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Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

NCT01431638 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2021-07-19

Study results available
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Summary

This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Conditions

  • Acute Gouty Arthritis

Interventions

DRUG

Canakinumab 150mg in prefilled syringe

Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-08-25
Primary Completion
2013-05-09
Completion
2013-05-09

Countries

  • United States
  • Canada
  • Germany
  • Lithuania

Study Locations

More Related Trials

Entities

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 NCT01431638 on ClinicalTrials.gov