Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Gouty Arthritis

In brief

This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

Key facts

Study ID

NCT01356602

Run by

Novartis Pharmaceuticals

People needed

397

Starts

2011-05-01

Expected to finish

2012-09-01

Last updated by the study team

2014-01-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 3 or more gout flares within last year
• Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
• Body mass index of less than or equal to 45 kg/m2

You may not qualify if…

• Use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine.
• Hemodialysis
• Live vaccine within 3 months before first dose
• Donation or loss of 400 mL or more within 3 months before first dose
• Gout brought on by other factors such as chemotherapy, lead, transplant, etc.
• Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis
• Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions
• Significant cardiovascular conditions such as uncontrolled hypertension
• Significant medical diseases such as uncontrolled diabetes, thyroid disease
• History of malignancy of any organ system within the past 5 years
• Women who are pregnant or nursing
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Gulf Shores, Alabama, United States
• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Chandler, Arizona, United States
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Scottsdale, Arizona, United States
• Novartis Investigative Site — Buena Park, California, United States
• Novartis Investigative Site — Fair Oaks, California, United States
• Novartis Investigative Site — Norwalk, California, United States
• Novartis Investigative Site — Orangevale, California, United States
• Novartis Investigative Site — Pasadena, California, United States
• Novartis Investigative Site — Westlake Village, California, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigative Site — Jupiter, Florida, United States
• Novartis Investigative Site — Largo, Florida, United States
• Novartis Investigative Site — South Miami, Florida, United States
• Novartis Investigative Site — Augusta, Georgia, United States
• Novartis Investigative Site — Decatur, Georgia, United States
• Novartis Investigative Site — Meridian, Idaho, United States
• Novartis Investigative Site — Overland Park, Kansas, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Owensboro, Kentucky, United States
• Novartis Investigative Site — Metairie, Louisiana, United States
• Novartis Investigative Site — Troy, Michigan, United States
• Novartis Investigative Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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