A Study of the Efficacy of Canakinumab in Prevention of A... | NCT00819585 | Trialant
NCT00819585
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jul 17, 2018Actual
Enrollment
432Actual
Phase
Phase 2
Conditions
Gout
Interventions
Canakinumab
Colchicine
Allopurinol
Placebo Matching Canakinumab
Placebo Matching Colchicine
Countries
United States
Argentina
Belgium
Colombia
Czechia
Germany
Guatemala
Hungary
Poland
Portugal
Russia
Singapore
Slovakia
South Africa
Spain
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00819585
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CACZ885H2251
Secondary IDs
ID
Type
Description
Link
EudraCT : 2008-005876-28
Brief Title
A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
Official Title
A 24-week, Dose-ranging, Multicenter, Double-blind, Double-dummy, Active-controlled Core Study to Evaluate Canakinumab for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy and a 24-week Open-label, Multicenter Extension Study to Assess Safety, Tolerability and Efficacy of Canakinumab in Patients With Gout Who Are Given Canakinumab at the Time of Gout Flare
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2008
Primary Completion Date
Aug 2010Actual
Completion Date
Aug 2010Actual
First Submitted Date
Jan 8, 2009
First Submission Date that Met QC Criteria
Jan 8, 2009
First Posted Date
Jan 9, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 28, 2011
Results First Submitted that Met QC Criteria
Apr 12, 2011
Results First Posted Date
May 6, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 19, 2018
Last Update Posted Date
Jul 17, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.
Detailed Description
Not provided
Conditions Module
Conditions
Gout
Keywords
Gout
Chronic gout
Gouty arthritis
Gout flares
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
432Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Core study: Canakinumab 25 mg
Experimental
Canakinumab 25 mg subcutaneously (sc) once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
Drug: Canakinumab
Drug: Allopurinol
Drug: Placebo Matching Canakinumab
Drug: Placebo Matching Colchicine
Core study: Canakinumab 50 mg
Experimental
Canakinumab 50 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
Drug: Canakinumab
Drug: Allopurinol
Drug: Placebo Matching Canakinumab
Drug: Placebo Matching Colchicine
Core study: Canakinumab 100 mg
Experimental
Canakinumab 100 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
Drug: Canakinumab
Drug: Allopurinol
Drug: Placebo Matching Canakinumab
Drug: Placebo Matching Colchicine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Canakinumab
Drug
Canakinumab was supplied in glass vials as a lyophilized powder.
Core study: Canakinumab 100 mg
Core study: Canakinumab 200 mg
Core study: Canakinumab 25 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Core Study: Mean Number of Gout Flares Per Participant
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Baseline of the core study to Week 16
Secondary Outcomes
Measure
Description
Time Frame
Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab
up to 16 weeks after randomization
Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Core study
Inclusion Criteria:
Signed written informed consent before any study procedure is performed.
History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
Body Mass Index (BMI) ≤ 40 kg/m^2.
Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.
Exclusion Criteria:
Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
History of allergy or contraindication to colchicine or allopurinol.
History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
History of bone marrow suppression.
Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.
Extension study
Inclusion criteria:
Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
Patients who have signed a written informed consent before any trial procedure is performed.
Exclusion Criteria:
Patients for whom continuation in the extension study is not considered appropriate by the treating physician.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
Other protocol-defined inclusion/exclusion criteria applied to the study.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Talbert Medical Group
Huntington Beach
California
92646
United States
San Diego Arthritis & Osteoporosis Medical clinic
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 432 participants were enrolled in the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Core Study: Canakinumab 25 mg
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
FG001
Core Study: Canakinumab 50 mg
Periods
Title
Milestones
Reasons Not Completed
Core Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Core study: Canakinumab 200 mg
Experimental
Canakinumab 100 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
Drug: Canakinumab
Drug: Allopurinol
Drug: Placebo Matching Canakinumab
Drug: Placebo Matching Colchicine
Core study: Canakinumab 300 mg
Experimental
Canakinumab 300 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
Drug: Canakinumab
Drug: Allopurinol
Drug: Placebo Matching Canakinumab
Drug: Placebo Matching Colchicine
Core study: Canakinumab q4wk
Experimental
Canakinumab 50 mg sc at Days 1, and 29 followed by canakinumab 25 mg sc on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
Drug: Canakinumab
Drug: Allopurinol
Drug: Placebo Matching Colchicine
Core study: Colchicine 0.5 mg
Active Comparator
Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
Drug: Colchicine
Drug: Allopurinol
Drug: Placebo Matching Canakinumab
Extension study: Group A
Experimental
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Drug: Canakinumab
Extension study: Group B
Experimental
Patients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study.
