Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients



Status:Recruiting
Conditions:Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:11/11/2012
Start Date:May 2011
Contact:Novartis Pharmaceuticals
Phone:862-778-8300

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A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients


This study will assess the safety and efficacy of canakinumab pre-filled syringes in
comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that
have frequent flares of acute gouty arthritis.


Inclusion criteria:

- 3 or more gout flares within last year

- Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine

- Body mass index of less than or equal to 45 kg/m2

Exclusion criteria:

- Use of the following therapies (within varying protocol defined timeframes):
corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs
(such as aspirin), colchicine.

- Hemodialysis

- Live vaccine within 3 months before first dose

- Donation or loss of 400 mL or more within 3 months before first dose

- Gout brought on by other factors such as chemotherapy, lead, transplant, etc.

- Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis

- Any conditions or significant medical problems that puts the patient at an
unacceptable immunological risk to receive this type of therapy such as HIV,
Hepatitis, Tuberculosis and other infections/conditions

- Significant cardiovascular conditions such as uncontrolled hypertension

- Significant medical diseases such as uncontrolled diabetes, thyroid disease

- History of malignancy of any organ system within the past 5 years

- Women who are pregnant or nursing

- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
72
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Omaha, Nebraska 68134
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175 Meadowbrook Lane
, Pennsylvania 16635
814-693-0300
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325 Winding River Lane
, Virginia 22911
434-817-2442
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1952 - 152nd Place NE
East Seattle, Washington 98007
425-453-0404
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404 Memorial Dr.
Greer, South Carolina 29651
864-848-9293
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1044 SW 44th Street
Oklahoma City, Oklahoma 73109
405-616-4888
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6600 Mercy Ct Fair Oaks
Sacramento, California 95628
916-966-7452
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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1202 Medical Center Dr.
Wilmington, North Carolina 28401
910-815-6108
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Anniston, Alabama 36207
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Asheville, North Carolina 28803
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Augusta, GA
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Belzoni, Mississippi 39038
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Boise, Idaho 83702
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Bountiful, Utah 84010
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Bristol, Tennessee 37620
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Buena Park, California
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Chandler, Arizona 85225
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Charleston, South Carolina 29412
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Charlotte, North Carolina 28277
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Charlotte, North Carolina 28209
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Chesapeake, Virginia 23320
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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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Columbus, Ohio 43212
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Dallas, Texas 75231
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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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Decatur, Georgia 30035
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East Point, Georgia 30344
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Fargo, North Dakota 58103
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Fayetteville, Tennessee 33734
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Foley, Alabama 36535
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Fort Mill, South Carolina 29707
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Freehold, New Jersey 07728
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Greensboro, North Carolina 27410
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Greensboro, North Carolina 27408
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Houston, TX
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Jackson, Mississippi 39209
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Jackson, Mississippi 39202
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Johnson City, Tennessee 37601
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Jupiter, Florida 33458
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Lake Success, New York 11042
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Lincoln, Nebraska 68512
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Louisville, Kentucky 40217
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Memphis, Tennessee 38125
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Metairie, Louisiana 70006
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Midlothian, Virginia 23114
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Missoula, Montana
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Mobile, Alabama 36608
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Murrells Inlet, South Carolina 29576
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Newport News, Virginia 23606
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North Richland Hills, Texas 76180
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Norwalk, California 90650
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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 68130
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Overland Park, Kansas 66215
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Owensboro, Kentucky 42303
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Picayune, Mississippi 39466
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Pinellas Park, Florida 33782
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Raleigh, North Carolina 27609
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Roseville, California 95661
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Roslyn, New York 11576
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Salisbury, North Carolina 28144
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San Marino, California 91108
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Shelby, North Carolina 28152
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South Miami, Florida 33143
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Troy, Michigan 48085
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Tucson, Arizona 85710
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Varnville, South Carolina 29924
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Westlake Village, California 91361
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