EUCTR2016-002707-25-IT进行中（未招募）1 期
Comparison between two therapeutic strategies for the maintenance of clinical and endoscopic remission in patients with ulcerative colitis treated by infliximab (SCILLA). - n.a.
IRCCS ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 100 人开始时间: 2021年1月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age 18 -65 years
- •- Written informed consent and willing to adhere to study procedures.
- •- Therapy with infliximab since at least 12 months, with one infusion every 8 weeks (, according to the summary of product characteristics)
- •- Sustained steroid-free remission in the last 6 months prior to inclusion, except for use of steroids as a preventive measure for infliximab infusion reaction, if required by local guidelines.
- •- Global Mayo score at baseline = 2
- •- All Mayo subscores = 1
- •- Absence of rectal bleeding
- •- Effective methods to avoid pregnancy during the study period
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Disabling and persisting extraintestinal manifestation at baseline
- •- Patients unable to comply with study procedures
- •- Known intolerance or previous allergic reaction to
- •thiopurines
- •- Concomitant therapy with allopurinol
- •- Any disease not compatible with the use of infliximab or azathioprine, as per clinician’s judgement.
- •- Need for dose escalation of infliximab in the last 12
- •months prior to baseline.
- •- White blood cell count < 3000/mmc or absolute clinically relevant lymphopenia at baseline
- •- Active pregnancy or breastfeeding, willing for pregnancy during the study period.
研究者
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