Drug: Canakinumab
Extension study: Group C
Experimental
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Drug: Canakinumab
Drug: Colchicine
Extension study: Group D
Experimental
Patients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study.
Drug: Colchicine
Core study: Canakinumab 300 mg
Core study: Canakinumab 50 mg
Core study: Canakinumab q4wk
Extension study: Group A
Extension study: Group B
Extension study: Group C
Colchicine
Drug
0.5 mg capsule orally once daily for 16 weeks.
Core study: Colchicine 0.5 mg
Extension study: Group C
Extension study: Group D
Allopurinol
Drug
100-300 mg orally once daily for 24 weeks.
Core study: Canakinumab 100 mg
Core study: Canakinumab 200 mg
Core study: Canakinumab 25 mg
Core study: Canakinumab 300 mg
Core study: Canakinumab 50 mg
Core study: Canakinumab q4wk
Core study: Colchicine 0.5 mg
Placebo Matching Canakinumab
Drug
Subcutaneous injection.
Core study: Canakinumab 100 mg
Core study: Canakinumab 200 mg
Core study: Canakinumab 25 mg
Core study: Canakinumab 300 mg
Core study: Canakinumab 50 mg
Core study: Colchicine 0.5 mg
Placebo Matching Colchicine
Drug
Capsule orally once daily for 16 weeks.
Core study: Canakinumab 100 mg
Core study: Canakinumab 200 mg
Core study: Canakinumab 25 mg
Core study: Canakinumab 300 mg
Core study: Canakinumab 50 mg
Core study: Canakinumab q4wk
The percentage of participants experiencing at least 1 gout flare within 16 weeks after randomization. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Baseline of the core study to Week 16
Core Study: Percentage of Participants With Gout Flare at Different Time Points
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study
Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares
Participants rated the intensity of pain in the most affected joint on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.
Baseline of the core study to Week 16
Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares
Participants assessed the intensity of pain in the most affected joint on a 5-point Likert scale, which ranged from 1 to 5 (1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.
Baseline of the core study to Week 16
Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale
The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at Days 15, 29, 57, 85, 113, and 141. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.
Days 15, 29, 57, 85, 113, and 141 of the core study
Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare
Participant's rated the intensity of pain in the most affected joint during the first flare on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Assessments were made pre-dose and 24 hours, 3 days, 4 days, and an average of 5-7 days post-dose
Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)
Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale
Study participants made a global assessment of their response to treatment on a 5-point Likert scale (Excellent, Good, Acceptable, Slight, Poor) at the control visit 7±2 days following each of their first 3 flares. The number of participants in each of the 5 categories of the Likert scale are reported.
Baseline of the extension study until the end of the study (up to 24 weeks)
Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale
The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at the control visit 7±2 days following each of the first 3 flares. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.
Baseline of the extension study until the end of the study (up to 24 weeks)
Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare
Tenderness was rated on a 0-3 point scale: 0="no pain", 1=patient states that "there is pain", 2=patient states "there is pain and winces", and 3=patient states "there is pain, winces and withdraws" on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.
Baseline of the extension study until the end of the study (up to 24 weeks)
Extension Study: Amount of Rescue Medication Taken
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
Baseline of the extension study until the end of the study (up to 24 weeks)
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
FG002
Core Study: Canakinumab 100 mg
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
FG003
Core Study: Canakinumab 200 mg
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
FG004
Core Study: Canakinumab 300 mg
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
FG005
Core Study: Canakinumab q4wk
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
FG006
Core Study: Colchicine 0.5 mg
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
FG007
Extension Study: Group A
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
FG008
Extension Study: Group B
Patients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study.
FG009
Extension Study: Group C
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
FG010
Extension Study: Group D
Patients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study.
FG00055 subjectsParticipants who started the core study are included in the randomized and full analysis sets.
FG00154 subjects
FG00254 subjects
FG00354 subjects
FG00453 subjects
FG00554 subjects
FG006108 subjects
FG0070 subjectsThere were no participants in this arm during the core study.
FG0080 subjectsThere were no participants in this arm during the core study.
FG0090 subjectsThere were no participants in this arm during the core study.
FG0100 subjectsThere were no participants in this arm during the core study.
Received Study Medication
FG00055 subjectsParticipants who received study medication are included in the safety population.
