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

Novartis

Status and phase: Withdrawn; Phase 3

Conditions: Acute Gouty Arthritis

Treatments: Drug: ACZ885; Drug: Triamcinelone acetonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01593527

CACZ885H2402

2011-001766-18 (EudraCT Number)

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Arm 1

Experimental group

Description:

Canakinumab 150 mg s.c.

Treatment:

Drug: ACZ885

Arm 2

Experimental group

Description:

Triamcinelone acetonide 40 mg i.m.

Treatment:

Drug: Triamcinelone acetonide