Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease

April 19, 2017 updated by: Novartis Pharmaceuticals

A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease

The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
  • Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
  • Onset of current acute gouty arthritis flare within 3 days prior to randomization

Exclusion criteria:

  • Hemodialysis CKD Stage 5 Organ transplantation
  • Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
  • Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Canakinumab 150 mg s.c.
Drug: ACZ885
Canakinumab 150 mg s.c.
Experimental: Arm 2
Triamcinelone acetonide 40 mg i.m.
Drug: Triamcinelone acetonide
Triamcinelone acetonide 40 mg i.m.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The time to the first new gout flare
Time Frame: 12 Weeks
12 Weeks
Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution
Time Frame: 12 weeks
12 weeks
Number of patients needing rescue medication use during acute gouty arthritis flare(s)
Time Frame: 12 Weeks
12 Weeks
Measurement of efficacy using inflammatory markers
Time Frame: 12 Weeks
12 Weeks
Time to 50% reduction of baseline pain intensity in the most affected joint
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 4, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CACZ885H2402
  • 2011-001766-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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