Phase
Condition
Gout (Hyperuricemia)
Joint Injuries
Arthritis And Arthritic Pain (Pediatric)
Treatment
N/AClinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is able to understand the study procedures, the risks involved and willing toprovide written informed consent before the first study related activity.
Subject is willing to adhere to the visit/protocol schedules.
Subject meets the diagnosis of gout as per the American Rheumatism Association
Criteria for the Classification of Acute Arthritis of Primary Gout.
Subject meets one of the following criteria:
Subjects who are not currently taking an approved ULT must have an sUA value of ≥ 8mg/dL (476 µmol/L).
Subjects entering the study on a medically appropriate dose of febuxostat orallopurinol must have an sUA value of ≥ 6.0 mg/dL (357 µmol/L).
Subject must be able to take gout flare prophylaxis with colchicine or non-steroidalanti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.
Subject with at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5mm and ≤ 20 mm in the longest diameter.
Body mass index (BMI) < 45 kg/m2
Exclusion
Exclusion Criteria:
Subject with known hypersensitivity or allergy to febuxostat.
Subject who is taking any approved urate-lowering medication other than allopurinol orfebuxostat that is indicated for the treatment of gout within 8 weeks of the ScreeningVisit.
Subject who previously received pegloticase.
Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
Subject with a history or suspicion of drug abuse within the past 5 years.
Subject with a history of myositis/myopathy or rhabdomyolysis.
Subject that requires or may require systemic immunosuppressive or immunomodulatorytreatment.
Subject with known or suspected human immunodeficiency virus (HIV) infection.
Subject with a positive test for active hepatitis B or hepatitis C infection.
Subject with a history of malignancy within the previous 5 years with the exception ofnon-melanoma skin cancer that has been treated with no evidence of recurrence, treatedcervical dysplasia or treated in situ Grade 1 cervical cancer.
Subject within the last 12 months with: unstable angina, New York Heart Associationthrombosis; or subjects currently receiving anticoagulants.
Subject with uncontrolled hypertension.
Subject with an estimated creatinine clearance < 30 mL/min.
Subjects with a creatine kinase > 2.5 x ULN at any time during the Screening Period.
Subject with active peptic ulcer disease requiring treatment.
Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.
Subject receiving chronic treatment with more than 325 mg of salicylates per day.
Subject taking valpromide, progabide, or valproic acid.
Subject who has received an investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit.
Subject with any other medical or psychological condition, which in the opinion of theInvestigator and/or Medical Monitor, might create undue risk to the subject orinterfere with the subject's ability to comply with the protocol requirements, or tocomplete the study.
Study Design
Study Description
Connect with a study center
Camperdown, New South Wales 2050
AustraliaSite Not Available
Woodville South, South Australia 5011
AustraliaSite Not Available
Hobart, Tasmania 7000
AustraliaSite Not Available
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Clayton, Victoria 3168
AustraliaSite Not Available
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Heidelberg West, Victoria 3081
AustraliaSite Not Available
Shenton Park, Western Australia 6008
AustraliaSite Not Available
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Kamloops, British Columbia V2C 1K7
CanadaSite Not Available
Kelowna, British Columbia V1Y 3G8
CanadaSite Not Available
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Penticton, British Columbia V2A 5C8
CanadaSite Not Available
Victoria, British Columbia V8V 3N7
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Halifax, Nova Scotia B3K 2M5
CanadaSite Not Available
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Corunna, Ontario N0N 1G0
CanadaSite Not Available
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Kitchener, Ontario N2M 5N6
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London, Ontario N6A 5R8
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Mississauga, Ontario L5M 2V8
CanadaSite Not Available
Toronto, Ontario M9W 4L6
CanadaSite Not Available
Quebec, G1V 3M7
CanadaSite Not Available
Grafton, Auckland 1010
New ZealandSite Not Available
Tauranga, Bay of Plenty 3143
New ZealandSite Not Available
Hamilton, 3240
New ZealandSite Not Available
Kutno, Lodz Province 99-300
PolandSite Not Available
Biatystok, 15-430
PolandSite Not Available
Elblag, 82-300
PolandSite Not Available
Katowice, 40-954
PolandSite Not Available
Konskie, 26-200
PolandSite Not Available
Krakow, 30-510
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Poznan, 60-773
PolandSite Not Available
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Wroclaw, 53-025
PolandSite Not Available
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Barakaldo, 48903
SpainSite Not Available
Lausanne, Vlaud 1011
SwitzerlandSite Not Available
Fribourg, 1708
SwitzerlandSite Not Available
Birmingham, Alabama 35211
United StatesSite Not Available
empty
Mobile, Alabama 36608
United StatesSite Not Available
Goodyear, Arizona 85395
United StatesSite Not Available
Peoria, Arizona 85381
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Pheonix, Arizona 85023
United StatesSite Not Available
Tucson, Arizona 85724
United StatesSite Not Available
Little Rock, Arkansas 72204
United StatesSite Not Available
empty
Covina, California 91723
United StatesSite Not Available
Glendale, California 91204
United StatesSite Not Available
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Hemet, California 92543
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Huntington Beach, California 92646
United StatesSite Not Available
empty
Huntington Park, California 90255
United StatesSite Not Available
empty
Inglewood, California 90301
United StatesSite Not Available
Irvine, California 92618
United StatesSite Not Available
La Jolla, California 92037
United StatesSite Not Available
empty
Lakewood, California 90712
United StatesSite Not Available
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Lancaster, California 93534
United StatesSite Not Available
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Long Beach, California 90807
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Los Angeles, California 90048
United StatesSite Not Available
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Orange, California 92868
United StatesSite Not Available
Rancho Cucamonga, California 91730
United StatesSite Not Available
San Diego, California 92108
United StatesSite Not Available
Denver, Colorado 80230
United StatesSite Not Available
Englewood, Colorado 80113
United StatesSite Not Available
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Milford, Connecticut 06460
United StatesSite Not Available
Trumball, Connecticut 06611
United StatesSite Not Available
Washington, District of Columbia 20422
United StatesSite Not Available
empty
Washington DC, District of Columbia 20060
United StatesSite Not Available
Boynton Beach, Florida 33472
United StatesSite Not Available
Brooksville, Florida 34601
United StatesSite Not Available
East Brandenton, Florida 34208
United StatesSite Not Available
Fleming Island, Florida 32003
United StatesSite Not Available
Miami, Florida 33135
United StatesSite Not Available
Napels, Florida 34102
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Pembroke Pines, Florida 33027
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Port Orange, Florida 32127
United StatesSite Not Available
empty
South Jacksonville, Florida 32205
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Tampa, Florida 33607
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Vero Beach, Florida 32960
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Winter Haven, Florida 33880
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Atlanta, Georgia 30308
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Conyers, Georgia 30013
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Decatur, Georgia 30033
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Dunwoody, Georgia 30338
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Johns Creek, Georgia 30097
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Marietta, Georgia 30060
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Newman, Georgia 30265
United StatesSite Not Available
empty
Roswell, Georgia 30075
United StatesSite Not Available
Savannah, Georgia 31406
United StatesSite Not Available
Honolulu, Hawaii 96814
United StatesSite Not Available
Meridian, Idaho 83642
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Chicago, Illinois 60637
United StatesSite Not Available
Gurnee, Illinois 60031
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Springfield, Illinois 62711
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LaPorte, Indiana 46350
United StatesSite Not Available
Elizabethtown, Kentucky 42701
United StatesSite Not Available
Lexington, Kentucky 40504
United StatesSite Not Available
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Baton Rouge, Louisiana 70809
United StatesSite Not Available
Frederick, Maryland 21702
United StatesSite Not Available
empty
Fall River, Massachusetts 02720
United StatesSite Not Available
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Ann Arbor, Michigan 48109
United StatesSite Not Available
Kalamazoo, Michigan 49009
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Southfield, Michigan 48034
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Jackson, Mississippi 39202
United StatesSite Not Available
Olive Branch, Mississippi 38654
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Jefferson City, Missouri 65109
United StatesSite Not Available
Saint Louis, Missouri 63117
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Missoula, Montana 59808
United StatesSite Not Available
empty
Las Vegas, Nevada 89119
United StatesSite Not Available
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Albuquerque, New Mexico 87102
United StatesSite Not Available
empty
Brooklyn, New York 11201
United StatesSite Not Available
Mineola, New York 11501
United StatesSite Not Available
New York, New York 10016
United StatesSite Not Available
Calabash, North Carolina 28467
United StatesSite Not Available
empty
Charlotte, North Carolina 28205
United StatesSite Not Available
Durham, North Carolina 27710
United StatesSite Not Available
Wilmington, North Carolina 28401
United StatesSite Not Available
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Fargo, North Dakota 58103
United StatesSite Not Available
Columbus, Ohio 43203
United StatesSite Not Available
Middleburg, Ohio 44130
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Wadsworth, Ohio 44281
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Oklahoma City, Oklahoma 73103
United StatesSite Not Available
empty
Ashland, Oregon 97520
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Belle Vernon, Pennsylvania 15012
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Clairton, Pennsylvania 15025
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Duncansville, Pennsylvania 16635
United StatesSite Not Available
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Indiana, Pennsylvania 15701
United StatesSite Not Available
Jenkintown, Pennsylvania 19046
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Lansdale, Pennsylvania 19446
United StatesSite Not Available
Pittsburgh, Pennsylvania 15206
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Scottdale, Pennsylvania 15683
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Sellersville, Pennsylvania 18960
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Columbia, South Carolina 29204
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Greenville, South Carolina 29615
United StatesSite Not Available
Mount Pleasant, South Carolina 29464
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Spartanburg, South Carolina 29303
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Chattanooga, Tennessee 37404
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Memphis, Tennessee 38119
United StatesSite Not Available
Austin, Texas 78758
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Corpus Christi, Texas 78413
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Dallas, Texas 75218
United StatesSite Not Available
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El Paso, Texas 79902
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Houston, Texas 77074
United StatesSite Not Available
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Mesquite, Texas 75150
United StatesSite Not Available
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Missouri City, Texas 77489
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San Antonio, Texas 78229
United StatesSite Not Available
Sugar Land, Texas 77479
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Victoria, Texas 77901
United StatesSite Not Available
Waco, Texas 76708
United StatesSite Not Available
Chesapeake, Virginia 23320
United StatesSite Not Available
Danville, Virginia 24541
United StatesSite Not Available
Richmond, Virginia 23235
United StatesSite Not Available
Suffolk, Virginia 23435
United StatesSite Not Available
Virginia Beach, Virginia 23462
United StatesSite Not Available
Seattle, Washington 98104
United StatesSite Not Available
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Spokane, Washington 99208
United StatesSite Not Available
Morgantown, West Virginia 26505
United StatesSite Not Available
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Milwaukee, Wisconsin 53226
United StatesSite Not Available
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Monroe, Wisconsin 53566
United StatesSite Not Available
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