Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

Novartis

Status and phase: Terminated; Phase 3

Conditions: Gouty Arthritis

Treatments: Drug: Canakinumab, ACZ885; Drug: Triamcinolone acetonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01362608

CACZ885H2358

2010-024172-26

Details and patient eligibility

About

The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.

Enrollment: 136 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meeting diagnosis criteria for acute arthritis of primary gout.
• Start of acute gout flare within 5 days prior to study visit 1
• History of ≥ 3 gout flares within the 12 months prior to study start
• Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines

Exclusion criteria

• Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide
• Refractory heart failure (Stage D).
• Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
• Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout
• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups

Canakinumab and placebo matching to triamcinolone acetonide

Experimental group

Description:

ACZ885H

Treatment:

Drug: Canakinumab, ACZ885

Triamcinolone acetonide 40 mg

Active Comparator group

Description:

ACZ885H

Treatment:

Drug: Triamcinolone acetonide