Use of Combined Measurements of Serum Infliximab and Anti-infliximab Antibodies in the Treatment of Patients With Crohns Disease Failing Infliximab Therapy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- Proportion of patients with response at week 12, i.e. CDAI decrease of 70 or more for patients with luminal disease, or reduction of 50 percent or more from base line in the number of draining fistulas for patients with fistulising disease.
研究概览
简要总结
To compare treatment outcome in patients with Crohn's disease with secondary loss of response to infliximab (i.e. initial good response follow by loss of response) treated according to current standards based only on clinical features versus treatment based on serum levels of infliximab and anti-infliximab antibody (Ab) status.
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
- Single (Participant)
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
- •Patient must be able to understand the information given to him/her and give written informed consent.
- •Definitive diagnosis of Crohn's disease (confirmed by recent radiological, endoscopic and/or histological evidence according to international criteria) .
- •Age minimum 18 years.
- •Previous good response to at least 3 doses (5mg/kg) of infliximab (as judged by the treating physician).
- •Loss of response to standard doses of infliximab (as judged by the treating physician).
- •Last infliximab infusion given at least 4 weeks before inclusion.
- •For patients with luminal disease, the CDAI should be above 220 points at inclusion.
- •For patients with fistulising disease only, at least one draining perianal fistula (confirmed by radiography, MR, ultrasound or physical examination) should be present.
排除标准
- •Any contraindication to continued infliximab treatment
- •Short bowel syndrome
- •Bowel resection within 12 weeks of inclusion.
- •Current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
- •History of alcohol or drug abuse within the prior year
- •Patients who do not meet concomitant medication criteria.
- •Any other condition, which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
结局指标
主要结局
Proportion of patients with response at week 12, i.e. CDAI decrease of 70 or more for patients with luminal disease, or reduction of 50 percent or more from base line in the number of draining fistulas for patients with fistulising disease.
时间窗: 12 weeks
Clinical response rates at week 12 should be non-inferior in the intervention group as compared to the control group. Both primary end-points should be met in order to declare the primary end-points succesfully archived.
Total expenses related to Crohn's disease during the study (inclusion to week 12).
时间窗: 12 weeks
Crohn related expenses at week 12 should be less in the intervention group as compared to the control group. Both primary end-points should be met in order to declare the primary end-points succesfully archived.
次要结局
- Mean change compared to baseline in WPAI score at week 12.(12 weeks)
- Mean change compared to baseline in IBDQ score at week 12.(12 weeks)
- Mean change compared to baseline in CDAI score at week 4,8, 12,20.(4, 8, 12, 20 weeks)
- Mean change compared to baseline in PDAI score at week 4, 8, 12, and 20.(4, 8, 12, 20 weeks)
- Clinical response at week 4, 8, 20(Week 4, 8, 20)
- Laboratory parameters(Week 12)
- Days with subjective feeling of disability due to Crohn's disease(week 12)
- Serious adverse drug reactions(week 12)
- Expenses related to Crohn's diseae at week 20(week 20)
- Expenses related to Crohn's disease compared to change in CDAI-score (luminal disease) or PDAI-score (fistulizing disease), and IBD-score at week 12 and 20(week 12 and 20)