse event |
12
10.7%
|
1
0.9%
|
5
2.2%
|
4
NaN
|
0
NaN
|
3
NaN
|
| Title | High-sensitivity C-reactive Protein (hsCRP) and Serum Amyloid A Protein (SAA) Levels |
|---|---|
| Description | High sensitivity C-reactive protein (hsCRP) and serum amyloid A (SAA) were determined in blood serum in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Analyses were measured by a central laboratory. The analysis included treatment group, log-transformed protein level at baseline, and body mass index (BMI) at baseline as covariates. |
| Time Frame | 72 hours after the first dose for the baseline flare and 72 hours post-dose for the last post-baseline flare that occurred up until the end of the first extension study (24 weeks). |
Outcome Measure Data
| Analysis Population Description |
|---|
| For the Baseline flare the population analyzed consisted of the Full Analysis Set (FAS). For the last post-baseline flare the population analyzed consisted of patients re-treated for at least one new flare. "N" indicates the number of participants with available data in each analysis. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| Baseline flare: hsCRP [N=107, 110] |
3.84
|
6.38
|
| Baseline flare: SAA [N=95, 104] |
6.31
|
15.85
|
| Last post-baseline flare: hsCRP [N= 22, 42] |
3.69
|
4.32
|
| Last post-baseline flare: SAA, [N= 19, 39] |
6.74
|
11.04
|
| Title | Patient's Assessment of Gout Pain Intensity in the Most Affected Joint |
|---|---|
| Description | Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe, extreme). |
| Time Frame | 72 hours post-dose and 24 weeks post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. 'N' in each category indicates participants with observations available at the specified time point. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 112 | 114 |
| 72 hours - None [N=108, 111] |
30.6
27.3%
|
18.0
15.8%
|
| 72 hours - Mild [N=108, 111] |
48.1
42.9%
|
45.0
39.5%
|
| 72 hours - Moderate [N=108, 111] |
20.4
18.2%
|
27.0
23.7%
|
| 72 hours - Severe [N=108, 111] |
0.9
0.8%
|
8.1
7.1%
|
| 72 hours - Extreme [N=108, 111] |
0.0
0%
|
1.8
1.6%
|
| 24 weeks - None [N=79, 70] |
72.2
64.5%
|
67.1
58.9%
|
| 24 weeks - Mild [N=79, 70] |
19.0
17%
|
25.7
22.5%
|
| 24 weeks - Moderate [N=79, 70] |
6.3
5.6%
|
7.1
6.2%
|
| 24 weeks - Severe [N=79, 70] |
2.5
2.2%
|
0.0
0%
|
| 24 weeks - Extreme [N=79, 70] |
0.0
0%
|
0.0
0%
|
| Title | Percentage of Patients With Maximum Severity of New Gout Flares as Severe or Extreme |
|---|---|
| Description | For each new flare, participants scored the maximum amount of acute gout pain in the most affected joint since the onset of the new flare and the time they were re-dosed on a 5 point Likert scale as None, Mild, Moderate, Severe or Extreme. The percentage of participants with a maximum new flare severity of severe or extreme is reported for the first post-baseline flare that occurred during the 12-week core study and for the last post-baseline flare that occurred up until the end of the first extension period. |
| Time Frame | From the onset of a new flare until re-dosing. First post-baseline new flare during 12 week core study and the last post-baseline flare that occurred up until the end of the first extension study (24 weeks). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants analyzed (indicated by 'N') for the first new post-baseline flare includes patients who were re-treated for a new flare during the 12-week core study. For the last post-baseline flare the population analyzed includes patients re-treated for at least one new flare during the first 24 weeks. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. |
| Measure Participants | 25 | 46 |
| First post-baseline flare [N= 12, 37] |
66.7
59.6%
|
78.4
68.8%
|
| Last post-baseline flare [N= 25, 46] |
64.0
57.1%
|
78.3
68.7%
|
| Title | Time to First New Flare: Survival Analysis by Treatment Over 72 Weeks |
|---|---|
| Description | Kaplan-Meier estimates of time to first new flare and confidence intervals were determined. For patients with event, time to event = (date of event - date of first dose of study drug + 1). Patients met definition of new flare if they had: Flare in joint, not a previously affected joint (at baseline or during study) Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Patients did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before flare has resolved completely. |
