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Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: April 18, 2008
Last updated: December 4, 2012
Last verified: December 2012
This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.

Condition Intervention Phase
Arthritis, Gouty
Biological: canakinumab
Drug: dexamethasone
Other: placebo matching canakinumab
Other: placebo matching dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale [ Time Frame: 72 hours ]
    72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.

Secondary Outcome Measures:
  • Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period [ Time Frame: 72 hours ]
  • Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period [ Time Frame: 4 months ]
    Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.

  • Time to Walk Independently (if Applicable) During Treatment Period [ Time Frame: 4 months ]
  • Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study [ Time Frame: 4 months ]
    Additional safety information can be found in the Adverse Event section.

  • Change in C-reactive Protein (CRP) From Baseline at Month 4 [ Time Frame: Baseline, Month 4 ]
    Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.

  • Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4 [ Time Frame: Baseline, Month 4 ]
    Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.

  • ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period [ Time Frame: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119 ]
    Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA).

  • Change From Baseline in Pain Using a Visual Analog Scale at Month 4 [ Time Frame: Baseline, Month 4 ]
    Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement.

  • Number of Patients Who Took Rescue Medication [ Time Frame: 4 months ]
    Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator.

Enrollment: 6
Study Start Date: April 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canakinumab
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
Biological: canakinumab
10 mg/kg intravenous infusion 250 mL over 2 hours.
Other Names:
  • ACZ885
  • Ilaris®
Other: placebo matching dexamethasone
Placebo intravenous infusion.
Active Comparator: Dexamethasone
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
Drug: dexamethasone
12 mg intravenous infusion 50 mL over 30 minutes.
Other: placebo matching canakinumab
5% glucose in water intravenous infusion.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • score over 50 on the 0-100 VAS pain scale
  • acute, confirmed gout flare for no longer than 3 days

Exclusion Criteria:

  • Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
  • Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
  • Pregnant or breastfeeding women
  • Major surgery with high infection risk
  • History of severe allergy to food or drugs
  • History or risk of tuberculosis
  • Active infection

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 identifier: NCT00663169

United States, Alabama
Novartis Investigator Site
Birmingham, Alabama, United States, 35249
United States, New Jersey
Novartis Investigator Site
New Brunswick, New Jersey, United States, 08901
Novartis Investigator Site
Lausanne, Switzerland
United Kingdom
Novartis Investigator Site
Glasgow, United Kingdom
Sponsors and Collaborators
Principal Investigator: Novartis Novartis investigator site
  More Information

Responsible Party: Novartis Identifier: NCT00663169     History of Changes
Other Study ID Numbers: CACZ885A2212
Study First Received: April 18, 2008
Results First Received: August 30, 2012
Last Updated: December 4, 2012

Keywords provided by Novartis:
Arthritis Gouty
IL1B protein

Additional relevant MeSH terms:
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antibodies, Monoclonal
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors processed this record on April 28, 2017