FG00154 subjects
FG00254 subjects
FG00354 subjects
FG00453 subjects
FG00553 subjectsOne participant in this treatment arm was HIV+ve and did not receive any study medication.
FG006108 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
FG00049 subjects
FG00148 subjects
FG00248 subjects
FG00349 subjects
FG00450 subjects
FG00552 subjects
FG00695 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0035 subjects
FG0043 subjects
FG0052 subjects
FG00613 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0034 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Abnormal Laboratory Value(s)
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Unsatisfactory Therapeutic Effect
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject No Longer Requires Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Subject Withdrew Consent
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Administrative Problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Extension Study
Type
Comment
Milestone Data
STARTED
FG0000 subjectsThere were no participants in this arm during the extension study.
FG0010 subjectsThere were no participants in this arm during the extension study.
FG0020 subjectsThere were no participants in this arm during the extension study.
FG0030 subjectsThere were no participants in this arm during the extension study.
FG0040 subjectsThere were no participants in this arm during the extension study.
FG0050 subjectsThere were no participants in this arm during the extension study.
FG0060 subjectsThere were no participants in this arm during the extension study.
FG00775 subjects
FG008181 subjects
FG00925 subjects
FG01060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Abnormal Laboratory Value(s)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Baseline Characteristics of the reporting groups are based on the safety set, which included all participants who received study medication. Of the 432 participants enrolled in the core study, 1 participant did not receive any study medication and was not included in the safety set.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Core Study: Canakinumab 25 mg
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
BG001
Core Study: Canakinumab 50 mg
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
BG002
Core Study: Canakinumab 100 mg
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
BG003
Core Study: Canakinumab 200 mg
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
BG004
Core Study: Canakinumab 300 mg
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
BG005
Core Study: Canakinumab q4wk
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
BG006
Core Study: Colchicine 0.5 mg
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00055
BG00154
BG00254
BG00354
BG00453
BG00553
BG006108
BG007431
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00050.7± 9.72
BG00154.4± 12.18
BG00251.3± 12.41
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab
The Full Analysis Set (FAS) consisted of all patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.
Posted
Least Squares Mean
Standard Error
gout flares per patient
up to 16 weeks after randomization
ID
Title
Description
OG000
Canakinumab 25 mg
Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
OG001
Canakinumab 50 mg
Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
OG002
Canakinumab 100 mg
Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
OG003
Canakinumab 200 mg
Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
OG004
Canakinumab 300 mg
Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
OG005
Canakinumab q4wk
Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
Units
Counts
Participants
OG00055
OG00154
OG00254
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.48± 0.204
OG0010.43± 0.207
OG0020.22± 0.209
OG003
Secondary
Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization
The percentage of participants experiencing at least 1 gout flare within 16 weeks after randomization. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Posted
Number
Percentage of participants
Baseline of the core study to Week 16
ID
Title
Description
OG000
Core Study: Canakinumab 25 mg
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG001
Core Study: Canakinumab 50 mg
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG002
Core Study: Canakinumab 100 mg
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Secondary
Core Study: Percentage of Participants With Gout Flare at Different Time Points
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Posted
Number
95% Confidence Interval
Percentage of participants
Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study
ID
Title
Description
OG000
Core Study: Canakinumab 25 mg
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG001
Core Study: Canakinumab 50 mg
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG002
Core Study: Canakinumab 100 mg
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Secondary
Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares
Participants rated the intensity of pain in the most affected joint on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Posted
Mean
Standard Deviation
Units on a scale
Baseline of the core study to Week 16
ID
Title
Description
OG000
Core Study: Canakinumab 25 mg
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG001
Core Study: Canakinumab 50 mg
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG002
Core Study: Canakinumab 100 mg
Secondary
Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares
Participants assessed the intensity of pain in the most affected joint on a 5-point Likert scale, which ranged from 1 to 5 (1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Posted
Mean
Standard Deviation
Units on a scale
Baseline of the core study to Week 16
ID
Title
Description
OG000
Core Study: Canakinumab 25 mg
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG001
Core Study: Canakinumab 50 mg
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG002
Core Study: Canakinumab 100 mg
Primary
Core Study: Mean Number of Gout Flares Per Participant
A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Posted
Mean
Standard Deviation
Gout flares
Baseline of the core study to Week 16
ID
Title
Description
OG000
Core Study: Canakinumab 25 mg
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG001
Core Study: Canakinumab 50 mg
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG002
Core Study: Canakinumab 100 mg
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
Secondary
Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale
The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at Days 15, 29, 57, 85, 113, and 141. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.
