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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

NCT01362608 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2017-06-08

Study results available
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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.

Conditions

  • Gouty Arthritis

Interventions

DRUG

Canakinumab, ACZ885

Canakinumab and placebo matching to triamcinolone acetonide

DRUG

Triamcinolone acetonide

Triamcinolone acetonide 40 mg and placebo matching to canakinumab

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-20
Primary Completion
2015-05-19
Completion
2015-05-19

Countries

  • Argentina
  • China
  • Poland
  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01362608 on ClinicalTrials.gov