JPRN-UMIN000034016已完成未知
The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study - STABILITY study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 84
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
- 16years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1: The patients who are intolerant for mesalazine 2: The patients who were seemed to perform remission maintenance therapy by mesalazine enema at least 2 times per week during 48 weeks with stability 3: The patients who are difficult to perform 2 times total colonoscopy at the achievement of remission induction by budesonide form enema and week 48 4: The patients who are treated with only budesonide form enema at the randomization 5: The patients who had history of treatment with biologics or JAK inhibitor. However, the patients who were administrated with stable dose more than 6 months or withdrawn more than 4 months before can be enrolled. 6: The patients who were changed the dosage of concomitant immunomodulator within 3 months prior to registration 7: The patients who were changed the dosage of concomitant 5-aminosalicylate within 4 weeks prior to registration 8: The patients who were administrated steroid except budesonide form enema within 4 weeks prior to registration 9: The patients who are treated with topical 5-aminosalicylate (enema or suppository) at the registration. However, the patients who were withdrawn for the topical 5-aminosalicylate (enema or suppository) at the registration can be enrolled. 10: The patients who were indicated the lesion (1 or more than 1 of Mayo endoscopic subscore) at the proximal to splenic flexure by total colonoscopy after remission induction by budesonide form enema. 11: The patients who are treated with cytapheresis 12: The patients who were judged as unsuitable participant for registration of this study by physician
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