| Time Frame | From randomization to the end of the second extension period (72 weeks). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study. |
| Measure Participants | 112 | 114 |
| Median (95% Confidence Interval) [days] |
254.0
|
146.0
|
| Title | Flare Rate Per Year |
|---|---|
| Description | Flare rate was calculated as the number of new flares over the period of observation in years. Flare rate was calculated using only those new flares before switching to canakinumab. Participants met the definition of new flare if they had: Flare in joint, not a previously affected joint (at baseline or during study) Flare in joint previously affected (at baseline or during study) after previous flare in joint has resolved completely. Participants did not meet criterion of having new gout flare if: • Increasing/renewed gout pain in an affected joint before the flare has resolved completely. Flare rates were estimated from a negative binomial model with body mass index at baseline as a covariate. |
| Time Frame | From randomization to the end of the second extension period (72 weeks). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (FAS) consisted of all patients as randomized in the core study who had taken at least one dose of study drug. |
| Arm/Group Title | Canakinumab 150 mg | Triamcinolone Acetonide 40 mg |
|---|---|---|
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months. | Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare. In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study. |
| Measure Participants | 112 | 114 |
| Mean (95% Confidence Interval) [flares per patient per year] |
1.18
|
2.02
|
| Title | Patient's Assessment of Gout Pain Intensity for Participants Re-treated or Switched to Canakinumab |
|---|---|
| Description | Participants scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none, mild, moderate, severe or extreme). Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2. |
| Time Frame | 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included. |
| Arm/Group Title | Re-treated With Canakinumab 150 mg | Triam Switched to Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm. | Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab. |
| Measure Participants | 62 | 41 |
| 72 hours - None [N=59, 40] |
30.5
27.2%
|
25.0
21.9%
|
| 72 hours - Mild [N=59, 40] |
44.1
39.4%
|
62.5
54.8%
|
| 72 hours - Moderate [N=59, 40] |
22.0
19.6%
|
12.5
11%
|
| 72 hours - Severe [N=59, 40] |
3.4
3%
|
0.0
0%
|
| 72 hours - Extreme [N=59, 40] |
0.0
0%
|
0.0
0%
|
| 7 days - None [N=57, 37] |
64.9
57.9%
|
59.5
52.2%
|
| 7 days - Mild [N=57, 37] |
21.1
18.8%
|
35.1
30.8%
|
| 7 days - Moderate [N=57, 37] |
10.5
9.4%
|
5.4
4.7%
|
| 7 days - Severe [N=57, 37] |
3.5
3.1%
|
0.0
0%
|
| 7 days - Extreme [N=57, 37] |
0.0
0%
|
0.0
0%
|
| Title | Patient's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab |
|---|---|
| Description | Participants made a global assessment of response to treatment using a 5-point Likert scale: Excellent, good, acceptable, slight or poor. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2. |
| Time Frame | 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included. |
| Arm/Group Title | Re-treated With Canakinumab 150 mg | Triam Switched to Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm. | Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab. |
| Measure Participants | 62 | 41 |
| 72 hours - Excellent [N=58, 38] |
41.4
37%
|
36.8
32.3%
|
| 72 hours - Good [N=58, 38] |
32.8
29.3%
|
39.5
34.6%
|
| 72 hours - Acceptable [N=58, 38] |
12.1
10.8%
|
21.1
18.5%
|
| 72 hours - Slight [N=58, 38] |
13.8
12.3%
|
2.6
2.3%
|
| 72 hours - Poor [N=58, 38] |
0.0
0%
|
0.0
0%
|
| 7 days - Excellent [N=56, 39] |
51.8
46.3%
|
51.3
45%
|
| 7 days - Good [N=56, 39] |
26.8
23.9%
|
33.3
29.2%
|
| 7 days - Acceptable [N=56, 39] |
10.7
9.6%
|
7.7
6.8%
|
| 7 days - Slight [N=56, 39] |
7.1
6.3%
|
7.7
6.8%
|
| 7 days - Poor [N=56, 39] |
3.6
3.2%
|
0.0
0%
|
| Title | Physician's Global Assessment of Response to Treatment for Participants Re-treated or Switched to Canakinumab |
|---|---|
