Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat

Last updated: April 20, 2016
Sponsor: Ardea Biosciences, Inc.
Overall Status: Completed

Phase

3

Condition

Gout (Hyperuricemia)

Joint Injuries

Arthritis And Arthritic Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01510769
RDEA594-304
2011-003768-55
  • Ages 18-85
  • All Genders

Study Summary

This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.

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

Total Participants: 330
Study Start date:
January 01, 2012
Estimated Completion Date:
June 30, 2014

Study Description

Febuxostat is an XO (Xanthine Oxidase) Inhibitor approved Urate Lowering Therapy (ULT) for patients with gout. Although febuxostat has been demonstrated to be superior to allopurinol in lowering serum urate (sUA) to < 6mg/dL in 3 randomized, controlled clinical trials, proportions of subjects experiencing a reduction in tophus area and gout flares were not significantly different compared to allopurinol. Although this study will allow subjects who are naïve to ULT to enroll, it is anticipated that the majority of subjects will currently be taking or have previously experienced XO Inhibitor therapy. This trial will enroll a population of subjects with high uric acid body burden, as all must demonstrate the presence of tophi.

Connect with a study center

  • Camperdown, New South Wales 2050
    Australia

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  • Woodville South, South Australia 5011
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  • Hobart, Tasmania 7000
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    Clayton, Victoria 3168
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    Heidelberg West, Victoria 3081
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  • Shenton Park, Western Australia 6008
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    Kamloops, British Columbia V2C 1K7
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  • Kelowna, British Columbia V1Y 3G8
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    Penticton, British Columbia V2A 5C8
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  • Victoria, British Columbia V8V 3N7
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  • Halifax, Nova Scotia B3K 2M5
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    Corunna, Ontario N0N 1G0
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    Kitchener, Ontario N2M 5N6
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  • London, Ontario N6A 5R8
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  • Mississauga, Ontario L5M 2V8
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  • Toronto, Ontario M9W 4L6
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  • Quebec, G1V 3M7
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  • Grafton, Auckland 1010
    New Zealand

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  • Tauranga, Bay of Plenty 3143
    New Zealand

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  • Hamilton, 3240
    New Zealand

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  • Kutno, Lodz Province 99-300
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  • Biatystok, 15-430
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  • Elblag, 82-300
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  • Katowice, 40-954
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  • Konskie, 26-200
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  • Krakow, 30-510
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  • Poznan, 60-773
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    Wroclaw, 53-025
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    Barakaldo, 48903
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  • Lausanne, Vlaud 1011
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    Mobile, Alabama 36608
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    Covina, California 91723
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    Orange, California 92868
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    Washington DC, District of Columbia 20060
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    Atlanta, Georgia 30308
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    Dunwoody, Georgia 30338
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    Marietta, Georgia 30060
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  • Newman, Georgia 30265
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    Roswell, Georgia 30075
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  • Savannah, Georgia 31406
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  • Honolulu, Hawaii 96814
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  • Meridian, Idaho 83642
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  • Chicago, Illinois 60637
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  • Gurnee, Illinois 60031
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    LaPorte, Indiana 46350
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    Baton Rouge, Louisiana 70809
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    Ann Arbor, Michigan 48109
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  • Jackson, Mississippi 39202
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    Las Vegas, Nevada 89119
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    Brooklyn, New York 11201
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  • Calabash, North Carolina 28467
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    Charlotte, North Carolina 28205
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  • Wilmington, North Carolina 28401
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  • Winston-Salem, North Carolina 27103
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  • Fargo, North Dakota 58103
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  • Columbus, Ohio 43203
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  • Middleburg, Ohio 44130
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  • Wadsworth, Ohio 44281
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  • Oklahoma City, Oklahoma 73103
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    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
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    Indiana, Pennsylvania 15701
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  • Jenkintown, Pennsylvania 19046
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  • Lansdale, Pennsylvania 19446
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  • 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
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  • 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
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  • Austin, Texas 78758
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  • Corpus Christi, Texas 78413
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  • Dallas, Texas 75218
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    El Paso, Texas 79902
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  • Houston, Texas 77074
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    Mesquite, Texas 75150
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  • Victoria, Texas 77901
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  • Waco, Texas 76708
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  • Chesapeake, Virginia 23320
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  • Danville, Virginia 24541
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  • Richmond, Virginia 23235
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  • Suffolk, Virginia 23435
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  • Virginia Beach, Virginia 23462
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  • Seattle, Washington 98104
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    Spokane, Washington 99208
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    Milwaukee, Wisconsin 53226
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    Monroe, Wisconsin 53566
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