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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01431638
• Date of registration: 30/08/2011
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
• Scientific title: A 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients
• Date of first enrolment: August 2011
• Target sample size: 233
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01431638
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, Germany, Lithuania, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Gouty Arthritis

Intervention(s)

Drug: Canakinumab 150mg in prefilled syringe

Primary Outcome(s)

Safety and tolerability of repeated dosing of canakinumab 150mg s.c. PFS [Time Frame: 36 weeks]

Secondary Outcome(s)

Immunogenicity of repeated dosing of canakinumab 150mg s.c. PFS [Time Frame: 36 weeks]

The time to the first new gouty arthritis flare since the entry into the core study [Time Frame: 36 weeks]

Frequency of new gouty arthritis flares [Time Frame: 36 Weeks]

Pharmacokinetics (PK) of canakinumab 150mg s.c. PFS [Time Frame: 36 Weeks]

Signs and symptoms of new gouty arthritis flares [Time Frame: 36 Weeks]

Secondary ID(s)

CACZ885H2361E1

2011-001342-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors