WithdrawnPhase 3

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

0Started 2012-09

Plain-language 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).

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 12 Weeks

Trial details

NCT IDNCT01593527

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-09

View on ClinicalTrials.gov More Acute Gouty Arthritis trials