Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
Phase 3
Withdrawn
- Conditions
- Acute Gouty Arthritis
- Interventions
- Drug: Triamcinelone acetonide
- Registration Number
- NCT01593527
- Lead Sponsor
- Novartis Pharmaceuticals
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 ACZ885 Canakinumab 150 mg s.c. Arm 2 Triamcinelone acetonide Triamcinelone acetonide 40 mg i.m.
- Primary Outcome Measures
Name Time Method Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing 12 Weeks
- Secondary Outcome Measures
Name Time Method Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution 12 weeks Number of patients needing rescue medication use during acute gouty arthritis flare(s) 12 Weeks Measurement of efficacy using inflammatory markers 12 Weeks Time to 50% reduction of baseline pain intensity in the most affected joint 12 weeks The time to the first new gout flare 12 Weeks