Clinical Trial: Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
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
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 Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing [ Time Frame: 12 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The time to the first new gout flare [ Time Frame: 12 Weeks ]
- Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution [ Time Frame: 12 weeks ]
- Number of patients needing rescue medication use during acute gouty arthritis flare(s) [ Time Frame: 12 Weeks ]
- Measurement of efficacy using inflammatory markers [ Time Frame: 12 Weeks ]
- Time to 50% reduction of baseline pain intensity in the most affected joint [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: May 3, 2012
Date Started: September 2012
Date Completion: September 2012
Last Updated: April 19, 2017
Last Verified: August 2013
