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

Conditions

• Arthritis, Gouty

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• canakinumab — BIOLOGICAL
  10 mg/kg intravenous infusion 250 mL over 2 hours.
• dexamethasone — DRUG
  12 mg intravenous infusion 50 mL over 30 minutes.
• placebo matching canakinumab — OTHER
  5% glucose in water intravenous infusion.
• placebo matching dexamethasone — OTHER
  Placebo intravenous infusion.

Study Details

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.

Key Dates

Start date

Apr 30, 2008

Status verified

Dec 2012

Primary completion

Oct 31, 2009

Completion

Oct 31, 2009

Study Design

Enrollment

6 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Canakinumab
  Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
• Active Comparator: Dexamethasone
  Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.

Primary Outcome Measure

Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale [ Time Frame: 72 hours ]

Locations (2)

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