Back to resultsLong-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Primary Purpose
Acute Gouty Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Canakinumab 150mg in prefilled syringe
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gouty Arthritis focused on measuring Gout, arthritis, gout flare, acute gout, gouty, rheumatic disease, uric acid, podagra
Eligibility Criteria
Inclusion criteria:
- Compliance and completion of the canakinumab PFS core study
- Unchanged significant clinical medical history from entry into core study
Exclusion criteria:
- Physician judgment of unsuitability for the study
- Pregnant or nursing women 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
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Canakinumab 150mg
Arm Description
Canakinumab 150mg in prefilled syringe subcutaneously
Outcomes
Primary Outcome Measures
Number of Participants Who Reported Adverse Events
Secondary Outcome Measures
Probability of New Gout Flares at End of Study
The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates.
Number of Participant With New Flares
The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered.
Change From Baseline in Pain Intensity on a 5-point Likert Scale
A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days.
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment
Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor).
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Tenderness was measured on a 0-3 point scale: no pain, participant states that "there is pain", participant states "there is pain and winces" and participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable.
Number of Participants Responded for Physician's Global Assessment of Response to Treatment
The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor.
Full Information
NCT ID
NCT01431638
First Posted
August 30, 2011
Last Updated
June 28, 2021
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01431638
Brief Title
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Official Title
A 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 25, 2011 (Actual)
Primary Completion Date
May 9, 2013 (Actual)
Study Completion Date
May 9, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gouty Arthritis
Keywords
Gout, arthritis, gout flare, acute gout, gouty, rheumatic disease, uric acid, podagra
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Uncontrolled
Masking
None (Open Label)
Allocation
N/A
Enrollment
397 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canakinumab 150mg
Arm Type
Experimental
Arm Description
Canakinumab 150mg in prefilled syringe subcutaneously
Intervention Type
Drug
Intervention Name(s)
Canakinumab 150mg in prefilled syringe
Intervention Description
Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares
Primary Outcome Measure Information:
Title
Number of Participants Who Reported Adverse Events
Time Frame
From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Secondary Outcome Measure Information:
Title
Probability of New Gout Flares at End of Study
Description
The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates.
Time Frame
Up to Day 337
Title
Number of Participant With New Flares
Description
The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered.
Time Frame
up to 36 weeks
Title
Change From Baseline in Pain Intensity on a 5-point Likert Scale
Description
A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days.
Time Frame
Baseline, upto 14 days post-dose
Title
Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time
Description
Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.
Time Frame
Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose
Title
Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment
Description
Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor).
Time Frame
48 weeks post-dose
Title
Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint
Description
Tenderness was measured on a 0-3 point scale: no pain, participant states that "there is pain", participant states "there is pain and winces" and participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable.
Time Frame
Baseline, 7 days post-dose
Title
Number of Participants Responded for Physician's Global Assessment of Response to Treatment
Description
The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor.
Time Frame
7 days post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Compliance and completion of the canakinumab PFS core study
Unchanged significant clinical medical history from entry into core study
Exclusion criteria:
Physician judgment of unsuitability for the study
Pregnant or nursing women 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
Anniston
State/Province
Alabama
ZIP/Postal Code
36207-5710
Country
United States
Facility Name
Novartis Investigative Site
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36547
Country
United States
Facility Name
Novartis Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Novartis Investigative Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Novartis Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Novartis Investigative Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Novartis Investigative Site
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Novartis Investigative Site
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Novartis Investigative Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Novartis Investigative Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Novartis Investigative Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Novartis Investigative Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
Novartis Investigative Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30035
Country
United States
Facility Name
Novartis Investigative Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novartis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Novartis Investigative Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Novartis Investigative Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Novartis Investigative Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Novartis Investigative Site
City
Belzoni
State/Province
Mississippi
ZIP/Postal Code
39038
Country
United States
Facility Name
Novartis Investigative Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39209
Country
United States
Facility Name
Novartis Investigative Site
City
Picayune
State/Province
Mississippi
ZIP/Postal Code
39466
Country
United States
Facility Name
Novartis Investigative Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Novartis Investigative Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Novartis Investigative Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Novartis Investigative Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Novartis Investigative Site
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Novartis Investigative Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Novartis Investigative Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Novartis Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Novartis Investigative Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Novartis Investigative Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Novartis Investigative Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28152
Country
United States
Facility Name
Novartis Investigative Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Novartis Investigative Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Novartis Investigative Site
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Novartis Investigative Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Novartis Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Novartis Investigative Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Novartis Investigative Site
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
Novartis Investigative Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Novartis Investigative Site
City
Varnville
State/Province
South Carolina
ZIP/Postal Code
29944
Country
United States
Facility Name
Novartis Investigative Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Novartis Investigative Site
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Novartis Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38125
Country
United States
Facility Name
Novartis Investigative Site
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novartis Investigative Site
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Novartis Investigative Site
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Novartis Investigative Site
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Novartis Investigative Site
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Novartis Investigative Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Novartis Investigative Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Novartis Investigative Site
City
St-John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1E 2C2
Country
Canada
Facility Name
Novartis Investigative Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
Facility Name
Novartis Investigative Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Novartis Investigative Site
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novartis Investigative Site
City
Loehne
ZIP/Postal Code
32584
Country
Germany
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39110
Country
Germany
Facility Name
Novartis Investigative Site
City
Weener
ZIP/Postal Code
26826
Country
Germany
Facility Name
Novartis Investigative Site
City
Kaunas
State/Province
LT
ZIP/Postal Code
51349
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Kaunas
State/Province
LT
ZIP/Postal Code
LT-50128
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Vilnius
State/Province
LT
ZIP/Postal Code
01117
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Vilnius
ZIP/Postal Code
09310
Country
Lithuania
Facility Name
Novartis Investigative Site
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Learn more about this trial
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
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