| Description | The study physician made a global assessment of the patient's response to treatment using a 5-point Likert scale: very good, good, fair, poor or very poor. The physician completed the physician's global assessment of response to treatment without viewing any of the patient's assessments. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2. |
| Time Frame | 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included. |
| Arm/Group Title | Re-treated With Canakinumab 150 mg | Triam Switched to Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm. | Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab. |
| Measure Participants | 62 | 41 |
| 72 hours - Very good [N=56, 38] |
39.3
35.1%
|
42.1
36.9%
|
| 72 hours - Good [N=56, 38] |
39.3
35.1%
|
39.5
34.6%
|
| 72 hours - Fair [N=56, 38] |
16.1
14.4%
|
18.4
16.1%
|
| 72 hours - Poor [N=56, 38] |
5.4
4.8%
|
0.0
0%
|
| 72 hours - Very poor [N=56, 38] |
0.0
0%
|
0.0
0%
|
| 7 days - Very good [N=58, 39] |
56.9
50.8%
|
59.0
51.8%
|
| 7 days - Good [N=58, 39] |
25.9
23.1%
|
38.5
33.8%
|
| 7 days - Fair [N=58, 39] |
15.5
13.8%
|
2.6
2.3%
|
| 7 days - Poor [N=58, 39] |
1.7
1.5%
|
0.0
0%
|
| 7 days - Very poor [N=58, 39] |
0.0
0%
|
0.0
0%
|
| Title | Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab |
|---|---|
| Description | The study physician assessed the most affected joint for tenderness on the following 4-point scale: no pain; participant states that "there is pain; participant states "there is pain and winces"; participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2. |
| Time Frame | 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included. |
| Arm/Group Title | Re-treated With Canakinumab 150 mg | Triam Switched to Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm. | Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab. |
| Measure Participants | 62 | 41 |
| 72 hours - No pain [N=56, 38] |
51.8
46.3%
|
42.1
36.9%
|
| 72 hours - Pain [N=56, 38] |
37.5
33.5%
|
50.0
43.9%
|
| 72 hours - Pain and winces [N=56, 38] |
5.4
4.8%
|
5.3
4.6%
|
| 72 hours - Pain, winces and withdraws [N=56, 38] |
5.4
4.8%
|
2.6
2.3%
|
| 7 days - No pain [N=58, 39] |
74.1
66.2%
|
79.5
69.7%
|
| 7 days - Pain [N=58, 39] |
22.4
20%
|
20.5
18%
|
| 7 days - Pain and winces [N=58, 39] |
3.4
3%
|
0.0
0%
|
| 7 days - Pain, winces and withdraws [N=58, 39] |
0.0
0%
|
0.0
0%
|
| Title | Physician's Assessment of Joint Swelling for Participants Re-treated or Switched to Canakinumab |
|---|---|
| Description | The study physician assessed the most affected joint for swelling on the following 4-point scale: no swelling; palpable; visible; bulging beyond the joint margins. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2. |
| Time Frame | 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included. |
| Arm/Group Title | Re-treated With Canakinumab 150 mg | Triam Switched to Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm. | Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab. |
| Measure Participants | 62 | 41 |
| 72 hours - No swelling [N=56, 38] |
55.4
49.5%
|
47.4
41.6%
|
| 72 hours - Palpable [N=56, 38] |
26.8
23.9%
|
34.2
30%
|
| 72 hours - Visible [N=56, 38] |
12.5
11.2%
|
15.8
13.9%
|
| 72 hours - Bulging beyond joint margins [N=56, 38] |
5.4
4.8%
|
2.6
2.3%
|
| 7 days - No swelling [N=58, 39] |
70.7
63.1%
|
79.5
69.7%
|
| 7 days - Palpable [N=58, 39] |
17.2
15.4%
|
17.9
15.7%
|
| 7 days - Visible [N=58, 39] |
10.3
9.2%
|
2.6
2.3%
|
| 7 days - Bulging beyond joint margins [N=58, 39] |
1.7
1.5%
|
0.0
0%
|
| Title | Physician's Assessment of Erythema for Participants Re-treated or Switched to Canakinumab |
|---|---|
| Description | The study physician assessed the most affected joint for erythema (redness of the skin) as either present, absent or not assessable. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2. |
| Time Frame | 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included. |
| Arm/Group Title | Re-treated With Canakinumab 150 mg | Triam Switched to Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm. | Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab. |
| Measure Participants | 62 | 41 |
| 72 hours - Absent [N=56, 38] |
73.2
65.4%
|
92.1
80.8%
|
| 72 hours - Present [N=56, 38] |
26.8
23.9%
|
7.9
6.9%
|
| 7 days - Absent [N=58, 39] |
84.5
75.4%
|
94.9
83.2%
|
| 7 days - Present [N=58, 39] |
15.5
13.8%
|
5.1
4.5%
|
| Title | High-sensitivity C-reactive Protein (hsCRP) Levels for Participants Re-treated With or Switched to Canakinumab |
