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

Novartis Pharmaceuticals

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Acute Gouty Arthritis

Interventions

ACZ885DRUG

Canakinumab 150 mg s.c.

Triamcinelone acetonideDRUG

Triamcinelone acetonide 40 mg i.m.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing

Time frame: 12 Weeks

Secondary Outcomes

The time to the first new gout flare

Time frame: 12 Weeks

Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution

Time frame: 12 weeks

Number of patients needing rescue medication use during acute gouty arthritis flare(s)

Time frame: 12 Weeks

Measurement of efficacy using inflammatory markers

Time frame: 12 Weeks

Time to 50% reduction of baseline pain intensity in the most affected joint

Time frame: 12 weeks

Data from ClinicalTrials.gov

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