Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use NSAIDs and/or Colchicine.



Status:Recruiting
Conditions:Gout
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 85
Updated:3/30/2013
Start Date:August 2010
Contact:Novartis Pharmaceuticals
Phone:+41-61-324-1111

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An Open-label Extension Study of CACZ885H2357E1 on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective


The purpose of this second extension study is to collect long-term safety and tolerability
data and additional efficacy data in patients who are treated on demand upon flare with
canakinumab.


Inclusion Criteria:

Patients who have either:

- Completed the first extension study CACZ885H2357E1 or

- Experienced a ninth new flare within the core study CACZ885H2357 and the first
extension study CACZ885H2357E1

Exclusion Criteria:

- Continuation in this extension study is considered inappropriate by the treating
physician

- Pregnant or nursing (lactating) women

- Female patients being physiologically capable of becoming pregnant UNLESS they are
using an acceptable method of contraception with a failure rate (Pearl Index (PI)) <
1 Other protocol defined inclusion/exclusion criteria may apply.
We found this trial at
38
sites
1044 SW 44th Street
Oklahoma City, Oklahoma 73109
405-616-4888
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175 Meadowbrook Lane
, Pennsylvania 16635
814-693-0300
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1700 Abbey Place
1, Charlotte, North Carolina 28209
704-527-6672
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Baton Rouge, Louisiana 70809
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Baton Rouge, Louisiana 70808
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Boise, Idaho 83702
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Bristol, Tennessee 37620
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Burbank, California 91505
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Charleston, South Carolina 29407
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Clarkston, Michigan
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Clarksville, Tennessee 37043
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Clearwater, Florida 33756
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Columbia, South Carolina 29204
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142 S Main St
Danville, Virginia 24541
(434) 799-2100
Danville Regional Medical Center For more than 120 years, Danville Regional Medical Center has been...
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Dayton, Ohio 45417
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Decatur, Georgia 30035
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East Point, Georgia 30344
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Flint, Michigan 48532
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Jackson, Mississippi 39209
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Johnson City, Tennessee 37601
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Jupiter, Florida 33458
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Lake Jackson, Texas 77566
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Lansing, Michigan 48910
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Metairie, Louisiana 70006
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Mobile, Alabama 36608
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Newport News, Virginia 23606
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Omaha, Nebraska 68134
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Overland Park, Kansas 66215
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Pomona, CA
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Sacramento, California 95816
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Shelby, North Carolina 28150
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Shreveport, Louisiana 71106
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Tampa, Florida 33614
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Troy, Michigan 48085
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Tustin, California
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Varnville, South Carolina 29924
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Wichita, Kansas 67208
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