Combining Biological Therapies in Patients With Inflammatory Bowel Disease: a Finnish Multi-centre Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Clinical response
研究概览
简要总结
The efficacy and safety of dual biological therapy.
详细描述
Data of all patients treated with the combination of two biologicals in four Finnish tertiary centres were collected and analysed. Inclusion criteria were simultaneous use of two biological treatments (infliximab, adalimumab, golimumab, vedolizumab or ustekinumab), age 16 years or over and follow-up for at least induction period after introduction of second biological therapy. The primary outcome was effectiveness, defined as remission assessed by physician after at least four months of DBT. The secondary outcome was safety defined by any adverse events or infection complications during DBT.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Simultaneous use of two different biological treatments for IBD.
- •Treatment duration with combination therapy for at least for induction period.
排除标准
- •Age under 16 years.
结局指标
主要结局
Clinical response
时间窗: 18 months
In CD, clinical response was assessed using a modified Harvey-Bradshaw index (HBI, omitting abdominal palpation) and clinical remission was defined as HBI\<5. In UC, partial MAYO score \<3 was cut the off value for clinical remission. Patients symptoms were assessed at baseline, 4, 12 and 18 months after initiation of treatment.
次要结局
- Endoscopic response(18 months)
- Haemoglobin level improvement(18 months)
- Treatment related infections(18 months)
- Calprotectin level improvement(18 months)
- C-reactive protein level improvement.(18 months)
研究者
Heli T Eronen
Principal investigator
Tampere University Hospital