Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat (CRYSTAL)
Primary Purpose
Tophaceous Gout
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lesinurad
Lesinurad
Placebo
Febuxostat
Sponsored by
About this trial
This is an interventional treatment trial for Tophaceous Gout
Eligibility Criteria
Inclusion Criteria:
- Subject is able to understand the study procedures, the risks involved and willing to provide 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 ≥ 8 mg/dL (476 µmol/L).
- Subjects entering the study on a medically appropriate dose of febuxostat or allopurinol 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-steroidal anti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.
- Subject with at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 20 mm in the longest diameter.
- Body mass index (BMI) < 45 kg/m2
Exclusion Criteria:
- Subject with known hypersensitivity or allergy to febuxostat.
- Subject who is taking any approved urate-lowering medication other than allopurinol or febuxostat that is indicated for the treatment of gout within 8 weeks of the Screening Visit.
- Subject who previously received pegloticase.
- Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] 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 immunomodulatory treatment.
- 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 of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.
- Subject within the last 12 months with: unstable angina, New York Heart Association thrombosis; 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 the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
lesinurad 400 mg + febuxostat 80 mg
lesinurad 200 mg + febuxostat 80 mg
placebo + febuxostat 80 mg
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Complete Resolution of at Least One Target Tophus
Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12
Complete or Partial Response of at Least One Tophus
Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12
Quality of Life
Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient's level of functional ability with items scores ranging from 0-3 with 0 being the least disability.
Full Information
NCT ID
NCT01510769
First Posted
January 12, 2012
Last Updated
April 20, 2016
Sponsor
Ardea Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01510769
Brief Title
Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
Acronym
CRYSTAL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ardea Biosciences, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tophaceous Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lesinurad 400 mg + febuxostat 80 mg
Arm Type
Experimental
Arm Title
lesinurad 200 mg + febuxostat 80 mg
Arm Type
Experimental
Arm Title
placebo + febuxostat 80 mg
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lesinurad
Intervention Description
Tablets, 400 mg once daily (QD)
Intervention Type
Drug
Intervention Name(s)
Lesinurad
Intervention Description
Tablets, 200 mg QD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Placebo QD
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Intervention Description
80 mg
Primary Outcome Measure Information:
Title
Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6
Description
Proportion of subjects with an sUA level that is < 5.0 mg/dL by Month 6
Time Frame
6 months, analysis after all subjects complete 12 months
Secondary Outcome Measure Information:
Title
Complete Resolution of at Least One Target Tophus
Description
Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12
Time Frame
12 Months
Title
Complete or Partial Response of at Least One Tophus
Description
Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12
Time Frame
12 Months
Title
Quality of Life
Description
Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient's level of functional ability with items scores ranging from 0-3 with 0 being the least disability.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is able to understand the study procedures, the risks involved and willing to provide 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 ≥ 8 mg/dL (476 µmol/L).
Subjects entering the study on a medically appropriate dose of febuxostat or allopurinol 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-steroidal anti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.
Subject with at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 20 mm in the longest diameter.
Body mass index (BMI) < 45 kg/m2
Exclusion Criteria:
Subject with known hypersensitivity or allergy to febuxostat.
Subject who is taking any approved urate-lowering medication other than allopurinol or febuxostat that is indicated for the treatment of gout within 8 weeks of the Screening Visit.
Subject who previously received pegloticase.
Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] 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 immunomodulatory treatment.
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 of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.
Subject within the last 12 months with: unstable angina, New York Heart Association thrombosis; 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 the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Storgard, MD
Organizational Affiliation
Ardea Biosciences, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
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Austin
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Australia
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Australia
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Canada
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Victoria
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British Columbia
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Canada
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Halifax
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Nova Scotia
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Canada
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London
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Ontario
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Canada
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Mississauga
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Ontario
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Canada
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Toronto
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Ontario
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Quebec
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Canada
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Grafton
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Auckland
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1010
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New Zealand
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Tauranga
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Bay of Plenty
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3143
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New Zealand
City
Hamilton
ZIP/Postal Code
3240
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New Zealand
City
Kutno
State/Province
Lodz Province
ZIP/Postal Code
99-300
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Poland
City
Biatystok
ZIP/Postal Code
15-430
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Poland
City
Elblag
ZIP/Postal Code
82-300
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Poland
City
Katowice
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40-954
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Poland
City
Konskie
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26-200
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Poland
City
Krakow
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30-510
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Poland
City
Krakow
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31-501
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Poland
City
Poznan
ZIP/Postal Code
60-539
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Poland
City
Poznan
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60-773
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Poland
City
Lausanne
State/Province
Vlaud
ZIP/Postal Code
1011
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Switzerland
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35835008
Citation
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.
Results Reference
derived
PubMed Identifier
30616614
Citation
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.
Results Reference
derived
PubMed Identifier
28597604
Citation
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.
Results Reference
derived
Links:
URL
http://www.gouttrial.com
Description
Related Info
Learn more about this trial
Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
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