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. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01362608
First received: May 24, 2011
Last updated: June 24, 2014
Last verified: June 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
Drug: 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 Study Completion Date: July 2015
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 Drug: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Argentina
Novartis Investigative Site Completed
Caba, Buenos Aires, Argentina, C1013AAR
Novartis Investigative Site Not yet recruiting
Caba, Buenos Aires, Argentina, C1400
Novartis Investigative Site Withdrawn
Cordoba, Argentina, X5022CPU
Novartis Investigative Site Withdrawn
San Juan, Argentina, J5402DIL
Novartis Investigative Site Withdrawn
Tucuman, Argentina, T4000AXL
China, Anhui
Novartis Investigative Site Recruiting
Hefei, Anhui, China, 230001
Novartis Investigative Site Recruiting
Hefei, Anhui, China, 230022
China, Beijing
Novartis Investigative Site Recruiting
Beijing, Beijing, China, 100730
China, Guangdong
Novartis Investigative Site Recruiting
Guangzhou, Guangdong, China, 510030
China, Jiangsu
Novartis Investigative Site Recruiting
Nanjing, Jiangsu, China, 210029
China, Shanxi
Novartis Investigative Site Recruiting
Xi'an, Shanxi, China, 710032
China, Sichuan
Novartis Investigative Site Not yet recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
Novartis Investigative Site Recruiting
Hangzhou, Zhejiang, China, 310009
China
Novartis Investigative Site Recruiting
Beijing, China, 100029
Novartis Investigative Site Recruiting
Beijing, China, 100044
Novartis Investigative Site Recruiting
Chengdu, China, 610072
Novartis Investigative Site Not yet recruiting
Shanghai, China, 200032
Novartis Investigative Site Recruiting
Shanghai, China, 200433
Novartis Investigative Site Recruiting
Shanghai, China, 200127
Poland
Novartis Investigative Site Recruiting
Katowice, Poland, 40-084
Novartis Investigative Site Completed
Katowice, Poland, 40-635
Novartis Investigative Site Withdrawn
Krakow, Poland, 31-159
Novartis Investigative Site Completed
Kutno, Poland, 99-300
Novartis Investigative Site Recruiting
Poznan, Poland, 60-773
Novartis Investigative Site Completed
Wroclaw, Poland, 50-044
Novartis Investigative Site Recruiting
Wroclaw, Poland, 50-349
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 119074
Novartis Investigative Site Recruiting
Singapore, Singapore, 529889
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01362608     History of Changes
Other Study ID Numbers: CACZ885H2358, 2010-024172-26
Study First Received: May 24, 2011
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration
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

Keywords provided by Novartis:
Gout
Inflammatory gout
acute gout

Additional relevant MeSH terms:
Gout
Arthritis, Gouty
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Antibodies, Monoclonal
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014