Diacerein Combined With Febuxostat Relieves Symptoms of Gout by Suppressing IL-1βinflammation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Patients'intensity of pain
研究概览
简要总结
The aim of study was to assess the efficiency and safety of oral IL-1βinhibitor in combination with urate lowering therapy on joint pain intensity,urate control, global assessments of disease activity, self-monitored gouty acute flare times, inflammatory markers and symptoms improving related life quantity in gouty patients.
详细描述
This was a randomized single-dose, open-label and active-controlled study which was carried out in 96 primary gout patients. Subjects and doctors have no access to randomization sequence which is determined by the primary investigator.All patients received an open-label febuxostat 40mg daily during the whole study. Healthy control were 32 age-matched men from volunteers in the medical health center.Two primary end points included pain intensity measurement which was recorded at each visit and subsequently acute flare times which was recorded at home and reported to investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants who were allocated to the study all had a history of taking tolerable and adequate dose of urate lowering therapy including febuxostat 40-80mg daily or allopurinol 200-300 mg daily for at least 4 weeks and were defined as difficult to treat or refractory gout patients. All patients had a negative of rheumatoid factor and antinuclear antibody, Hb>100g/L, total leukocyte count≥3.5×109, PLT≥80×109, serum creatinine<133umol/L, transaminases<60U/L and fasting urate≥6.0mg/dL.
- •Inclusion criteria for the gouty patients were age≥18 years old, BMI(18-30kg/m2). All participants enrolled in our study fulfilled American College of Rheumatology criteria for primary gout.
排除标准
- •Exclusion criteria included secondary gout (because it is always associated with some underlying renal disease), a history of congestive heart failure, serum creatinine≥133umol/L (because the patients have underlying risks if NSAID needed) or the use of glucocorticoid>15mg daily,colchicine, uricosuric drugs, chemotherapy or immunosuppressive therapy in the past three months.
研究组 & 干预措施
Febuxostat
Febuxostat 40mg once a day
干预措施: Febuxostat (Drug)
Febuxostat plus diacerein
Febuxostat 40mg once a day plus diacerein 50mg twice a day
干预措施: Diacerein (Drug)
Febuxostat plus diacerein
Febuxostat 40mg once a day plus diacerein 50mg twice a day
干预措施: Febuxostat (Drug)
Febuxostat plus Colchicine
Febuxostat 40mg once a day plus Colchicine 0.5mg twice a day
干预措施: Colchicine (Drug)
Febuxostat plus Colchicine
Febuxostat 40mg once a day plus Colchicine 0.5mg twice a day
干预措施: Febuxostat (Drug)
结局指标
主要结局
Patients'intensity of pain
时间窗: 12 weeks
Patients' intensity of pain was assessed at each visit by a single question using a 100mm visual analogue scale (VAS). The pain question was how much pains have you had because of your illness in the past seven days? The two anchors were no pain (0 score) and unbearable pain (score of 100). Patients were instructed to draw a vertical mark on the scaleline and the investigator measured the length and recorded the result.
Acute gout flare times
时间窗: 24 weeks
Acute gout flare was defined by pain, redness, swelling, and warmth on joints or adjacent soft tissue and pain VAS more than 3.0. For subsequent gout flares, subjects were recorded events by themselves and were reported to investigator whether they had any new or recurrent gout flares since their last visit
次要结局
- HAQ(12 weeks)
- Flow Cytometry analysis on cell markers(12 weeks)
- Quantitative PCR for mRNA expression of inflammatory cytokines on PBMC(12 weeks)
- Serum concentration of inflammatory cytokines(12 weeks)
- Serum and urine urate concentration(24 weeks)