EUCTR2011-003768-55-ES进行中（未招募）1 期
A Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety ofLesinurad and Febuxostat Compared to Febuxostat Alone at LoweringSerum Uric Acid and Resolving Tophi in Subjects with TophaceousGout - Combination Treatment Study in Subjects with Tophaceous Gout With Lesinurad and Febuxostat (CRYSTAL)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 324
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 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:
- •a.subjects who are not currently taking an approved ULT must have an sUA value of > or = 10 mg/dL.
- •b.subjects entering the study on febuxostat 40 mg or allopurinol > or = 300 mg and < 600 mg daily (> or = 200 mg daily is allowed for subjects with moderate renal impairment - estimated creatinine clearance > or = 30 and < 60 mL/min) must have an sUA value of > or = 8.0 mg/dL.
- •c.subjects entering the study on febuxostat > or = 80 mg or allopurinol ? 600 mg daily must have an sUA value of > or = 6.0 mg/dL.
- •Subject must be able to take gout flare prophylaxis with colchicine or NSAID (including Cox-2 selective NSAID) ± PPI.
- •Subject with at least 1 measurable tophus on the hands/wrists and/or feet/ankles > or = 5 mm and < or = 20 mm in the longest diameter.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 295
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •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 (NYHA) class III or IV heart failure, myocardial infarction, stroke, or deep venous 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.
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