Long Term Study of Canakinumab (ACZ885) in Patients With... | NCT00927810 | Trialant
NCT00927810
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jul 2, 2021Actual
Enrollment
341Actual
Phase
Phase 2
Conditions
Gouty Arthritis
Interventions
Canakinumab
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
NCT00927810
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CACZ885H2251E1
Secondary IDs
Not provided
Brief Title
Long Term Study of Canakinumab (ACZ885) in Patients With Gout
Official Title
A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Were Given Canakinumab at the Time of Gout Flare
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2021
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
Jun 5, 2009Actual
Primary Completion Date
Aug 4, 2010Actual
Completion Date
Aug 4, 2010Actual
First Submitted Date
Jun 23, 2009
First Submission Date that Met QC Criteria
Jun 24, 2009
First Posted Date
Jun 25, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
May 13, 2021
Results First Submitted that Met QC Criteria
May 13, 2021
Results First Posted Date
Jun 9, 2021Actual
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 10, 2021
Last Update Posted Date
Jul 2, 2021Actual
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
This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.
Detailed Description
Not provided
Conditions Module
Conditions
Gouty Arthritis
Keywords
Gouty
Gouty arthritis
Gout flares
Anti-interleukin-1β monoclonal antibody
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
341Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
canakinumab
Experimental
Drug: Canakinumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Canakinumab
Drug
canakinumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events and Serious Adverse Events
Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards
From start of study up to study completion (up to 14 months)
Secondary Outcomes
Measure
Description
Time Frame
Difference Change From Baseline in Participant's Gout Pain During First Flare
Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported.
Baseline and Day 7
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients who completed the core study CACZ885H2251. 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 1 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).
Female patients who were physiologically capable of becoming pregnant, unless they were:
Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner.
Female patients whose partners had been sterilized by vasectomy or other means.
Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1.
Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation.
Other protocol defined inclusion/exclusion criteria may apply
Schlesinger N, Mysler E, Lin HY, De Meulemeester M, Rovensky J, Arulmani U, Balfour A, Krammer G, Sallstig P, So A. Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study. Ann Rheum Dis. 2011 Jul;70(7):1264-71. doi: 10.1136/ard.2010.144063. Epub 2011 May 3.
See Also Links
Not provided
Available IPD Information
Not provided
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 341 participants enrolled in the study, out of which 330 participants completed the study.
Recruitment Details
The study was conducted at 75 centers in 18 countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Core: Canakinumab, Extension: 150 mg Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome.
24 weeks
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome.
24 weeks
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group
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.
24 weeks
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
24 weeks
Capital Federal Buenos Aires
1027
Argentina
Novartis Investigative site
Jette
1090
Belgium
Novartis Investigative site
Barranquilla
Colombia
Novartis Investigative site
Bogotá
Colombia
Novartis Investigative site
Bucaramanga
Colombia
Novartis Investigative site
Floridablanca
Colombia
Novartis Investigative site
Prague
Czech Republic
15006
Czechia
Novartis Investigative site
Sachsen
Dresden / Schützenhöhe 16
D-01099
Germany
Novartis Investigative site
Bayern
München / Mühlbaurstraße 16
D-81677
Germany
Novartis Investigative site
Dessau
Roßlau / Kühnauer Straße 70 Sachsen- Anhalt
D-06846
Germany
Novartis Investigative site
Guatemala City
01015
Guatemala
Novartis Investigative site
Debrecen
Bartók B U 2-26
4043
Hungary
Novartis Investigative site
Kistarcsa
Semmelweis Tér 1.
