CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
canakinumab +3 morebiological
Likely dose
canakinumab 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00663169
NCT00663169Phase 2Completed

A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout

Novartis·interventional·Posted Apr 22, 2008·Updated Jan 7, 2013

In Brief

A Phase 2 clinical trial evaluating canakinumab, dexamethasone, and 2 other interventions for Arthritis, Gouty. Completed, enrolled 6 participants across 4 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSwitzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 22, 2008
Enrollment StartApr 1, 2008
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.2 years ago

Interventions

canakinumabbiological

10 mg/kg intravenous infusion 250 mL over 2 hours.

dexamethasonedrug

12 mg intravenous infusion 50 mL over 30 minutes.

placebo matching canakinumabother

5% glucose in water intravenous infusion.

placebo matching dexamethasoneother

Placebo intravenous infusion.