Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors

Phase

Condition

Bone Diseases

Joint Injuries

Arthritis And Arthritic Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01508702

RDEA594-303

2011-003756-39

Ages 18-85
All Genders

Study Summary

This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.

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 meets the diagnosis of gout as per the American Rheumatism AssociationCriteria for the Classification of Acute Arthritis of Primary Gout.
Subject has an sUA level ≥ 6.5 mg/dL at the Screening and Day -7 Visits.
Subject must be able to take gout flare prophylaxis with colchicine or NSAID (including Cox-2 selective NSAID) ± PPI.
Subject has a history (either by medical record or subject interview) of intoleranceor a contraindication to either allopurinol or febuxostat.
Body mass index (BMI) < 45 kg/m2

Exclusion

Exclusion Criteria:

Subject who is taking any other approved urate-lowering medication that is indicatedfor the treatment of gout at the Screening Visit.
Subject with a documented history or suspicion of kidney stones.
Subject who is pregnant or breastfeeding.
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 that requires or may require systemic immunosuppressive or immunomodulatorytreatment.
Subject with a 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 Associationclass III or IV heart failure, myocardial infarction, stroke, or deep venousthrombosis; or subjects currently receiving anticoagulants.
Subject with uncontrolled hypertension.
Subject with an estimated creatinine clearance < 30 mL/min.
Subject with active peptic ulcer disease requiring treatment.
Subject with active liver disease, or hepatic dysfunction.
Subject receiving chronic treatment with more than 325 mg 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

January 01, 2012

November 30, 2013

Study Description

Allopurinol is the standard of care for the treatment of gout. In practice, approximately 20% of patients report side effects with allopurinol and 5% discontinue allopurinol due to side effects. Allopurinol can cause gastrointestinal intolerance, such as nausea and diarrhea, which appears to be dosedependent. Rash develops in about 2% of patients treated with allopurinol, and in about 20% of patients treated with allopurinol and ampicillin or amoxicillin. Allopurinol hypersensitivity syndrome remains a major concern among physicians. Mortality has been estimated to be up to nearly one quarter of AHS cases, with multiorgan system disease including hepatocellular changes and renal failure being a serious concern. Allopurinol is also relatively contraindicated for use in combination with 6-mercaptopurine and azathioprine, for which 1/4 to 1/3 lower doses must be given in order to avoid hematologic toxicity. Febuxostat, in clinical trials, has shown a similar AE profile to allopurinol. Liver function abnormalities, nausea, arthralgia and rash were the most commonly reported AEs. In postmarketing experience, Stevens Johnson Syndrome and hypersensitivity rashes have been reported (febuxostat prescribing information). Withdrawals due to AEs were similar in frequency to allopurinol as well. Relative contraindications in combination with 6-mercaptopurine and azathioprine are similar to allopurinol as well. Lesinurad may be an important therapeutic option for patients who either cannot tolerate or who have a contraindication to the use of allopurinol or febuxostat.

Connect with a study center

Butterfield, Queensland 4029
Australia
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Hobart, Tasmania 7000
Australia
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Tasmania, 7000
Australia
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Anderlecht, Brussels 1070
Belgium
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Genk, Limburg 3600
Belgium
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Gozee, 6534
Belgium
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Kortrijk, 8500
Belgium
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Yvoir, 5530
Belgium
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Coquitiam, British Columbia V3K 3P4
Canada
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Coquitlam, British Columbia V3K 3P4
Canada
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Victoria, British Columbia V8V 3N7
Canada
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London, Ontario N6A 5R8
Canada
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Mississauga, Ontario L5M 2V8
Canada
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Toronto, Ontario M9W 4L6
Canada
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Rimouski, Quebec G5L 8W1
Canada
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Quebec, G1V 3M7
Canada
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Dresden, Saxony 01307
Germany
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Leipzig, Saxony 04109
Germany
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Tauranga, Bay of Plenty 3143
New Zealand
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Auckland, 1010
New Zealand
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Durban, 4092
South Africa
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Pretoria, 0002
South Africa
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Rondebosch, 7700
South Africa
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Stellenbosch, 7600
South Africa
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Thabazimbi, 0380
South Africa
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Birmingham, Alabama 35211
United States
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Glendale, Arizona 85308
United States
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Phoenix, Arizona 85050
United States
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Tucson, Arizona 85724
United States
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Jonesboro, Arkansas 72401
United States
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Little Rock, Arkansas 72205
United States
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Anaheim, California 92805
United States
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Carmichael, California 95608
United States
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Covina, California 91723
United States
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Huntington Park, California 90255
United States
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Irvine, California 92618
United States
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Colorado Springs, Colorado 80922
United States
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Denver, Colorado 80230
United States
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Englewood, Colorado 80113
United States
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Milford, Connecticut 06460
United States
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Trumbull, Connecticut 06611
United States
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Boynton Beach, Florida 33472
United States
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Jacksonville, Florida 32216
United States
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Miami, Florida 33143
United States
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Plant City, Florida 33563
United States
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Port Orange, Florida 32127
United States
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Tampa, Florida 33607
United States
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Winter Haven, Florida 33880
United States
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Newman, Georgia 30265
United States
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Honolulu, Hawaii 96814
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Meridian, Idaho 83646
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Chicago, Illinois 60624
United States
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Elizabethtown, Kentucky 42701
United States
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Lexington, Kentucky 40504
United States
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Louisville, Kentucky 40213
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Metairie, Louisiana 70006
United States
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South Traverse, Michigan 49684
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Jackson, Mississippi 39202
United States
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Olive Branch, Mississippi 38654
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Southfield, Missouri 48034
United States
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Washington, Missouri 63090
United States
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Albuquerque, New Mexico 87102
United States
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Brooklyn, New York 11201
United States
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Hartsdale, New York 10530
United States
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New Windsor, New York 12553
United States
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New York, New York 10016
United States
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Hickory, North Carolina 28602
United States
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Raleigh, North Carolina 27612
United States
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Winston-Salem, North Carolina 27103
United States
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Fargo, North Dakota 58103
United States
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Cincinnati, Ohio 45224
United States
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Middleburgh Heights, Ohio 44130
United States
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Perrysburgh, Ohio 43551
United States
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Willoughby Hills, Ohio 44904
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Norman, Oklahoma 73069
United States
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Jenkintown, Pennsylvania 19046
United States
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Lancaster, Pennsylvania 17601
United States
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Lansdale, Pennsylvania 19446
United States
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Pittsburgh, Pennsylvania 15237
United States
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Reading, Pennsylvania 19606
United States
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Sellersville, Pennsylvania 18960
United States
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Myrtle Beach, South Carolina 29588
United States
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Rock Hill, South Carolina 29732
United States
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Spartanburg, South Carolina 29303
United States
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Brentwood, Tennessee 37027
United States
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Spring Hill, Tennessee 37174
United States
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Dallas, Texas 75235
United States
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Houston, Texas 77098
United States
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San Antonio, Texas 78229
United States
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Victoria, Texas 77901
United States
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South Bountiful, Utah 84010
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West Jordon, Utah 84088
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West Layton, Utah 84041
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Chesapeake, Virginia 23320
United States
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Richmond, Virginia 23235
United States
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Suffolk, Virginia 23435
United States
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Seattle, Washington 98104
United States
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Spokane, Washington 99208
United States
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Morgantown, West Virginia 26505
United States
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