Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Gout

In brief

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.

Key facts

Study ID

NCT00798369

Run by

Novartis

People needed

200

Starts

2008-11-01

Expected to finish

2009-08-01

Last updated by the study team

2012-04-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Associated Pharmaceutical Research — Buena Park, California, United States
• Northern California Institute for Bone Health — Oakland, California, United States
• San Diego Arthritis & Osteoporosis Medical Clinic — San Diego, California, United States
• Center for Clinical Trials of San Gabriel — West Covina, California, United States
• Tampa Medical Group, P.A. — Tampa, Florida, United States
• Florida Medical Clinic, PA — Zephyrhills, Florida, United States
• Harbin Clinic — Rome, Georgia, United States
• Intermountain Orthopedics — Boise, Idaho, United States
• Northwest Clinical Trials — Boise, Idaho, United States
• The Arthritis Center — Springfield, Illinois, United States
• Cotton O'Neil Clinic — Topeka, Kansas, United States
• Arthritis and Diabetes Clinic — Monroe, Louisiana, United States
• Arthritis Consultants, Inc. — St Louis, Missouri, United States
• Billings Clinic Research Center — Billings, Montana, United States
• Montana Medical Research — Missoula, Montana, United States
• Heartland Clinical Research, Inc. — Omaha, Nebraska, United States
• New Mexico Clinical Research & Osteoporosis Center, Inc. — Albuquerque, New Mexico, United States
• Regional Clinical Research Rheumatology Assoc. — Binghamton, New York, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Community Research Partners, Inc. — Varnville, South Carolina, United States
• Comprehensive Rheumatology — Hendersonville, Tennessee, United States
• MultiSpecialty Clinical Research — Johnson City, Tennessee, United States
• Integrity Clinical Research, LLC — Milan, Tennessee, United States
• Pinnacle Research Group, LLC — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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