Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bath AS disease activity index (BASDAI)
研究概览
简要总结
To determine the safety and efficacy of switch effects to adalimumab in etanercept-treated AS patients.
详细描述
This single-centre, open-labeled randomized controlled study will evaluate the safety and efficacy of adalimumab in etanercept-treated Ankylosing Spondylitis(AS) patients.
Thirty patients will be enrolled and randomized equally into two arms.
Dosage and Administration：For standard dose(etanercept 50 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously biweekly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously twice a week for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously biweekly for another 8 weeks.For half dose(etanercept 25 mg weekly) treated patients, the treatment arm will receive adalimumab 40 mg subcutaneously monthly for 8 weeks. The control arm will continue etanercept 25 mg subcutaneously weekly for 8 weeks. At week 8, the control arm will be switched to adalimumab 40 mg subcutaneously monthly for another 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AS, as defined by 1984 Modified New York Criteria for AS.
- •Stable background therapy as non-steroid anti-inflammatory for 2 weeks.
- •Stable glucocorticoid for 4 weeks.
- •Stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8 weeks.
- •Stable anti-TNF biologics for 4 weeks.
- •Written informed consent.
排除标准
- •Serum creatinine ≥3.0 mg/dl.
- •GPT≥5 times the laboratory's upper limit of normal.
- •Pregnant or breast-feeding women.
结局指标
主要结局
Bath AS disease activity index (BASDAI)
时间窗: weeks 8
The score of BASDAI on weeks 8
次要结局
未报告次要终点
研究者
GCRC
Etanercept versus Adalimumab in the Treatment of Patients with Ankylosing Spondylitis. A Switch Study.
Chung Shan Medical University