Back to resultsCanakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
Primary Purpose
Acute Gouty Arthritis
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ACZ885
Triamcinelone acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gouty Arthritis focused on measuring Frequent flares, Frequent attacks, gout, gouty arthritis, Chronic kidney disease, renal impairment, Anti-interleukin-1β monoclonal antibody, anti-inflammatory therapy
Eligibility Criteria
Inclusion criteria:
- Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
- Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
- Onset of current acute gouty arthritis flare within 3 days prior to randomization
Exclusion criteria:
- Hemodialysis CKD Stage 5 Organ transplantation
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
- Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Canakinumab 150 mg s.c.
Triamcinelone acetonide 40 mg i.m.
Outcomes
Primary Outcome Measures
Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing
Secondary Outcome Measures
The time to the first new gout flare
Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution
Number of patients needing rescue medication use during acute gouty arthritis flare(s)
Measurement of efficacy using inflammatory markers
Time to 50% reduction of baseline pain intensity in the most affected joint
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01593527
Brief Title
Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
Official Title
A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Withdrawn
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gouty Arthritis
Keywords
Frequent flares, Frequent attacks, gout, gouty arthritis, Chronic kidney disease, renal impairment, Anti-interleukin-1β monoclonal antibody, anti-inflammatory therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Canakinumab 150 mg s.c.
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Triamcinelone acetonide 40 mg i.m.
Intervention Type
Drug
Intervention Name(s)
ACZ885
Intervention Description
Canakinumab 150 mg s.c.
Intervention Type
Drug
Intervention Name(s)
Triamcinelone acetonide
Intervention Description
Triamcinelone acetonide 40 mg i.m.
Primary Outcome Measure Information:
Title
Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
The time to the first new gout flare
Time Frame
12 Weeks
Title
Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution
Time Frame
12 weeks
Title
Number of patients needing rescue medication use during acute gouty arthritis flare(s)
Time Frame
12 Weeks
Title
Measurement of efficacy using inflammatory markers
Time Frame
12 Weeks
Title
Time to 50% reduction of baseline pain intensity in the most affected joint
Time Frame
12 weeks
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:
Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
Onset of current acute gouty arthritis flare within 3 days prior to randomization
Exclusion criteria:
Hemodialysis CKD Stage 5 Organ transplantation
Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply
12. IPD Sharing Statement
Learn more about this trial
Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
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