EUCTR2020-001811-26-NL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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •- Three consecutive faecal calprotectin results in the target range in the previous 6 months or confirmed endoscopic remission within 2 months before study entry
- •- Absence of symptoms associated with active IBD
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •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
- •- Any inflammatory comorbidity, such as rheumatoid arthritis
- •- Current treatment with corticosteroids (prednisone or budesonide)
研究者
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