Back to resultsLong Term Study of Canakinumab (ACZ885) in Patients With Gout
Primary Purpose
Gouty Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Canakinumab
Sponsored by
About this trial
This is an interventional treatment trial for Gouty Arthritis focused on measuring Gouty, Gouty arthritis, Gout flares, Anti-interleukin-1β monoclonal antibody
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
Sites / Locations
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
- Novartis Investigative site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
canakinumab
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00927810
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 5, 2009 (Actual)
Primary Completion Date
August 4, 2010 (Actual)
Study Completion Date
August 4, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gouty Arthritis
Keywords
Gouty, Gouty arthritis, Gout flares, Anti-interleukin-1β monoclonal antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
341 (Actual)
8. Arms, Groups, and Interventions
Arm Title
canakinumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Canakinumab
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events and Serious Adverse Events
Description
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
Time Frame
From start of study up to study completion (up to 14 months)
Secondary Outcome Measure Information:
Title
Difference Change From Baseline in Participant's Gout Pain During First Flare
Description
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.
Time Frame
Baseline and Day 7
Title
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Description
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.
Time Frame
24 weeks
Title
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Description
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.
Time Frame
24 weeks
Title
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
Description
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.
Time Frame
24 weeks
Title
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group
Description
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Novartis Investigative site
City
Capital Federal Buenos Aires
ZIP/Postal Code
1027
Country
Argentina
Facility Name
Novartis Investigative site
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Novartis Investigative site
City
Barranquilla
Country
Colombia
Facility Name
Novartis Investigative site
City
Bogotá
Country
Colombia
Facility Name
Novartis Investigative site
City
Bucaramanga
Country
Colombia
Facility Name
Novartis Investigative site
City
Floridablanca
Country
Colombia
Facility Name
Novartis Investigative site
City
Praha 5
State/Province
Czech Republic
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Novartis Investigative site
City
Sachsen
State/Province
Dresden / Schützenhöhe 16
ZIP/Postal Code
D-01099
Country
Germany
Facility Name
Novartis Investigative site
City
Bayern
State/Province
München / Mühlbaurstraße 16
ZIP/Postal Code
D-81677
Country
Germany
Facility Name
Novartis Investigative site
City
Dessau
State/Province
Roßlau / Kühnauer Straße 70 Sachsen- Anhalt
ZIP/Postal Code
D-06846
Country
Germany
Facility Name
Novartis Investigative site
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Novartis Investigative site
City
Debrecen
State/Province
Bartók B U 2-26
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Novartis Investigative site
City
Kistarcsa
State/Province
Semmelweis Tér 1.
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Novartis Investigative site
City
Eger
State/Province
Széchenyi U 27-29
ZIP/Postal Code
3301
Country
Hungary
Facility Name
Novartis Investigative site
City
Zalaegerszeg
State/Province
Zrínyi U 1
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Novartis Investigative site
City
Poznań
ZIP/Postal Code
NA 61- 734
Country
Poland
Facility Name
Novartis Investigative site
City
Wrocław
ZIP/Postal Code
NA 50-333
Country
Poland
Facility Name
Novartis Investigative site
City
Lisboa
ZIP/Postal Code
1749-004
Country
Portugal
Facility Name
Novartis Investigative site
City
Chelyabinsk
ZIP/Postal Code
454047
Country
Russian Federation
Facility Name
Novartis Investigative site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Novartis Investigative site
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Novartis Investigative site
City
Petrozavodsk
Country
Russian Federation
Facility Name
Novartis Investigative site
City
Saint Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Novartis Investigative site
City
Saint Petersburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
Novartis Investigative site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Novartis Investigative site
City
Singapore
ZIP/Postal Code
169611
Country
Singapore
Facility Name
Novartis Investigative site
City
Bratislava
ZIP/Postal Code
N/A 813 69
Country
Slovakia
Facility Name
Novartis Investigative site
City
Košice
ZIP/Postal Code
N/A 042 66
Country
Slovakia
Facility Name
Novartis Investigative site
City
Nitra
ZIP/Postal Code
N/A 949 01
Country
Slovakia
Facility Name
Novartis Investigative site
City
Piešťany
ZIP/Postal Code
N/A 921 12
Country
Slovakia
Facility Name
Novartis Investigative site
City
Trenčín
ZIP/Postal Code
N/A 911 50
Country
Slovakia
Facility Name
Novartis Investigative site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0153
Country
South Africa
Facility Name
Novartis Investigative site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novartis Investigative site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Novartis Investigative site
City
Kaohsiung
ZIP/Postal Code
81346
Country
Taiwan
Facility Name
Novartis Investigative site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Novartis Investigative site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Novartis Investigative site
City
Ankara
State/Province
Bahcellievler
ZIP/Postal Code
06490
Country
Turkey
Facility Name
Novartis Investigative site
City
Adana
State/Province
Balcali
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Novartis Investigative site
City
İzmir
State/Province
Inciraltı
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Novartis Investigative site
City
Aydın
State/Province
Merkez
ZIP/Postal Code
09100
Country
Turkey
Facility Name
Novartis Investigative site
City
Manisa
State/Province
Merkez
ZIP/Postal Code
45010
Country
Turkey
Facility Name
Novartis Investigative site
City
Gaziantep
State/Province
Sehitkamil
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Novartis Investigative site
City
Jarrow
State/Province
Tyne & Wear
ZIP/Postal Code
NE32 3DT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21540198
Citation
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.
Results Reference
result
Learn more about this trial
Long Term Study of Canakinumab (ACZ885) in Patients With Gout
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