Phase 2
Completed N=6
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
Arthritis, Gouty
Source: ClinicalTrials.gov NCT00663169 ↗
Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Jan 2013
Primary outcomePrimary: Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale — 100; 100 Percentage of participants
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.
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 | — |
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
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. Informational only — not medical advice.