ACTRN12621001498886招募中4 期
Comparison between switching from intravenous to subcutaneous infliximab on the maintenance of clinical and biochemical remission in patients with inflammatory bowel disease
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 176
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •·Diagnosis of ulcerative colitis or Crohn's disease
- •·On IV infliximab treatment – must be on maintenance treatment at 5mg/kg dosing every 8 weeks
- •·Steroids-free clinical remission and/or biochemical remission for at least 12 weeks
- •a.Clinical remission:
- •i. Ulcerative colitis: Partial Mayo Score (pMS) < 2
- •ii. Crohn's disease: Harvey Bradshaw Index (HBI) < 5 points
- •b.Biochemical remission:
- •i. C-reactive protein (CRP) < 5mg/L
- •ii. Faecal calprotectin < 150 µg/mL
排除标准
- •- Age < 18 years
- •- Patients awaiting bowel surgery
- •- Patients with a stoma
- •- Consent not obtained or unable to give informed consent
研究者
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