Clinical Trial: Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/ or Colchi

Brief Summary: The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: The change in the gout pain intensity in the target joint following ACZ885 administration measured by Visual Analog Scale (VAS) The time to first new gout flare [ Time Frame: at 72 hours post-dose, 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evaluate the time to 50% reduction of baseline pain intensity (measured on a 0-100 mm Visual Analog Scale) in the most affected joint affected by gout flare [ Time Frame: 12 weeks ]
  • Evaluate the percentage of patients with at least 1 new gout flare [ Time Frame: 12 weeks ]
  • Evaluate the efficacy of canakinumab compared with respect to the treatment of signs and symptoms of each acute gout flare [ Time Frame: 12 weeks ]
  • To evaluate the rescue medication use [ Time Frame: 12 weeks ]
  • To evaluate the efficacy of canakinumab with regards to inflammatory markers (high sensitivity C-reactive protein [hsCRP]) measured in the serum [ Time Frame: 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: May 24, 2011
Date Started: September 2002
Date Completion:
Last Updated: October 13, 2015
Last Verified: October 2015