NCT00291915Unknown4 期
Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis
Goupe d'Etudes et de Recherche Clinique En Rhumatologie2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2004年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Disease Activity Score
研究概览
简要总结
Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab)
详细描述
Patients: early ( less than 6 months), active ( DAS>5.2),potentially severe ( Leiden score>6) Study design:12 months, prospective , randomized, open Study treatments: Methotrexate at a weekly dose of 0.3mg/kilo alone or in combination with adalimumab 40 mg every the other week Outcome measures: DAS over the 12 months
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Early Active Potentially severe arthritis
排除标准
- •contra indication of methotrexate or anti TNF
结局指标
主要结局
Disease Activity Score
次要结局
- -Radiological score
- -Functional impairment ( HAQ)
- -Pain (VAS)
研究者
研究点 (2)
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