NL-OMON52654招募中4 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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 64（—）
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 (FC) results in the target range (i.e.
- •<250 µg/g for CD patients; <150 µg/g for UC patients) in the previous 6 months
- •NL73966.042.20 / FREE-study (v3.6)
- •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
- •- Absence of symptoms associated with active IBD (judged by the local IBD-team)
- •- Written informed consent granted
排除标准
- •- Perianal fistula
- •- Presence of ileostomy or ileoanal pouch
- •- Any inflammatory comorbidity, such as rheumatoid arthritis
- •- Current treatment with corticosteroids (prednisone or budesonide)
- •- Current pregnancy
研究者
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