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Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

NCT01356602 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2014-01-29

Study results available
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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.

Conditions

  • Acute Gouty Arthritis

Interventions

DRUG

Canakinumab pre-filled syringe

Canakinumab pre-filled syringe

DRUG

Canakinumab lyophilized powder

Canakinumab lyophilized powder

DRUG

Triamcinolone Acetonide

Triamcinolone Acetonide

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States
  • Canada
  • Germany
  • Hungary
  • Lithuania

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01356602 on ClinicalTrials.gov