2143
Hungary
Novartis Investigative site
Eger
Széchenyi U 27-29
3301
Hungary
Novartis Investigative site
Zalaegerszeg
Zrínyi U 1
8900
Hungary
Novartis Investigative site
Poznan
NA 61- 734
Poland
Novartis Investigative site
Wroclaw
NA 50-333
Poland
Novartis Investigative site
Lisbon
1749-004
Portugal
Novartis Investigative site
Chelyabinsk
454047
Russia
Novartis Investigative site
Moscow
115522
Russia
Novartis Investigative site
Moscow
127473
Russia
Novartis Investigative site
Petrozavodsk
Russia
Novartis Investigative site
Saint Petersburg
190068
Russia
Novartis Investigative site
Saint Petersburg
193015
Russia
Novartis Investigative site
Yaroslavl
150003
Russia
Novartis Investigative site
Singapore
169611
Singapore
Novartis Investigative site
Bratislava
N/A 813 69
Slovakia
Novartis Investigative site
Košice
N/A 042 66
Slovakia
Novartis Investigative site
Nitra
N/A 949 01
Slovakia
Novartis Investigative site
Piešťany
N/A 921 12
Slovakia
Novartis Investigative site
Trenčín
N/A 911 50
Slovakia
Novartis Investigative site
Pretoria
Gauteng
0153
South Africa
Novartis Investigative site
Madrid
28046
Spain
Novartis Investigative site
Kaohsiung City
80756
Taiwan
Novartis Investigative site
Kaohsiung City
81346
Taiwan
Novartis Investigative site
Taichung
40705
Taiwan
Novartis Investigative site
Taipei
11217
Taiwan
Novartis Investigative site
Ankara
Bahcellievler
06490
Turkey (Türkiye)
Novartis Investigative site
Adana
Balcali
01330
Turkey (Türkiye)
Novartis Investigative site
Izmir
Inciraltı
35340
Turkey (Türkiye)
Novartis Investigative site
Aydin
Merkez
09100
Turkey (Türkiye)
Novartis Investigative site
Manisa
Merkez
45010
Turkey (Türkiye)
Novartis Investigative site
Gaziantep
Sehitkamil
27310
Turkey (Türkiye)
Novartis Investigative site
Jarrow
Tyne & Wear
NE32 3DT
United Kingdom
Core: Canakinumab, Extension: No Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
FG002
Core: Colchicine, Extension: 150 mg Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single SC dose of 150 mg Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
FG003
Core: Colchicine, Extension: No Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not receive canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
FG00075 subjects
FG001181 subjects
FG00225 subjects
FG00360 subjects
COMPLETED
FG00075 subjects
FG001173 subjects
FG00224 subjects
FG00358 subjects
NOT COMPLETED
FG0000 subjects
FG0018 subjects
FG0021 subjects
FG0032 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0031 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
Death
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Abnormal laboratory value(s)
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Core: Canakinumab, Extension: 150 mg Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
BG001
Core: Canakinumab, Extension: No Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
BG002
Core: Colchicine, Extension: 150 mg Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
BG003
Core: Colchicine, Extension: No Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00075
BG001181
BG00225
BG00360
BG004341
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± 10.20
BG00153.8± 11.39
BG00252.0± 11.00
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG00113
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG00046
BG001143
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
Primary
Number of Participants With Adverse Events and Serious Adverse Events
Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards
Safety Set 1 consisted of all participants from the core study who entered the extension study.
Posted
Count of Participants
Participants
From start of study up to study completion (up to 14 months)
ID
Title
Description
OG000
Core: Canakinumab, Extension: 150 mg Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
OG001
Core: Canakinumab, Extension: No Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
OG002
Core: Colchicine, Extension: 150 mg Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
OG003
Core: Colchicine, Extension: No Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
Units
Counts
Participants
OG00075
OG001181
OG00225
OG003
Title
Denominators
Categories
Title
Measurements
OG00031
OG00152
OG0029
OG003
Secondary
Difference Change From Baseline in Participant's Gout Pain During First Flare
Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported.
Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Day 7
ID
Title
Description
OG000
Core: Canakinumab, Extension: 150 mg Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
OG001
Core: Colchicine, Extension: 150 mg Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
Secondary
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome.
Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
Core: Canakinumab, Extension: 150 mg Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
OG001
Core: Colchicine, Extension: 150 mg Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
Secondary
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome.
Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
Core: Canakinumab, Extension: 150 mg Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
OG001
Core: Colchicine, Extension: 150 mg Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
Secondary
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group
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 consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
Core: Canakinumab, Extension: 150 mg Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
OG001
Core: Colchicine, Extension: 150 mg Canakinumab
Secondary
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
Efficacy Set consisted of all participants who received at least one dose of canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Posted
Mean
Standard Deviation
milligrams (mg)
24 weeks
ID
Title
Description
OG000
Core: Canakinumab, Extension: 150 mg Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
OG001
Core: Colchicine, Extension: 150 mg Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
Time Frame
From start of study up to study completion (up to 14 months)
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: 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.
0
55
2
55
21
55
EG001
Core: 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.
0
54
2
54
15
54
EG002
Core: 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.
0
54
3
54
14
54
EG003
Core: 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.
0
54
3
54
14
54
EG004
Core: 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.
0
53
3
53
15
53
EG005
Core : Canakinumab Q4wk mg
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.
0
53
1
53
14
53
EG006
Core : 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.
1
108
6
108
21
108
EG007
Core: Canakinumab, Extension: 150 mg Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
0
75
4
75
21
75
EG008
Core: Canakinumab, Extension: No Canakinumab
Participants who were randomized to canakinumab in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
2
181
6
181
19
181
EG009
Core: Colchicine, Extension: 150 mg Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).
0
25
0
25
6
25
EG010
Core: Colchicine, Extension: No Canakinumab
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]) and who did not received canakinumab in this extension study (NCT00927810 [CACZ885H2251E1]).
0
60
1
60
4
60
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA (Unspecified)
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 (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Myocardial fibrosis
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected54 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Ear infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Gangrene
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Sepsis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Heat exhaustion
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Meniscus lesion
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Gouty tophus
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected54 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
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 (Unspecified)
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 (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Stupor
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected54 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected54 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected54 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (Unspecified)
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 (Unspecified)
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 (Unspecified)
Systematic Assessment
EG0002 affected55 at risk
EG0011 affected54 at risk
EG0023 affected54 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0005 affected55 at risk
EG0012 affected54 at risk
EG0022 affected54 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (Unspecified)
Systematic Assessment
EG0002 affected55 at risk
EG0011 affected54 at risk
EG0022 affected54 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0003 affected55 at risk
EG0011 affected54 at risk
EG0020 affected54 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (Unspecified)
Systematic Assessment
EG0003 affected55 at risk
EG0011 affected54 at risk
EG0020 affected54 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0004 affected55 at risk
EG0015 affected54 at risk
EG0024 affected54 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0003 affected55 at risk
EG0013 affected54 at risk
EG0021 affected54 at risk
EG003
Headache
Nervous system disorders
MedDRA (Unspecified)
Systematic Assessment
EG0004 affected55 at risk
EG0013 affected54 at risk
EG0021 affected54 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0022 affected54 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected54 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (Unspecified)
Systematic Assessment
EG0001 affected55 at risk
EG0011 affected54 at risk
EG0020 affected54 at risk
EG003
Hypertension
Vascular disorders
MedDRA (Unspecified)
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 (i.e., data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
+1 (862) 778-8300
novartis.email@novartis.com
ID
Term
D015210
Arthritis, Gouty
Ancestor Terms
ID
Term
D006073
Gout
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
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
51.5
± 9.45
BG00452.6± 10.83
0
BG0037
BG00422
Male
BG00073
BG001168
BG00225
BG00353
BG004319
19
BG00349
BG004257
Black
Title
Measurements
BG0002
BG0016
BG0021
BG0031
BG00410
Asian
Title
Measurements
BG00011
BG00110
BG0022
BG0032
BG00425
Native American
Title
Measurements
BG0001
BG0013
BG0020
BG0031
BG0045
Pacific islander
Title
Measurements
BG0000
BG0010
BG0020
BG0032
BG0042
Other
Title
Measurements
BG00015
BG00119
BG0023
BG0035
BG00442
60
15
Units
Counts
Participants
OG00052
OG00113
Title
Denominators
Categories
Title
Measurements
OG000-51.7± 15.86
OG001-67.4± 21.69
Units
Counts
Participants
OG00063
OG00121
Title
Denominators
Categories
1. Gout Flare: Excellent
ParticipantsOG00063
ParticipantsOG00121
Title
Measurements
OG00040
OG0017
1. Gout Flare: Good
ParticipantsOG00063
ParticipantsOG00121
Title
Measurements
OG00017
OG001
1. Gout Flare: Acceptable
ParticipantsOG00063
ParticipantsOG00121
Title
Measurements
OG0005
OG001
1. Gout Flare: Slight
ParticipantsOG00063
ParticipantsOG00121
Title
Measurements
OG0001
OG001
1. Gout Flare: Poor
ParticipantsOG00063
ParticipantsOG00121
Title
Measurements
OG0000
OG001
2. Gout Flare: Excellent
ParticipantsOG00011
ParticipantsOG0015
Title
Measurements
OG0004
OG001
2. Gout Flare: Good
ParticipantsOG00011
ParticipantsOG0015
Title
Measurements
OG0006
OG001
2. Gout Flare: Acceptable
ParticipantsOG00011
ParticipantsOG0015
Title
Measurements
OG0001
OG001
2. Gout Flare: Slight
ParticipantsOG00011
ParticipantsOG0015
Title
Measurements
OG0000
OG001
2. Gout Flare: Poor
ParticipantsOG00011
ParticipantsOG0015
Title
Measurements
OG0000
OG001
3. Gout Flare: Excellent
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0002
OG001
3. Gout Flare: Good
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0001
OG001
3. Gout Flare: Acceptable
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0000
OG001
3. Gout Flare: Slight
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0000
OG001
3. Gout Flare: Poor
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0000
OG001
Units
Counts
Participants
OG00069
OG00123
Title
Denominators
Categories
1. Gout Flare: Very Good
ParticipantsOG00069
ParticipantsOG00123
Title
Measurements
OG00037
OG00113
1. Gout Flare: Good
ParticipantsOG00069
ParticipantsOG00123
Title
Measurements
OG00028
OG001
1. Gout Flare: Fair
ParticipantsOG00069
ParticipantsOG00123
Title
Measurements
OG0002
OG001
1. Gout Flare: Poor
ParticipantsOG00069
ParticipantsOG00123
Title
Measurements
OG0002
OG001
1. Gout Flare: Very Poor
ParticipantsOG00069
ParticipantsOG00123
Title
Measurements
OG0000
OG001
2. Gout Flare: Very good
ParticipantsOG00012
ParticipantsOG0015
Title
Measurements
OG0005
OG001
2. Gout Flare: Good
ParticipantsOG00012
ParticipantsOG0015
Title
Measurements
OG0007
OG001
2. Gout Flare: Fair
ParticipantsOG00012
ParticipantsOG0015
Title
Measurements
OG0000
OG001
2. Gout Flare: Poor
ParticipantsOG00012
ParticipantsOG0015
Title
Measurements
OG0000
OG001
2. Gout Flare: Very poor
ParticipantsOG00012
ParticipantsOG0015
Title
Measurements
OG0000
OG001
3. Gout Flare: Very Good
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0001
OG001
3. Gout Flare: Good
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0002
OG001
3. Gout Flare: Fair
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0000
OG001
3. Gout Flare: Poor
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0000
OG001
3. Gout Flare: Very poor
ParticipantsOG0003
ParticipantsOG0011
Title
Measurements
OG0000
OG001
Participants who were randomized to colchicine in the core study (NCT00819585 [CACZ885H2251]), received single subcutaneous (SC) dose of 150 milligrams (mg) Canakinumab (ACZ885) for at least one flare in this extension study (NCT00927810 [CACZ885H2251E1]).