Full Analysis Set (FAS): All patients as randomized that had at least 1 post-baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned at randomization.
Posted
Number
Participants
Days 15, 29, 57, 85, 113, and 141 of the core study
ID
Title
Description
OG000
Core Study: Canakinumab 25 mg
Participants received canakinumab 25 mg subcutaneously (sc) on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG001
Core Study: Canakinumab 50 mg
Participants received canakinumab 50 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG002
Core Study: Canakinumab 100 mg
Secondary
Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare
Participant's rated the intensity of pain in the most affected joint during the first flare on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Assessments were made pre-dose and 24 hours, 3 days, 4 days, and an average of 5-7 days post-dose
Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
Posted
Mean
Standard Deviation
Units on a scale
Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)
ID
Title
Description
OG000
Extension Study: Group A
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
OG001
Extension Study: Group C
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Units
Counts
Participants
Secondary
Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale
Study participants made a global assessment of their response to treatment on a 5-point Likert scale (Excellent, Good, Acceptable, Slight, Poor) at the control visit 7±2 days following each of their first 3 flares. The number of participants in each of the 5 categories of the Likert scale are reported.
Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
Posted
Number
Participants
Baseline of the extension study until the end of the study (up to 24 weeks)
ID
Title
Description
OG000
Extension Study: Group A
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
OG001
Extension Study: Group C
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Units
Counts
Participants
Secondary
Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale
The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at the control visit 7±2 days following each of the first 3 flares. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.
Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
Posted
Number
Participants
Baseline of the extension study until the end of the study (up to 24 weeks)
ID
Title
Description
OG000
Extension Study: Group A
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
OG001
Extension Study: Group C
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Units
Counts
Participants
Secondary
Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare
Tenderness was rated on a 0-3 point scale: 0="no pain", 1=patient states that "there is pain", 2=patient states "there is pain and winces", and 3=patient states "there is pain, winces and withdraws" on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.
Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
Posted
Number
Participants
Baseline of the extension study until the end of the study (up to 24 weeks)
ID
Title
Description
OG000
Extension Study: Group A
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
OG001
Extension Study: Group C
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Secondary
Extension Study: Amount of Rescue Medication Taken
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
Efficacy set: All Group A and C participants who received at least 1 dose of canakinumab during the extension study.
Posted
Mean
Standard Deviation
mg
Baseline of the extension study until the end of the study (up to 24 weeks)
ID
Title
Description
OG000
Extension Study: Group A
Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.
OG001
Extension Study: Group C
Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.
Units
Counts
Participants
OG000
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Core Study: ACZ 25 mg
Core study: ACZ 25 mg
2
55
21
55
EG001
Core Study: ACZ 50 mg
Core study: ACZ 50 mg
2
54
15
54
EG002
Core Study: ACZ 100 mg
Core study: ACZ 100 mg
3
54
14
54
EG003
Core Study: ACZ 200 mg
Core study: ACZ 200 mg
3
54
14
54
EG004
Core Study: ACZ 300 mg
Core study: ACZ 300 mg
3
53
15
53
EG005
Core Study: ACZ Q4wk mg
Core study: ACZ Q4wk mg
1
53
14
53
EG006
Core Study: Colch 0.5 mg
Core study: Colch 0.5 mg
6
108
21
108
EG007
Extension Study: Group A
Extension study: Group A
4
75
21
75
EG008
Extension Study: Group B
Extension study: Group B
6
181
19
181
EG009
Extension Study: Group C
Extension study: Group C
0
25
6
25
EG010
Extension Study: Group D
Extension study: Group D
1
60
4
60
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG0031 affected54 at risk
EG0040 affected53 at risk
EG0050 affected53 at risk
EG0060 affected108 at risk
EG0070 affected75 at risk
