Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients
NCT ID: NCT02063997
Last Updated: 2018-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
248 participants
INTERVENTIONAL
2014-03-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arhalofenate 600 mg
Arhalofenate 600 mg
Arhalofenate 600 mg tablets once daily for 12 weeks
Arhalofenate 800 mg
Arhalofenate 800 mg
Arhalofenate 800 mg tablets once daily for 12 weeks
Allopurinol 300 mg; colchicine 0.6 mg
Allopurinol 300 mg
Allopurinol 300 mg tablets once daily for 12 weeks
Colchicine 0.6 mg
Colchicine 0.6 mg over-encapsulated tablets once daily for 12 weeks
Allopurinol 300 mg
Allopurinol 300 mg
Allopurinol 300 mg tablets once daily for 12 weeks
Placebo
Placebo
Placebo tablets once daily for 12 weeks
Interventions
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Arhalofenate 600 mg
Arhalofenate 600 mg tablets once daily for 12 weeks
Allopurinol 300 mg
Allopurinol 300 mg tablets once daily for 12 weeks
Colchicine 0.6 mg
Colchicine 0.6 mg over-encapsulated tablets once daily for 12 weeks
Placebo
Placebo tablets once daily for 12 weeks
Arhalofenate 800 mg
Arhalofenate 800 mg tablets once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Known gout diagnosis (per criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout, see Appendix 3)
* At least three patient-reported and documented flares during the 12 months prior to screening (the first of these flares may have resulted in the gout diagnosis; any recent flare must have resolved, with the patient back to usual comfort level at least seven days prior to screening)
* Have not used any ULT since at least two weeks prior to screening
* Have not used colchicine since at least two weeks prior to screening
* Usual level of resting pain when NOT experiencing flare is three or less on an 11-point numerical rating scale (NRS)
* Have a sUA ≥ 7.5 mg/dL and ≤ 12 mg/dL at screening
* All female patients must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses for at least two years); or have a partner who has undergone vasectomy or must agree to use two medically accepted methods of contraception including a barrier method (see Appendix 4) for the entire duration of study participation unless she reports complete sexual abstinence. Female patients must not be pregnant or lactating
* Estimated creatinine clearance (eCrCl) ≥ 60 ml/min/1.73m2 calculated by Cockcroft-Gault method at screening
* Liver function tests ≤ 3X ULN for AST, ALT and total bilirubin; ≤ 3X ULN for ALP and GGT; and ≤ 3X ULN for CK at screening
* All other clinical laboratory parameters must be within normal limits or considered not clinically significant
* Electrocardiogram (ECG) must be normal, or if abnormal, considered not clinically significant at screening
* Systolic blood pressure ≤ 160 mm Hg and diastolic blood pressure ≤ 90 mm Hg at screening; known hypertensive patients stable (blood pressure \[BP\] reading as above) with medication may be included
* Patients using agents known to influence sUA levels (see Appendix 7) must be on a stable dose and regimen for at least two weeks prior to screening and must be willing to continue the same doses and regimens during study participation
* Expected to be able to tolerate a short course of either oral NSAIDs and/or oral steroids as may be needed to treat a flare
* Must be able to swallow tablets/capsules
* Following training, must be willing and able to understand and complete an electronic diary
Exclusion Criteria
* Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder or organ transplant)
* Diagnosis of xanthinuria
* Fractional excretion of urate \> 10% at screening
* History of documented or suspected kidney stones
* Known infection with the human immunodeficiency virus (HIV) or history of viral hepatitis type B or C
* A diagnosis of illicit drug or alcohol dependence or abuse within one year of screening
* History of upper gastrointestinal (GI) bleeding, documented peptic ulcer disease (unless known H. pylori infection treated successfully without recurrence), within three years of screening
* History of stroke, transient ischemic attack (TIA), acute myocardial infarction (MI), congestive heart failure (NYHA Class II-IV), angina pectoris, coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization), lower extremity bypass procedure, systemic or intracoronary fibrinolytic therapy within five years of screening
* History of cancer within five years of screening, with the following exceptions: adequately treated non-melanomatous skin cancers, non-metastatic prostate cancer or in situ cervical cancer
* Patients with a history of bladder cancer, active bladder cancer or hematuria
* Body mass index (BMI) \> 42 kg/m2 at screening
* Current or expected requirement for anticoagulant therapy (except for aspirin ≤ 325 mg/day, clopidogrel \[Plavix\] ≤ 75 mg/day, or prasugrel \[Effient\] ≤ 10 mg/day)
* Use of any of the following within eight weeks prior to screening: potent CYP3A4 inhibitors, cytotoxic agents (including azathioprine, mercaptopurine, cyclosporine, cyclophosphamide, etc.), ranolazine, digoxin, theophylline, sulphonylureas, thiazolidinediones (e.g., rosiglitazone or pioglitazone), atypical antipsychotic agents, ampicillin, amoxicillin, loop diuretics or phenytoin
* Chronic treatment with NSAIDs (except for as needed \[prn\] use to treat acute events); per protocol a short course of oral NSAIDs may be used to treat flares during the study
* Current or expected chronic treatment with systemic corticosteroids (topical, ophthalmic, intra-articular or inhaled corticosteroid at a dose \< 1600 μg/day is permitted); per protocol a short course of oral corticosteroid may be used to treat flares occurring during the study
* History of intra-articular steroid injection to treat flare within four weeks of screening
* Known hypersensitivity or intolerance to allopurinol or colchicine
* Treatment with any other investigational therapy within 30 days or within five half lives, whichever is longer, prior to screening
* Patients who received arhalofenate in a previous trial
* Any other condition(s) that would compromise the safety of the patient, prevent compliance with the study protocol including ability to use an electronic diary, or compromise the quality of the clinical study, as judged by the Investigator and/or Medical Monitor
18 Years
75 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
El Cajon, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
DeLand, Florida, United States
Jupiter, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Brownsburg, Indiana, United States
Bowling Green, Kentucky, United States
Elizabethtown, Kentucky, United States
Louisville, Kentucky, United States
Owensboro, Kentucky, United States
Hagerstown, Maryland, United States
Olive Branch, Mississippi, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Omaha, Nebraska, United States
Brooklyn, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Johnstown, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Greer, South Carolina, United States
Summerville, South Carolina, United States
Bristol, Tennessee, United States
Jackson, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Spokane, Washington, United States
Clarksburg, West Virginia, United States
Newmarket, Ontario, Canada
Sarnia, Ontario, Canada
Toronto, Ontario, Canada
Tbilisi, , Georgia
Countries
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References
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Poiley J, Steinberg AS, Choi YJ, Davis CS, Martin RL, McWherter CA, Boudes PF; Arhalofenate Flare Study Investigators. A Randomized, Double-Blind, Active- and Placebo-Controlled Efficacy and Safety Study of Arhalofenate for Reducing Flare in Patients With Gout. Arthritis Rheumatol. 2016 Aug;68(8):2027-34. doi: 10.1002/art.39684.
Other Identifiers
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CB102-21425
Identifier Type: -
Identifier Source: org_study_id
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