CRYSTAL
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects With Tophaceous Gout
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
330
6 countries
124
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 12, 2012
Actual (reported)January 16, 2012
Actual (reported)June 2014
Actual (reported)June 2014
Actual (reported)May 26, 2016
Actual (reported)Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6
Proportion of subjects with an sUA level that is \< 5.0 mg/dL by Month 6
6 months, analysis after all subjects complete 12 months
Complete Resolution of at Least One Target Tophus
12 Months
Complete or Partial Response of at Least One Tophus
12 Months
Quality of Life
12 Months
Tablets, 400 mg once daily (QD)
Tablets, 200 mg QD
Birmingham, Alabama, 35211, United States
Goodyear, Arizona, 85395, United States
Peoria, Arizona, 85381, United States
Pheonix, Arizona, 85023, United States
Tucson, Arizona, 85724, United States
Little Rock, Arkansas, 72204, United States
Little Rock, Arkansas, 72223, United States
Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29.
Dalbeth N, Jones G, Terkeltaub R, Khanna D, Fung M, Baumgartner S, Perez-Ruiz F. Efficacy and safety during extended treatment of lesinurad in combination with febuxostat in patients with tophaceous gout: CRYSTAL extension study. Arthritis Res Ther. 2019 Jan 7;21(1):8. doi: 10.1186/s13075-018-1788-4.
Chris Storgard, MD
Ardea Biosciences, Inc.
330 participants (actual enrollment reported by the registry).
First Submitted
January 12, 2012
First Posted
January 16, 2012
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Lesinurad and Allopurinol Combination Extension Study in Gout
Tablets, Placebo QD
80 mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Glendale, California, 91204, United States
Huntington Beach, California, 92646, United States
Irvine, California, 92618, United States
La Jolla, California, 92037, United States
Los Angeles, California, 90048, United States
Rancho Cucamonga, California, 91730, United States
San Diego, California, 92108, United States
Denver, Colorado, 80220, United States
Denver, Colorado, 80230, United States
Englewood, Colorado, 80113, United States
Trumball, Connecticut, 06611, United States
Washington D.C., District of Columbia, 20422, United States
Boynton Beach, Florida, 33472, United States
Brooksville, Florida, 34601, United States
East Brandenton, Florida, 34208, United States
Fleming Island, Florida, 32003, United States
Miami, Florida, 33135, United States
Napels, Florida, 34102, United States
Pembroke Pines, Florida, 33027, United States
Pembroke Pines, Florida, 33029, United States
Port Orange, Florida, 32127, United States
Tampa, Florida, 33606, United States
Tampa, Florida, 33607, United States
Tampa, Florida, 33614, United States
Vero Beach, Florida, 32960, United States
Winter Haven, Florida, 33880, United States
Conyers, Georgia, 30013, United States
Johns Creek, Georgia, 30097, United States
Newnan, Georgia, 30265, United States
Savannah, Georgia, 31406, United States
Honolulu, Hawaii, 96814, United States
Meridian, Idaho, 83642, United States
Meridian, Idaho, 83646, United States
Chicago, Illinois, 60624, United States
Chicago, Illinois, 60637, United States
Gurnee, Illinois, 60031, United States
Springfield, Illinois, 62704, United States
Springfield, Illinois, 62711, United States
Elizabethtown, Kentucky, 42701, United States
Lexington, Kentucky, 40504, United States
Frederick, Maryland, 21702, United States
Kalamazoo, Michigan, 49009, United States
Southfield, Michigan, 48034, United States
Jackson, Mississippi, 39202, United States
Olive Branch, Mississippi, 38654, United States
Jefferson City, Missouri, 65109, United States
St Louis, Missouri, 63117, United States
Missoula, Montana, 59808, United States
Mineola, New York, 11501, United States
New York, New York, 10016, United States
Calabash, North Carolina, 28467, United States
Durham, North Carolina, 27710, United States
Greenville, North Carolina, 27834, United States
Wilmington, North Carolina, 28401, United States
Winston-Salem, North Carolina, 27103, United States
Fargo, North Dakota, 58103, United States
Columbus, Ohio, 43203, United States
Middleburg, Ohio, 44130, United States
Wadsworth, Ohio, 44281, United States
Oklahoma City, Oklahoma, 73103, United States
Oklahoma City, Oklahoma, 73112, United States
Belle Vernon, Pennsylvania, 15012, United States
Clairton, Pennsylvania, 15025, United States
Duncansville, Pennsylvania, 16635, United States
Jenkintown, Pennsylvania, 19046, United States
Lansdale, Pennsylvania, 19446, United States
Pittsburgh, Pennsylvania, 15206, United States
Scottdale, Pennsylvania, 15683, United States
Sellersville, Pennsylvania, 18960, United States
Columbia, South Carolina, 29204, United States
Greenville, South Carolina, 29615, United States
Mt. Pleasant, South Carolina, 29464, United States
Spartanburg, South Carolina, 29303, United States
Jackson, Tennessee, 38305, United States
Memphis, Tennessee, 38119, United States
Austin, Texas, 78705, United States
Austin, Texas, 78758, United States
Corpus Christi, Texas, 78413, United States
Dallas, Texas, 75218, United States
Houston, Texas, 77004, United States
Houston, Texas, 77074, United States
San Antonio, Texas, 78229, United States
Sugar Land, Texas, 77479, United States
Victoria, Texas, 77901, United States
Waco, Texas, 76708, United States
Chesapeake, Virginia, 23320, United States
Danville, Virginia, 24541, United States
Richmond, Virginia, 23235, United States
Suffolk, Virginia, 23435, United States
Virginia Beach, Virginia, 23462, United States
Seattle, Washington, 98104, United States
Morgantown, West Virginia, 26505, United States
Camperdown, New South Wales, 2050, Australia
Woodville South, South Australia, 5011, Australia
Hobart, Tasmania, 7000, Australia
Shenton Park, Western Australia, 6008, Australia
Kelowna, British Columbia, V1Y 3G8, Canada
Victoria, British Columbia, V8V 3N7, Canada
Halifax, Nova Scotia, B3K 2M5, Canada
London, Ontario, N6A 5R8, Canada
Mississauga, Ontario, L5M 2V8, Canada
Toronto, Ontario, M9W 4L6, Canada
Québec, Quebec, G1V 3M7, Canada
Grafton, Auckland, 1010, New Zealand
Tauranga, Bay of Plenty, 3143, New Zealand
Hamilton, 3240, New Zealand
Kutno, Lodz Province, 99-300, Poland
Biatystok, 15-430, Poland
Elblag, 82-300, Poland
Gmina Końskie, 26-200, Poland
Katowice, 40-954, Poland
Krakow, 30-510, Poland
Krakow, 31-501, Poland
Poznan, 60-539, Poland
Poznan, 60-773, Poland
Lausanne, Vlaud, 1011, Switzerland
Fribourg, 1708, Switzerland
Dalbeth N, Jones G, Terkeltaub R, Khanna D, Kopicko J, Bhakta N, Adler S, Fung M, Storgard C, Baumgartner S, Perez-Ruiz F. Lesinurad, a Selective Uric Acid Reabsorption Inhibitor, in Combination With Febuxostat in Patients With Tophaceous Gout: Findings of a Phase III Clinical Trial. Arthritis Rheumatol. 2017 Sep;69(9):1903-1913. doi: 10.1002/art.40159. Epub 2017 Aug 4.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
May 26, 2016
Results First Posted
May 26, 2016
Record last verified: 2016-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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