EG0080 affected181 at risk
EG0090 affected25 at risk
EG0100 affected60 at risk
Angina pectoris
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Myocardial fibrosis
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected54 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Erysipelas
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Gangrene
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Heat exhaustion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Meniscus lesion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Gouty tophus
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected54 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Stupor
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected54 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected54 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected54 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 affected55 at risk
EG0011 affected54 at risk
EG0022 affected54 at risk
EG0033 affected54 at risk
EG0041 affected53 at risk
EG0050 affected53 at risk
EG0062 affected108 at risk
EG0072 affected75 at risk
EG0081 affected181 at risk
EG0090 affected25 at risk
EG0100 affected60 at risk
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected55 at risk
EG0011 affected54 at risk
EG0023 affected54 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0005 affected55 at risk
EG0012 affected54 at risk
EG0022 affected54 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected55 at risk
EG0011 affected54 at risk
EG0022 affected54 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0003 affected55 at risk
EG0011 affected54 at risk
EG0020 affected54 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0003 affected55 at risk
EG0011 affected54 at risk
EG0020 affected54 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0004 affected55 at risk
EG0015 affected54 at risk
EG0024 affected54 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0003 affected55 at risk
EG0013 affected54 at risk
EG0021 affected54 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0004 affected55 at risk
EG0013 affected54 at risk
EG0021 affected54 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0022 affected54 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected55 at risk
EG0011 affected54 at risk
EG0020 affected54 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0006 affected55 at risk
EG0012 affected54 at risk
EG0022 affected54 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
ID
Term
D006073
Gout
D015210
Arthritis, Gouty
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D000070657
Crystal Arthropathies
D012216
Rheumatic Diseases
D011686
Purine-Pyrimidine Metabolism, Inborn Errors
D008661
Metabolism, Inborn Errors
D030342
Genetic Diseases, Inborn
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C541220
canakinumab
D003078
Colchicine
D000493
Allopurinol
Ancestor Terms
ID
Term
D000470
Alkaloids
D006571
Heterocyclic Compounds
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0063 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
1 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0051 subjects
FG0063 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG00775 subjects
FG008173 subjects
FG00924 subjects
FG01058 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0088 subjects
FG0091 subjects
FG0102 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
Subject Withdrew Consent
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0083 subjects
FG0090 subjects
FG0101 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
FG0101 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
52.6
± 10.78
BG00452.4± 11.30
BG00552.8± 10.38
BG00652.4± 10.69
BG00752.4± 11.02
6
BG0034
BG0042
BG0054
BG0067
BG00726
Male
BG00055
BG00151
BG00248
BG00350
BG00451
BG00549
BG006101
BG007405
54
OG00453
OG00554
0.38
± 0.205
OG0040.21± 0.209
OG0050.68± 0.209
OG003
Core Study: Canakinumab 200 mg
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG004
Core Study: Canakinumab 300 mg
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG005
Core Study: Canakinumab q4wk
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
OG006
Core Study: Colchicine 0.5 mg
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Units
Counts
Participants
OG00055
OG00154
OG00254
OG00354
OG00453
OG00554
OG006108
Title
Denominators
Categories
Title
Measurements
OG00027.3
OG00116.7
OG00214.8
OG00318.5
OG00415.1
OG00516.7
OG00644.4
OG003
Core Study: Canakinumab 200 mg
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG004
Core Study: Canakinumab 300 mg
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG005
Core Study: Canakinumab q4wk
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
OG006
Core Study: Colchicine 0.5 mg
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Units
