Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01510769




Trial ID
NCT01510769
Ethics application status
Date submitted
12/01/2012
Date registered
13/01/2012
Date last updated
20/04/2016

Titles & IDs
Public title
Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
Scientific 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
Secondary ID [1] 0 0
2011-003768-55
Secondary ID [2] 0 0
RDEA594-304
Universal Trial Number (UTN)
Trial acronym
CRYSTAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tophaceous Gout 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lesinurad
Treatment: Drugs - Lesinurad
Treatment: Drugs - Placebo
Treatment: Drugs - Febuxostat

Experimental: lesinurad 400 mg + febuxostat 80 mg -

Experimental: lesinurad 200 mg + febuxostat 80 mg -

Placebo Comparator: placebo + febuxostat 80 mg -


Treatment: Drugs: Lesinurad
Tablets, 400 mg once daily (QD)

Treatment: Drugs: Lesinurad
Tablets, 200 mg QD

Treatment: Drugs: Placebo
Tablets, Placebo QD

Treatment: Drugs: Febuxostat
80 mg

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
6 months, analysis after all subjects complete 12 months
Secondary outcome [1] 0 0
Complete Resolution of at Least One Target Tophus - Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12
Timepoint [1] 0 0
12 Months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
12 Months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
12 Months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,WA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Woodville South
Recruitment hospital [3] 0 0
- Hobart
Recruitment hospital [4] 0 0
- Shenton Park
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
6008 - Shenton Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Idaho
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
North Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Washington
Country [30] 0 0
United States of America
State/province [30] 0 0
West Virginia
Country [31] 0 0
Canada
State/province [31] 0 0
British Columbia
Country [32] 0 0
Canada
State/province [32] 0 0
Nova Scotia
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
New Zealand
State/province [35] 0 0
Auckland
Country [36] 0 0
New Zealand
State/province [36] 0 0
Bay of Plenty
Country [37] 0 0
New Zealand
State/province [37] 0 0
Hamilton
Country [38] 0 0
Poland
State/province [38] 0 0
Lodz Province
Country [39] 0 0
Poland
State/province [39] 0 0
Biatystok
Country [40] 0 0
Poland
State/province [40] 0 0
Elblag
Country [41] 0 0
Poland
State/province [41] 0 0
Katowice
Country [42] 0 0
Poland
State/province [42] 0 0
Konskie
Country [43] 0 0
Poland
State/province [43] 0 0
Krakow
Country [44] 0 0
Poland
State/province [44] 0 0
Poznan
Country [45] 0 0
Switzerland
State/province [45] 0 0
Vlaud
Country [46] 0 0
Switzerland
State/province [46] 0 0
Fribourg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ardea Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01510769
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris Storgard, MD
Address 0 0
Ardea Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries