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

Condition(s) targeted: Acute Gout

Intervention: Canakinumab (Drug); Canakinumab (Drug); Canakinumab (Drug); Canakinumab (Drug); Canakinumab (Drug); Triamcinolone acetonide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novartis

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.

Official title: An Adaptive Dose-ranging, Multi-center, Single-blind, Double-dummy, Active-controlled Trial to Determine the Target Dose of Canakinumab (ACZ885) in the Treatment of Acute Flares in Gout Patients Who Are Refractory or Contraindicated to NSAIDs and/or Colchicine

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: The Dose of Canakinumab for Treatment of Acute Flares in Gout Patients That Leads to the Same Efficacy as Triamcinolone Acetonide With Respect to Pain Intensity on a 0-100 mm Visual Analog Scale (VAS)

Secondary outcome:

The Change in Pain Intensity in the Target Joint Following Canakinumab Administration Compared to Triamcinolone Acetonide

Percentage of Participants With an Excellent or Good Response With Regards to the Patient's Global Assessment of Response to Treatment

The Time to 50% Reduction of Baseline Pain Intensity in the Target Joint

High Sensitivity C-reactive Protein (hsCRP) at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group

Serum Amyloid Protein (SAA) Levels at 72 Hours, 7days, 4 Weeks and 8 Weeks Post Dose for Each Treatment Group

Amount of Rescue Medication Taken for Each Treatment Group

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Novartis Investigative site, Rosario, Argentina

Novartis Investigative site, Gozée, Belgium

Novartis Investigative site, Moncton, Canada

Novartis Investigative site, Mount Pearl, Canada

Novartis Investigative site, St. John's, Canada

Novartis Investigative site, Paris cedex 10, France

Novartis Investigative Site, Bad Nauheim, Germany

Novartis Investigative Site, Bautzen, Germany

Novartis Investigative Site, Berlin, Germany

Novartis Investigative Site, Chemnitz, Germany

Novartis Investigative Site, Dachau, Germany

Novartis Investigative Site, Dresden, Germany

Novartis Investigative Site, Frankfurt, Germany

Novartis Investigative Site, Georgensgmuend, Germany

Novartis Investigative Site, Hamburg, Germany

Novartis Investigative Site, Leipzig, Germany

Novartis Investigative Site, Loehne, Germany

Novartis Investigative Site, Magdeburg, Germany

Novartis Investigative Site, Messkirch, Germany

Novartis Investigative Site, Munich, Germany

Novartis Investigative Site, Schwabach, Germany

Novartis Investigative Site, Zerbst, Germany

Novartis Investigative site, Poznan, Poland

Novartis Investigative site, Szczecin, Poland

Novartis Investigative site, Wroclaw, Poland

Novartis Investigative site, Chelyabinsk, Russian Federation

Novartis Investigative Site, Moscow, Russian Federation

Novartis Investigative Site, St. Petersburg, Russian Federation

Novartis Investigative site, Tyumen, Russian Federation

Novartis Investigative Site, Yaroslavl, Russian Federation

Novartis Investigative site, Yekaterinburg, Russian Federation

Novartis Investigative site, Baden, Switzerland

Novartis Investigative site, Basel, Switzerland

Novartis Investigative site, Bern, Switzerland

Novartis Investigative site, Lausanne, Switzerland

Novartis Investigative Site, Adana, Turkey

Novartis Investigative Site, Ankara, Turkey

Novartis Investigative Site, Antalya, Turkey

Novartis Investigative Site, Aydin, Turkey

Novartis Investigative Site, Gaziantep, Turkey

Novartis Investigative Site, Istanbul, Turkey

Novartis Investigative Site, Izmir, Turkey

Novartis Investigative Site, Manisa, Turkey

Novartis Investigative site, Sihhiye/Ankara, Turkey

Novartis Investigative Site, Antrim, United Kingdom

Novartis Investigative Site, Coventry, United Kingdom

Novartis Investigative Site, Lancashire, United Kingdom

Novartis Investigative Site, Wellingborough, United Kingdom

Pinnacle Research Group, LLC, Anniston, Alabama 36207-5710, United States

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Associated Pharmaceutical Research, Buena Park, California 90620, United States

Northern California Institute for Bone Health, Oakland, California 94609, United States

San Diego Arthritis & Osteoporosis Medical Clinic, San Diego, California 92108, United States

Center for Clinical Trials of San Gabriel, West Covina, California 91790, United States

Tampa Medical Group, P.A., Tampa, Florida 33614, United States

Florida Medical Clinic, PA, Zephyrhills, Florida 33542, United States

Harbin Clinic, Rome, Georgia 30165, United States

Intermountain Orthopedics, Boise, Idaho 83702, United States

Northwest Clinical Trials, Boise, Idaho 83704, United States

The Arthritis Center, Springfield, Illinois 62704, United States

Cotton O'Neil Clinic, Topeka, Kansas 66606, United States

Arthritis and Diabetes Clinic, Monroe, Louisiana 71203, United States

Arthritis Consultants, Inc., St. Louis, Missouri 63141, United States

Billings Clinic Research Center, Billings, Montana 59101, United States

Montana Medical Research, Missoula, Montana 59804, United States

Heartland Clinical Research, Inc., Omaha, Nebraska 68134, United States

New Mexico Clinical Research & Osteoporosis Center, Inc., Albuquerque, New Mexico 87106, United States

Regional Clinical Research Rheumatology Assoc., Binghamton, New York 13905, United States

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

Community Research Partners, Inc., Varnville, South Carolina 29944, United States

Comprehensive Rheumatology, Hendersonville, Tennessee 37075, United States

MultiSpecialty Clinical Research, Johnson City, Tennessee 37601, United States

Integrity Clinical Research, LLC, Milan, Tennessee 38358, United States

Southwest Rheumatology, Mesquite, Texas 75150, United States

Health Research of Hampton Roads, Newport News, Virginia 23606, United States

Starting date: November 2008
Last updated: April 9, 2012