Counts
Participants
OG00055
OG00154
OG00254
OG00354
OG00453
OG00554
OG006108
Title
Denominators
Categories
2 days post-dose
Title
Measurements
OG0005.5(1.79 to 15.96)
OG0013.7(0.94 to 14.01)
OG0023.7(0.94 to 14.01)
OG0033.7(0.94 to 14.01)
OG0040.0(0.0 to 0.0)
OG0053.8(0.96 to 14.26)
OG0065.6(2.53 to 11.95)
4 days post-dose
Title
Measurements
OG00010.9(5.05 to 22.68)
OG0013.7(0.94 to 14.01)
OG0023.7(0.94 to 14.01)
OG003
6 days post-dose
Title
Measurements
OG00012.7(6.28 to 24.85)
OG0015.6(1.83 to 16.24)
OG0023.7(0.94 to 14.01)
OG003
2 weeks post-dose
Title
Measurements
OG00014.5(7.55 to 26.99)
OG0017.4(2.85 to 18.54)
OG0027.4(2.85 to 18.54)
OG003
4 weeks post-dose
Title
Measurements
OG00014.5(7.55 to 26.99)
OG0019.3(3.96 to 20.83)
OG0027.4(2.85 to 18.54)
OG003
6 weeks post-dose
Title
Measurements
OG00016.5(8.96 to 29.39)
OG00111.1(5.15 to 23.07)
OG0029.3(3.98 to 20.91)
OG003
10 weeks post-dose
Title
Measurements
OG00022.5(13.43 to 36.26)
OG00113.1(6.46 to 25.52)
OG00211.2(5.19 to 23.22)
OG003
16 weeks post-dose
Title
Measurements
OG00028.7(18.34 to 43.10)
OG00117.3(9.37 to 30.66)
OG00215.1(7.82 to 27.87)
OG003
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG003
Core Study: Canakinumab 200 mg
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG004
Core Study: Canakinumab 300 mg
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG005
Core Study: Canakinumab q4wk
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
OG006
Core Study: Colchicine 0.5 mg
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Units
Counts
Participants
OG00055
OG00154
OG00254
OG00354
OG00453
OG00554
OG006108
Title
Denominators
Categories
Day 1 (n=15, 9, 8, 9, 8, 9, 48)
Title
Measurements
OG00041.1± 31.01
OG00144.6± 15.82
OG00256.3± 26.72
OG00353.0± 27.99
OG00452.2± 19.40
OG00566.1± 15.07
OG00653.1± 24.18
Day 2 (n=12, 7, 6, 5, 5, 7, 44)
Title
Measurements
OG00044.8± 30.06
OG00140.1± 26.73
OG00246.2± 35.11
OG003
Day 3 (n=10, 4, 4, 4, 4, 5, 38)
Title
Measurements
OG00031.5± 20.82
OG00149.5± 18.48
OG00249.5± 25.29
OG003
Day 4 (n=7, 3, 2, 3, 3, 6, 31)
Title
Measurements
OG00031.8± 16.77
OG00146.3± 10.60
OG00216.5± 23.33
OG003
Day 5 (n=7, 2, 1, 3, 2, 4, 22)
Title
Measurements
OG00019.3± 14.79
OG00148.0± 5.66
OG0020.0± 0.0
OG003
Day 6 (n=6, 1, 1, 2, 1, 3, 18)
Title
Measurements
OG00019.6± 14.14
OG00144.0± 0.0
OG0020.0± 0.0
OG003
Day 7 (n=6, 0, 1, 2, 1, 2, 16)
Title
Measurements
OG00020.9± 16.91
OG001NA± NANo data is available
OG0020.0± 0.0
OG003
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG003
Core Study: Canakinumab 200 mg
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG004
Core Study: Canakinumab 300 mg
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG005
Core Study: Canakinumab q4wk
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
OG006
Core Study: Colchicine 0.5 mg
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Units
Counts
Participants
OG00055
OG00154
OG00254
OG00354
OG00453
OG00554
OG006108
Title
Denominators
Categories
Day 1 (n=15, 8, 8, 9, 8, 9, 48)
Title
Measurements
OG0002.8± 0.88
OG0013.1± 0.65
OG0023.5± 1.20
OG0033.2± 0.92
OG0043.1± 0.35
OG0053.8± 0.60
OG0063.2± 0.77
Day 2 (n=12, 6, 6, 5, 5, 7, 44)
Title
Measurements
OG0002.9± 0.92
OG0012.6± 1.02
OG0023.3± 1.51
OG003
Day 3 (n=10, 4, 4, 4, 4, 6, 38)
Title
Measurements
OG0002.4± 0.73
OG0013.1± 0.63
OG0022.3± 0.96
OG003
Day 4 (n=7, 3, 2, 3, 3, 7, 31)
Title
Measurements
OG0002.6± 0.57
OG0012.7± 0.58
OG0021.5± 0.71
OG003
Day 5 (n=7, 2, 1, 3, 2, 4, 22)
Title
Measurements
OG0002.2± 0.69
OG0012.5± 0.71
OG0021.0± 0
OG003
Day 6 (n=6, 1, 1, 2, 2, 3, 18)
Title
Measurements
OG0002.4± 0.49
OG0013.0± 0.0
OG0021.0± 0.0
OG003
Day 7 (n=6, 0, 1, 2, 1, 2, 16)
Title
Measurements
OG0002.4± 0.49
OG001NA± NANo participants analyzed.
OG0021.0± 0.0
OG003
OG003
Core Study: Canakinumab 200 mg
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG004
Core Study: Canakinumab 300 mg
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG005
Core Study: Canakinumab q4wk
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
OG006
Core Study: Colchicine 0.5 mg
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Units
Counts
Participants
OG00055
OG00154
OG00254
OG00354
OG00453
OG00554
OG006108
Title
Denominators
Categories
Title
Measurements
OG0000.5± 1.03
OG0010.4± 1.82
OG0020.2± 0.53
OG0030.4± 1.35
OG0040.2± 0.53
OG0050.7± 2.24
OG0060.7± 1.00
Participants received canakinumab 100 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG003
Core Study: Canakinumab 200 mg
Participants received canakinumab 200 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG004
Core Study: Canakinumab 300 mg
Participants received canakinumab 300 mg sc on Day 1; canakinumab placebo sc on Days 29, 57, and 85; and colchicine placebo orally once daily for 16 weeks.
