β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)

Novartis

Status and phase: Completed; Phase 3

Conditions: Acute Gouty Arthritis Flares

Treatments: Drug: ACZ885; Drug: Triamcinolone acetonide 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01470989

2011-003414-17

CACZ885H2357E3

Details and patient eligibility

About

This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have completed the second extension studies CACZ885H2356E2 or CACZ885H2357E2
• Patients treated with canakinumab in the core studies or subsequent extensions

Exclusion criteria

• Pregnant or nursing (lactating) women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 1 patient group

canakinumab

Experimental group

Description:

canakinumab 150 mg s.c.

Treatment:

Drug: Triamcinolone acetonide 40 mg

Drug: ACZ885