Phase 2 N=6 Randomized Double-blind Treatment

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

Arthritis, Gouty

Bottom Line

View on ClinicalTrials.gov: NCT00663169 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Jan 2013

Primary outcome: Primary: Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale — 100; 100 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: canakinumab (Biological); dexamethasone (Drug); placebo matching canakinumab (Other); placebo matching dexamethasone (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Novartis
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale	100; 100	—
SECONDARY Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period	—	—
SECONDARY Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period	—	—
SECONDARY Time to Walk Independently (if Applicable) During Treatment Period	—	—
SECONDARY Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study	0; 0; 0; 0; 0; 1	—
SECONDARY Change in C-reactive Protein (CRP) From Baseline at Month 4	-22.23; -30.30	—
SECONDARY Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4	-579.980; -260.327	—
SECONDARY ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period	0.0; 221.5; 276.5; 92.3; 136.6; 72.37	—
SECONDARY Change From Baseline in Pain Using a Visual Analog Scale at Month 4	-62.0; -65.7	—
SECONDARY Number of Patients Who Took Rescue Medication	0; 0	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00663169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.