OG005
Core Study: Canakinumab q4wk
Participants received canakinumab 50 mg sc on Days 1 and 29; canakinumab 25 mg sc on Days 57 and 85; and colchicine placebo orally once daily for 16 weeks.
OG006
Core Study: Colchicine 0.5 mg
Participants received colchicine 0.5 mg orally once daily for 16 weeks and canakinumab placebo sc on Days 1, 29, 57, and 85.
Units
Counts
Participants
OG00055
OG00154
OG00254
OG00354
OG00453
OG00554
OG006108
Title
Denominators
Categories
Day 15: Very good
Title
Measurements
OG00019
OG00123
OG00224
OG00323
OG00427
OG00525
OG00640
Day 15 - Good
Title
Measurements
OG00028
OG00124
OG00223
OG003
Day 15 - Fair
Title
Measurements
OG0005
OG0014
OG0023
OG003
Day 15 - Poor
Title
Measurements
OG0000
OG0010
OG0022
OG003
Day 15 - Very poor
Title
Measurements
OG0000
OG0011
OG0020
OG003
Day 15 - Not assessed
Title
Measurements
OG0003
OG0011
OG0021
OG003
Day 29: Very good
Title
Measurements
OG00026
OG00124
OG00225
OG003
Day 29- Good
Title
Measurements
OG00023
OG00122
OG00222
OG003
Day 29 - Fair
Title
Measurements
OG0002
OG0014
OG0025
OG003
Day 29 - Poor
Title
Measurements
OG0000
OG0010
OG0021
OG003
Day 29 - Very poor
Title
Measurements
OG0000
OG0011
OG0020
OG003
Day 29 - Not assessed
Title
Measurements
OG0000
OG0013
OG0020
OG003
Day 57: Very good
Title
Measurements
OG00025
OG00127
OG00228
OG003
Day 57- Good
Title
Measurements
OG00021
OG00120
OG00216
OG003
Day 57 - Fair
Title
Measurements
OG0005
OG0013
OG0026
OG003
Day 57 - Poor
Title
Measurements
OG0000
OG0010
OG0022
OG003
Day 57 - Very poor
Title
Measurements
OG0000
OG0011
OG0020
OG003
Day 57 - Not assessed
Title
Measurements
OG0000
OG0012
OG0021
OG003
Day 85: Very good
Title
Measurements
OG00027
OG00131
OG00232
OG003
Day 85 - Good
Title
Measurements
OG00020
OG00117
OG00215
OG003
Day 85 - Fair
Title
Measurements
OG0003
OG0012
OG0025
OG003
Day 85 - - Poor
Title
Measurements
OG0000
OG0010
OG0021
OG003
Day 85 - Very poor
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 85 - Not assessed
Title
Measurements
OG0001
OG0012
OG0020
OG003
Day 113 : Very good
Title
Measurements
OG00024
OG00129
OG00230
OG003
Day 113 - Good
Title
Measurements
OG00018
OG00118
OG00218
OG003
Day 113 - Fair
Title
Measurements
OG0005
OG0013
OG0022
OG003
Day 113 - Poor
Title
Measurements
OG0002
OG0010
OG0021
OG003
Day 113 - Very poor
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 113 - Not Assessed
Title
Measurements
OG0000
OG0012
OG0020
OG003
Day 141 : Very good
Title
Measurements
OG00026
OG00125
OG00224
OG003
Day 141 - Good
Title
Measurements
OG00016
OG00120
OG00219
OG003
Day 141 - Fair
Title
Measurements
OG0006
OG0012
OG0023
OG003
Day 141 - Poor
Title
Measurements
OG0001
OG0011
OG0023
OG003
Day 141 - Very poor
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 141 - Not Assessed
Title
Measurements
OG0000
OG0013
OG0021
OG003
OG00065
OG00119
Title
Denominators
Categories
Pre-dose (n=65, 19)
Title
Measurements
OG00061.3± 27.13
OG00171.8± 20.86
24 hours (n=65, 18)
Title
Measurements
OG00023.8± 23.32
OG00129.0± 22.85
3 days (n=54, 15)
Title
Measurements
OG00012.4± 16.82
OG0016.8± 9.03
4 days (n=54, 15)
Title
Measurements
OG0008.8± 14.32
OG0012.7± 5.06
5-7 days (n=52, 13)
Title
Measurements
OG0008.1± 15.86
