CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 397 enrolled
Drug / intervention
Canakinumab pre-filled syringe +3 moredrug
Likely dose
Not stated in 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/NCT01356602
NCT01356602Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients

Novartis Pharmaceuticals·interventional·Posted May 19, 2011·Updated Jan 29, 2014

In Brief

A Phase 3 clinical trial evaluating Canakinumab pre-filled syringe, Canakinumab lyophilized powder, and 2 other interventions for Acute Gouty Arthritis. Completed, enrolled 397 participants across 99 sites in 5 countries.

Detailed Summary

This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Gouty Arthritis
CountriesCanada, Germany, Hungary, Lithuania, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 19, 2011
Enrollment StartMay 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.1 years ago

Interventions

Canakinumab pre-filled syringedrug

Canakinumab pre-filled syringe

Canakinumab lyophilized powderdrug

Canakinumab lyophilized powder

Triamcinolone Acetonidedrug

Triamcinolone Acetonide

Placebodrug

Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide