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

• Status: Terminated
• Trial end date: 2015-05-19
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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