OG0012.1± 4.70
OG00063
OG00121
Title
Denominators
Categories
Gout Flare 1: Excellent (63, 21)
Title
Measurements
OG00040
OG0017
Gout Flare 1: Good (63, 21)
Title
Measurements
OG00017
OG00114
Gout Flare 1: Acceptable (63, 21)
Title
Measurements
OG0005
OG0010
Gout Flare 1: Slight (63, 21)
Title
Measurements
OG0001
OG0010
Gout Flare 1: Poor (63, 21)
Title
Measurements
OG0000
OG0010
Gout Flare 2: Excellent (11, 5)
Title
Measurements
OG0004
OG0014
Gout Flare 2: Good (11, 5)
Title
Measurements
OG0006
OG0011
Gout Flare 2: Acceptable (11, 5)
Title
Measurements
OG0001
OG0010
Gout Flare 2: Slight (11, 5)
Title
Measurements
OG0000
OG0010
Gout Flare 2: Poor (11, 5)
Title
Measurements
OG0000
OG0010
Gout Flare 3: Excellent (3, 1)
Title
Measurements
OG0002
OG0010
Gout Flare 3: Good (3, 1)
Title
Measurements
OG0001
OG0011
Gout Flare 3: Acceptable (3, 1)
Title
Measurements
OG0000
OG0010
Gout Flare 3: Slight (3, 1)
Title
Measurements
OG0000
OG0010
Gout Flare 3: Poor (3, 1)
Title
Measurements
OG0000
OG0010
OG00069
OG00123
Title
Denominators
Categories
Gout Flare 1: Very Good (69, 23)
Title
Measurements
OG00037
OG00113
Gout Flare 1: Good (69, 23)
Title
Measurements
OG00028
OG00110
Gout Flare 1: Fair (69, 23)
Title
Measurements
OG0002
OG0010
Gout Flare 1: Poor (69, 23)
Title
Measurements
OG0002
OG0010
Gout Flare 1: Very Poor (69, 23)
Title
Measurements
OG0000
OG0010
Gout Flare 2: Very Good (12, 5)
Title
Measurements
OG0005
OG0013
Gout Flare 2: Good (12, 5)
Title
Measurements
OG0007
OG0012
Gout Flare 2: Fair (12, 5)
Title
Measurements
OG0000
OG0010
Gout Flare 2: Poor (12, 5)
Title
Measurements
OG0000
OG0010
Gout Flare 2: Very Poor (12, 5)
Title
Measurements
OG0000
OG0010
Gout Flare 3: Very Good (3, 1)
Title
Measurements
OG0001
OG0010
Gout Flare 3: Good (3, 1)
Title
Measurements
OG0002
OG0011
Gout Flare 3: Fair (3, 1)
Title
Measurements
OG0000
OG0010
Gout Flare 3: Poor (3, 1)
Title
Measurements
OG0000
OG0010
Gout Flare 3: Very Poor (3, 1)
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG00069
OG00124
Title
Denominators
Categories
Tenderness Flare Visit: No pain
Title
Measurements
OG0002
OG0010
Tenderness Flare Visit: Pain
Title
Measurements
OG00027
OG0012
Tenderness Flare Visit: Pain and winces
Title
Measurements
OG00023
OG00110
Tenderness Flare Visit: Pain, winces and withdraws
Title
Measurements
OG00017
OG00112
Tenderness Control Visit: No pain
Title
Measurements
OG00060
OG00121
Tenderness Control Visit: Pain
Title
Measurements
OG0008
OG0013
Tenderness Control Visit: Pain and winces
Title
Measurements
OG0001
OG0010
Tenderness Control Visit: Pain, winces and withdra
Title
Measurements
OG0000
OG0010
Joint Swelling Flare Visit: No swelling
Title
Measurements
OG0005
OG0010
Joint Swelling Flare Visit: Palpable
Title
Measurements
OG00020
OG0012
Joint Swelling Flare Visit: Visible
Title
Measurements
OG00031
OG00117
Joint Swelling Flare Visit: Bulging beyond joint
Title
Measurements
OG00013
OG0015
Joint Swelling Control Visit: No swelling
Title
Measurements
OG00061
OG00122
Joint Swelling Control Visit: Palpable
Title
Measurements
OG0006
OG0012
Joint Swelling Control Visit: Visible
Title
Measurements
OG0002
OG0010
Joint Swelling Control Visit: Bulging beyond joint