|---|---|
| Description | High sensitivity C-reactive protein (hsCRP) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2. |
| Time Frame | 24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included. |
| Arm/Group Title | Re-treated With Canakinumab 150 mg | Triam Switched to Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who received canakinumab 150 mg in the Ccre study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm. | Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab. |
| Measure Participants | 62 | 41 |
| 24-hours post-dose [N=48, 36] |
30.1
(64.11)
|
39.4
(41.10)
|
| 72-hours post-dose [N=56, 38] |
10.4
(31.11)
|
12.6
(15.80)
|
| 7 days post-dose [N=55, 40] |
2.8
(4.97)
|
3.5
(5.00)
|
| 4 weeks post-dose [N=46, 37] |
1.6
(2.30)
|
2.2
(3.54)
|
| 8 weeks post-dose [N=37, 35] |
2.1
(4.41)
|
2.4
(4.62)
|
| 12 weeks post-dose [N=38, 31] |
1.3
(0.79)
|
2.9
(4.90)
|
| Title | Serum Amyloid A Protein (SAA) Levels for Participants Re-treated With or Switched to Canakinumab |
|---|---|
| Description | Serum Amyloid A Protein (SAA) levels in blood serum were measured by a central laboratory in order to identify the presence of inflammation, to determine its severity, and to monitor the response to treatment. Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2. |
| Time Frame | 24 hours, 72 hours, 7 days, 4, 8 and 12 weeks post-dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included. |
| Arm/Group Title | Re-treated With Canakinumab 150 mg | Triam Switched to Canakinumab |
|---|---|---|
| Arm/Group Description | Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm. | Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab. |
| Measure Participants | 62 | 41 |
| 24-hours post-dose [N=47, 36] |
129.0
(324.45)
|
145.9
(257.44)
|
| 72-hours post-dose [N=54, 37] |
45.6
(163.45)
|
45.4
(97.00)
|
| 7 days post-dose [N=56, 39] |
5.7
(8.90)
|
5.9
(8.34)
|
| 4 weeks post-dose [N=47, 37] |
3.4
(3.67)
|
5.0
(7.02)
|
| 8 weeks post-dose [N=38, 35] |
3.5
(4.24)
|
5.3
(13.41)
|
| 12 weeks post-dose [N=38, 29] |
3.4
(2.37)
|
4.8
(5.94)
|
Adverse Events
| Time Frame | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | All Canakinumab | Canakinumab: Before Retreatment | Canakinumab: After Retreatment | All Triamcinolone Acetonide | Triam: Before Switch to Canakinumab | Triam: After Switch to Canakinumab | ||||||
| Arm/Group Description | Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare. In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months. | Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab. | Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab. | Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare. Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab. | Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab. | Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab. | ||||||
All Cause Mortality |
||||||||||||
| All Canakinumab | Canakinumab: Before Retreatment | Canakinumab: After Retreatment | All Triamcinolone Acetonide | Triam: Before Switch to Canakinumab | Triam: After Switch to Canakinumab | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| All Canakinumab | Canakinumab: Before Retreatment | Canakinumab: After Retreatment | All Triamcinolone Acetonide | Triam: Before Switch to Canakinumab | Triam: After Switch to Canakinumab | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/112 (10.7%) | 1/62 (1.6%) | 5/62 (8.1%) | 4/114 (3.5%) | 0/41 (0%) | 3/41 (7.3%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 1/41 (2.4%) | ||||||
| Haemorrhagic anaemia | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 1/41 (2.4%) | ||||||
| Cardiac disorders | ||||||||||||
| Angina pectoris | 1/112 (0.9%) | 0/62 (0%) | 1/62 (1.6%) | 0/114 (0%) | 0/41 (0%) | 1/41 (2.4%) | ||||||
| Aortic valve incompetence | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 1/114 (0.9%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Atrial fibrillation | 1/112 (0.9%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Cardiomyopathy | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 1/114 (0.9%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Congenital, familial and genetic disorders | ||||||||||||
