Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Gout

In brief

The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide. The purpose of the first 12 week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2357. The purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.

Key facts

Study ID

NCT01080131

Run by

Novartis Pharmaceuticals

People needed

226

Starts

2010-03-01

Expected to finish

2011-10-01

Last updated by the study team

2014-01-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout
• Onset of current acute gout flare within 5 days prior to study entry
• Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
• History of ≥ 3 gout flares within the 12 months prior to study entry
• Contraindication, or intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAID) and/or colchicine

You may not qualify if…

• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
• Presence of severe renal function impairment
• Use of specified pain relief medications or biologics (corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor within specified periods prior to study entry
• Live vaccinations within 3 months prior to randomization
• Requirement for administration of antibiotics against latent tuberculosis (TB)
• Refractory heart failure (Stage D)
• Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
• Any active or recurrent bacterial, fungal, or viral infection
• Extension Study 1:
• Inclusion:
• Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7.
• Exclusion:
• Continuation in this extension study was considered inappropriate by the treating physician.
• Extension Study 2:
• Inclusion Criteria:
• Completion of the first extension study CACZ885H2357E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).
• Exclusion Criteria:
• Continuation in this second extension study was considered inappropriate by the treating physician.
• Other protocol-defined inclusion-exclusion criteria applied to the core and extension studies.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Novartis Investigative site — Foley, Alabama, United States
• Horizon Research Group, Inc. — Mobile, Alabama, United States
• Sun Valley Arthritis Center, Ltd — Peoria, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Little Rock Diagnostic Clinic — Little Rock, Arkansas, United States
• Providence Research — Burbank, California, United States
• Diagnamics, Inc. — Carlsbad, California, United States
• Med Investigations — Fair Oaks, California, United States
• Valerius Medical Group and Research Center of Long Branch — Long Beach, California, United States
• Lucita M. Cruz, M.D., Inc. — Norwalk, California, United States
• Sierra Clinical Research — Orangevale, California, United States
• Chaparral Medical Grp, INC Clinical Research — Pomona, California, United States
• River City Clinical Research — Sacramento, California, United States
• Arthritis Associates — San Antonio, California, United States
• California Research Foundation — San Diego, California, United States
• Rochester clinical Research — San Diego, California, United States
• Ritchken and First MDs — San Diego, California, United States
• Huntington Medical Foundation — San Marino, California, United States
• Crest Clinical Trials — Santa Ana, California, United States
• Orange County Research Center — Tustin, California, United States
• Progressive Clinical Research — Vista, California, United States
• Center for Clinical Trials of San Gabriel — West Covina, California, United States
• Clinical Res Ct of CT - Arthritis Associates of CT/NY, LLC — Danbury, Connecticut, United States
• Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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