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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01362608
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab, ACZ885 — DRUG
    Canakinumab and placebo matching to triamcinolone acetonide
  • Triamcinolone acetonide — DRUG
    Triamcinolone acetonide 40 mg and placebo matching to canakinumab

Study Details

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.

Key Dates

Start date
Jun 20, 2011
Status verified
Jun 2017
Primary completion
May 19, 2015
Completion
May 19, 2015

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab and placebo matching to triamcinolone acetonide
    ACZ885H
  • Active Comparator: Triamcinolone acetonide 40 mg
    ACZ885H

Primary Outcome Measure

The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS) [ Time Frame: at 72 hours post-dose ]

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