| Bicuspid aortic valve | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 1/114 (0.9%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Diarrhoea | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 1/114 (0.9%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Lower gastrointestinal haemorrhage | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 1/41 (2.4%) | ||||||
| Nausea | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 1/114 (0.9%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Pancreatitis | 1/112 (0.9%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Vomiting | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 1/114 (0.9%) | 0/41 (0%) | 0/41 (0%) | ||||||
| General disorders | ||||||||||||
| Cyst | 1/112 (0.9%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Abscess limb | 2/112 (1.8%) | 1/62 (1.6%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Gastroenteritis | 1/112 (0.9%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Diabetes mellitus | 1/112 (0.9%) | 0/62 (0%) | 1/62 (1.6%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Back pain | 1/112 (0.9%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Intervertebral disc protrusion | 1/112 (0.9%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Prostate cancer | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 1/114 (0.9%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Squamous cell carcinoma | 1/112 (0.9%) | 0/62 (0%) | 1/62 (1.6%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Cerebrovascular accident | 1/112 (0.9%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Convulsion | 1/112 (0.9%) | 0/62 (0%) | 1/62 (1.6%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Haemorrhage intracranial | 1/112 (0.9%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Trigeminal neuralgia | 1/112 (0.9%) | 0/62 (0%) | 1/62 (1.6%) | 0/114 (0%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Psychiatric disorders | ||||||||||||
| Alcohol withdrawal syndrome | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 1/114 (0.9%) | 0/41 (0%) | 0/41 (0%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Acute prerenal failure | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 0/114 (0%) | 0/41 (0%) | 1/41 (2.4%) | ||||||
| Vascular disorders | ||||||||||||
| Aortic stenosis | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 1/114 (0.9%) | 0/41 (0%) | 0/41 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| All Canakinumab | Canakinumab: Before Retreatment | Canakinumab: After Retreatment | All Triamcinolone Acetonide | Triam: Before Switch to Canakinumab | Triam: After Switch to Canakinumab | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 42/112 (37.5%) | 15/62 (24.2%) | 19/62 (30.6%) | 36/114 (31.6%) | 15/41 (36.6%) | 8/41 (19.5%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Nausea | 3/112 (2.7%) | 2/62 (3.2%) | 1/62 (1.6%) | 3/114 (2.6%) | 1/41 (2.4%) | 3/41 (7.3%) | ||||||
| Infections and infestations | ||||||||||||
| Nasopharyngitis | 0/112 (0%) | 0/62 (0%) | 0/62 (0%) | 5/114 (4.4%) | 4/41 (9.8%) | 2/41 (4.9%) | ||||||
| Upper respiratory tract infection | 9/112 (8%) | 4/62 (6.5%) | 7/62 (11.3%) | 3/114 (2.6%) | 1/41 (2.4%) | 1/41 (2.4%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Muscle strain | 1/112 (0.9%) | 0/62 (0%) | 0/62 (0%) | 3/114 (2.6%) | 3/41 (7.3%) | 3/41 (7.3%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 8/112 (7.1%) | 1/62 (1.6%) | 5/62 (8.1%) | 10/114 (8.8%) | 3/41 (7.3%) | 2/41 (4.9%) | ||||||
| Back pain | 12/112 (10.7%) | 2/62 (3.2%) | 6/62 (9.7%) | 2/114 (1.8%) | 1/41 (2.4%) | 0/41 (0%) | ||||||
| Muscle spasms | 4/112 (3.6%) | 2/62 (3.2%) | 1/62 (1.6%) | 7/114 (6.1%) | 4/41 (9.8%) | 0/41 (0%) | ||||||
| Pain in extremity | 2/112 (1.8%) | 1/62 (1.6%) | 0/62 (0%) | 6/114 (5.3%) | 4/41 (9.8%) | 1/41 (2.4%) | ||||||
| Nervous system disorders | ||||||||||||
| Headache | 5/112 (4.5%) | 3/62 (4.8%) | 2/62 (3.2%) | 6/114 (5.3%) | 2/41 (4.9%) | 1/41 (2.4%) | ||||||
| Vascular disorders | ||||||||||||
| Hypertension | 14/112 (12.5%) | 3/62 (4.8%) | 7/62 (11.3%) | 7/114 (6.1%) | 2/41 (4.9%) | 1/41 (2.4%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862 778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01080131
Other Study ID Numbers:
- CACZ885H2357
- 2010-018913-32
- CACZ885H2357E1
- NCT01137344
- NCT01194921
First Posted:
Mar 3, 2010
Last Update Posted:
Jan 30, 2014
Last Verified:
Apr 1, 2013