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

This study is currently recruiting participants.
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01362608
First received: May 24, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Gouty Arthritis
Biological: Canakinumab, ACZ885
Drug: Triamcinolone acetonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Colchicine Are Contraindicated, Not Tolerated or Ineffective

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the percentage of patients with at least 1 new gout flare [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Evaluate the efficacy of canakinumab compared with respect to the treatment of signs and symptoms of each acute gout flare [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To evaluate the rescue medication use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 274
Study Start Date: July 2011
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canakinumab and placebo matching to triamcinolone acetonide Biological: Canakinumab, ACZ885
Canakinumab and placebo matching to triamcinolone acetonide
Active Comparator: Triamcinolone acetonide 40 mg Drug: Triamcinolone acetonide
Triamcinolone acetonide 40 mg and placebo matching to canakinumab

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Meeting diagnosis criteria for acute arthritis of primary gout.
  • Start of acute gout flare within 5 days prior to study visit 1
  • History of ≥ 3 gout flares within the 12 months prior to study start
  • Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines

Exclusion criteria:

  • Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide
  • Refractory heart failure (Stage D).
  • Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
  • Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout
  • Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362608

Contacts
Contact: Novartis Pharmaceuticals 41-61-324-1111

Locations
Argentina
Novartis Investigative Site Recruiting
Buenos Aires, Argentina
Contact: Novartis Pharmaceuticals    41613241111      
China
Novartis Investigative site Recruiting
Shanghai, China
Contact: Novartis Pharmaceuticals    41-61-324-1111      
Poland
Novartis Investigative site Recruiting
Wroclaw, Poland
Contact: Novartis Pharmaceuticals    41613241111      
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore
Contact: Novartis Pharmaceuticals    41613241111      
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01362608     History of Changes
Other Study ID Numbers: CACZ885H2358, 2010-024172-26
Study First Received: May 24, 2011
Last Updated: March 6, 2014
Health Authority: Argentina: Ministry of Health
China: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Health Sciences Authority
United States: Food and Drug Administration

Keywords provided by Novartis:
Gout
Inflammatory gout
acute gout

Additional relevant MeSH terms:
Arthritis
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Gout
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Triamcinolone
Triamcinolone Acetonide
Colchicine
Antibodies, Monoclonal
Triamcinolone diacetate
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Antirheumatic Agents
Antineoplastic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014