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

Novartis

Status and phase: Completed; Phase 2

Conditions: Arthritis, Gouty

Treatments: Other: placebo matching canakinumab; Other: placebo matching dexamethasone; Biological: canakinumab; Drug: dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663169

CACZ885A2212

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6 participants in 2 patient groups

Canakinumab

Experimental group

Description:

Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.

Treatment:

Biological: canakinumab

Other: placebo matching dexamethasone

Dexamethasone

Active Comparator group

Description:

Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.

Treatment:

Other: placebo matching canakinumab

Drug: dexamethasone