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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion criteria:

• 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

Exclusion criteria:

• 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