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

Arthritis, Gouty Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663169
• Other study ID #: CACZ885A2212
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2008
• Last updated: December 4, 2012
• Start date: April 2008
• Est. completion date: October 2009

Study information

• Verified date: December 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Gouty

Intervention

Biological:
• canakinumab
10 mg/kg intravenous infusion 250 mL over 2 hours.

Drug:
• dexamethasone
12 mg intravenous infusion 50 mL over 30 minutes.

Other:
• placebo matching canakinumab
5% glucose in water intravenous infusion.
• placebo matching dexamethasone
Placebo intravenous infusion.

Locations

Country	Name	City	State
Switzerland	Novartis Investigator Site	Lausanne
United Kingdom	Novartis Investigator Site	Glasgow
United States	Novartis Investigator Site	Birmingham	Alabama
United States	Novartis Investigator Site	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale	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	No
Secondary	Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period		72 hours	No
Secondary	Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period	Time to recurrence is defined as from the point of improvement (good to excellent on Likert scale) to recurrence.	4 months	No
Secondary	Time to Walk Independently (if Applicable) During Treatment Period		4 months	No
Secondary	Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study	Additional safety information can be found in the Adverse Event section.	4 months	Yes
Secondary	Change in C-reactive Protein (CRP) From Baseline at 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	No
Secondary	Change in Serum Amyloid A Protein (SAA) From Baseline at 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	No
Secondary	ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period	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	No
Secondary	Change From Baseline in Pain Using a Visual Analog Scale at 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	No
Secondary	Number of Patients Who Took Rescue Medication	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	No