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

Acute Gouty Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01593527
• Other study ID #: CACZ885H2402
• Secondary ID: 2011-001766-18
• Status: Withdrawn
• Phase: Phase 3
• First received: May 3, 2012
• Last updated: April 19, 2017
• Start date: September 2012
• Est. completion date: September 2012

Study information

• Verified date: August 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Gouty Arthritis
• Arthritis
• Arthritis, Gouty
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• ACZ885
Canakinumab 150 mg s.c.
• Triamcinelone acetonide
Triamcinelone acetonide 40 mg i.m.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing		12 Weeks
Secondary	The time to the first new gout flare		12 Weeks
Secondary	Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution		12 weeks
Secondary	Number of patients needing rescue medication use during acute gouty arthritis flare(s)		12 Weeks
Secondary	Measurement of efficacy using inflammatory markers		12 Weeks
Secondary	Time to 50% reduction of baseline pain intensity in the most affected joint		12 weeks