Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
Condition: Acute Gout
MeSH terms: Gout
Intervention: Canakinumab; Canakinumab; Canakinumab; Canakinumab; Canakinumab; Triamcinolone acetonide
Intervention description: Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.; Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.; Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.; Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.; Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.; Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Antibodies, Monoclonal; Triamcinolone diacetate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Acute flares; Gout; Anti-interleukin-1β monoclonal antibody; Colchicine; Triamcinolone acetonide

Summary:

      This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the
      management of acute flare in gout patients who are contraindicated to Non-Steroidal
      anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the
      corticosteroid triamcinolone acetonide.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of at least 1 gout flare prior to the Screening Visit

          -  Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the
             classification of acute arthritis of primary gout.

          -  Presence of acute gout flare for no longer than 5 days.

          -  Baseline pain intensity > or = to 50 mm on the 0-100 mm VAS.

          -  Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both.

        Exclusion Criteria:

          -  Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other
             acute inflammatory arthritis.

          -  Presence of severe renal function impairment

          -  Contraindication to intramuscular injection

          -  Known presence or suspicion of active or recurrent bacterial, fungal or viral
             infection at the time of enrollment

          -  Evidence of active pulmonary disease

          -  Live vaccinations within 3 months prior to the start of the study

          -  Use of forbidden therapy

        Other protocol-defined inclusion/exclusion criteria applied