A Randomized Controlled Trial Investigating Tailored Treatment With Infliximab for Active Luminal Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 12
- 主要终点
- Level of remission
研究概览
简要总结
To investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab) trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with 'standard of care' IFX treatment and its effects on clinical and endoscopic outcomes.
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
- Double (Participant, Investigator)
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
- •Age > 18 years
- •Active CD (CDAI>220) and signs of active inflammation as evidenced by elevated serum hsCRP levels (>5 mg/L) and/or elevated fecal calprotectin levels (>250 µg/g) and endoscopically visible ulcers.
- •Patients must be naïve to biologics with indication for starting anti-TNF therapy in accordance with national reimbursement criteria.
- •Patients must be naïve to thiopurines or have failed therapy with thiopurines (in which case AZA will be continued).
- •Ongoing steroids are allowed if at stable dose for at least 2 weeks and at a maximum of prednisone 40 mg/d or budesonide 9 mg/day.
- •Patients who consent to receiving Infliximab 5 mg/kg at week 0, 2 and 6 and further on every 8 weeks in conjunction with azathioprine (2,5 mg/kg/day). Patients who develop AZA intolerance during the trial are continued in the trial without AZA (ie IFX monotherapy).
排除标准
- •Absence of endoscopically visible ulcers
- •Prior exposure to infliximab (other biologics allowed)
- •Ongoing steroid therapy at doses > 40 mg/d prednisolone equivalent
- •Previous intolerance to azathioprine leading to drug discontinuation
- •Ongoing infections
- •Positive tuberculosis screen per local guidelines
- •Serious other diseases including cancer in the 5 years prior to inclusion excluding non-melanoma skin cancer
- •Indication for immediate surgery
- •Pregnant or breast-feeding woman.
- •Positive fecal culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools
- •Active tuberculosis
- •Untreated latent tuberculosis (see national recommendations. Appendix 2).
- •Non-compliant subjects.
- •Participation in another therapeutic study.
研究组 & 干预措施
Cohort 1 =Control Group
the dose of IFX will be increased by 5 mg/kg (maximally 1 time) based on symptom relapse (usual clinical practice) Dose will be kept stable ofr the rest of the trial Dose decreases will not be allowed.
干预措施: Infliximab (Drug)
Cohort 2
Dose of IFX will be increased by 2.5 mg/kg (maximally 2 times) if the following criteria are met A dose increase is maintained for the following infusions
干预措施: Infliximab (Drug)
Cohort 3
Dose of IFX will be increased by 5 mg/kg (maximally 1 time) if the following criteria are met A dose increase is maintained for the following infusions
干预措施: Infliximab (Drug)
结局指标
主要结局
Level of remission
时间窗: 54 weeks after Inclusion
Proportion of patients with steroid-free remission (CDAI \< 150) and endoscopic healing (absence of ulcers) at week 54 CDAI = Crohn's Disease Activity Index
次要结局
- Clinical remission(week 14 after inclusion)
- Endoscopic evaluation(week 0, week 12 and week 54)