Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Novartis

Status and phase: Completed; Phase 3

Conditions: Acute Gouty Arthritis

Treatments: Drug: Canakinumab 150mg in prefilled syringe

Study type: Interventional

Funder types: Industry

Identifiers

NCT01431638

CACZ885H2361E1

2011-001342-15

Details and patient eligibility

About

This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Enrollment: 397 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Compliance and completion of the canakinumab PFS core study
• Unchanged significant clinical medical history from entry into core study

Exclusion criteria

• Physician judgment of unsuitability for the study
• Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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397 participants in 1 patient group

Canakinumab 150mg

Experimental group

Description:

Canakinumab 150mg in prefilled syringe subcutaneously

Treatment:

Drug: Canakinumab 150mg in prefilled syringe