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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00663169
First received: April 18, 2008
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00663169

Locations
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
Switzerland
Novartis Investigator Site
Lausanne, Switzerland
United Kingdom
Novartis Investigator Site
Glasgow, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis investigator site
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Arthritis Gouty
ACZ885
IL1B protein
Pain

Additional relevant MeSH terms:
Arthritis
Arthritis, Gouty
Genetic Diseases, Inborn
Gout
Joint Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Musculoskeletal Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Rheumatic Diseases
Antibodies, Monoclonal
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014