EUCTR2020-001811-26-BE进行中（未招募）1 期
De-escalation of anti-TNF therapy in adolescents and young adults with IBD with tight faecal calprotectin and trough level monitoring - FREE-study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 148
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
- •- Aged 12-25 years
- •- Diagnosed with luminal Crohn’s disease or ulcerative colitis
- •- Treated with either 8-weekly infliximab or 2-weekly adalimumab
- •- Current anti-TNF agent as first ever anti-TNF agent or prior anti-TNF agent discontinued for reason other than primary non-response or secondary loss-of-response
- •- No previous attempts to lengthen the dosing interval
- •- Three consecutive faecal calprotectin results in the target range (i.e. <250 µg/g for CD patients; <150 µg/g for UC patients) in the previous 6 months or confirmed endoscopic remission within 2 months before study entry (i.e. simple endoscopic score for Crohn’s disease (SES-CD) <3 points; ulcerative colitis endoscopic index of severity (UCEIS) =1 point or Mayo endoscopic subscore =1 point)
- •- Absence of symptoms associated with active IBD (judged by the local IBD-team)
- •- Writeen informed consent granted
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 48
- •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
- •- Perianal fistula
- •- Presence of ileostomy or ileoanal pouch (as FC cut-off is not validated for small bowel faeces)
- •- Any inflammatory comorbidity, such as rheumatoid arthritis
- •- Current treatment with corticosteroids (prednisone or budesonide)
- •- Current pregnancy
研究者
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