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

December 4, 2012 updated by: Novartis

A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland
        • Novartis Investigator Site
  • United Kingdom
      • Glasgow, United Kingdom
        • Novartis Investigator Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Novartis Investigator Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Novartis Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period
Time Frame: 72 hours
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.
4 months
Time to Walk Independently (if Applicable) During Treatment Period
Time Frame: 4 months
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.
4 months
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.
Baseline, Month 4
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.
Baseline, Month 4
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).
Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119
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.
Baseline, Month 4
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

January 7, 2013

Last Update Submitted That Met QC Criteria

December 4, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CACZ885A2212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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