EUCTR2014-005567-33-NL进行中（未招募）1 期
The Effect of Intensive Urate Lowering Therapy (ULT) with Febuxostat in Comparison with Allopurinol on Cardiovascular Risk in Patients with Gout Using Surrogate Markers: a Randomized, Controlled Trial (Acronym: the FORWARD Trial) - FORWARD trial
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 196
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
- •1. Male or female patients 18 years and older;
- •2. History of gout, flare free in the 4 weeks prior to study entry
- •3. History of crystal (joint liquid) proven diagnosis or anamnestic diagnosis of gout according to Wallace et al. To be eligible a subjects has to present at least 6 out of the twelve clinical, laboratory, and X-ray phenomena listed below:
- •1. Maximum inflammation developed
- •within 1 day
- •2. More than one attack of acute arthritis
- •3. Monoarticular arthritis attack
- •4. Redness observed over joints
- •5. First metatarsophalangeal (MTP) pain or
- •6. Unilateral first MTP joint attack
- •7. Unilateral tarsal joint attack
- •8. Suspected or proven tophus
- •9. Hyperuricemia
- •10. Asymmetric swelling within a joint on
- •11. Subcortical cysts without erosions on
- •12. Negative organisms on culture of joint
- •4. Naive to ULT or previously treated with ULT, but with no ULT treatment in the last 1 month prior to study entry and only if reason for ULT interruption was not due to safety concerns.
- •5. Patients at study entry have elevated serum urate level> 8 mg/dl.
- •6. Overall CV risk based on the scoring proposed by the Joint Task Force of the European Society of Cardiology and other Societies on cardiovascular disease prevention in clinical practice between 5 and 15% (inclusive) as per protocol appendix 2. Patients with diabetes mellitus type 2 could be included in the study if their CV risk score is calculated as =7%.
- •7. Concomitant medications should be maintained stable during the last 2 weeks before randomization
- •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 122
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Severe chronic renal failure (creatinine clearance < 30 ml/min)
- •2. Hepatic failure
- •3. Active liver disease or hepatic dysfunction, defined as both ALT and AST >2 times the upper limit of normal.
- •4. Diabetes mellitus type1
- •5. Life-threatening co-morbidity or with a significant medical condition and/or conditions that would interfere with the treatment, the safety or the compliance with the protocol
- •6. Diagnosis of, or receiving treatment for malignancy (excluding minor skin cancer) in the previous 5 years
- •7. Patients who have experienced either myocardial infarction or stroke
- •8. Patients with inflammatory based arthritis (e.g.: rheumatoid arthritis, etc.)
- •9. Patients with congestive heart failure, New York Heart Association (NYHA) Class III or IV
- •10. Patients with untreated/uncontrolled thyroid function
- •11. Patients with clinically severe peripheral arterial disease
- •12. Concomitant administration of one of the following: azathioprine, mercaptopurine, theophylline, meclofenamate, sulfinpyrazone, trimethoprim-sulfamethoxazole, cyclophosphamide, benzbromarone, pyrazinamide, captopril and enalapril (for Allopurinol), tegafur, pegloticase and tacrolimus.
- •13. Hypersensitivity to any of the active substance or to any of the excipients
- •14. Any contraindication to febuxostat or allopurinol (with reference to the summary of product characteristics).
- •15. Subject is unable to take either of the protocol-required gout flare prophylactic medications (NSAID or colchicine) due to contraindications or intolerance, e.g. hypersensitivity, active gastric ulcer disease, renal impairment and/or changes in liver enzymes
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