NCT02368743已完成不适用
QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score
研究概览
简要总结
This national, observational and multicentre study aims at establishing a picture of real clinical practices management among patients treated with Pentasa®, according to the current therapeutic strategy in proctitis or distal proctosigmoiditis. This study should be able to provide data on patients' health related quality of life, compliance and efficacy in real clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 years or older.
- •Patient suffering from mild to moderate active proctitis or distal proctosigmoiditis (MAYO score ≥ 3 and ≤ 10) at inclusion based on clinical and endoscopic findings within 6 months before study inclusion.
- •Patient with evidence of endoscopic active proctitis or distal proctosigmoiditis (Montreal classification E1 or E2 defined by an involvement not exceeding 25 cm from the anal margin) within 6 months before study inclusion.
- •Treatment of the current flare with Pentasa® to induce a remission initiated by the patient, the general practitioner or the gastroenterologist, during the inclusion visit or during the week before the inclusion visit.
- •Patient having received oral and written information on the study, without any objections for the use of his/her personal data, and having signed a written Informed Consent Form.
排除标准
- •Patient included in an interventional study assessing treatment for active proctitis or distal proctosigmoiditis.
- •Patient with left sided, colitis or pancolitis.
- •Patient with severe proctitis (MAYO score ≥ 11 at inclusion).
- •Patient previously treated with biologics.
- •Patient treated with immunosuppressive within 1 month before study inclusion.
- •Patient treated with corticosteroids within 2 weeks before study inclusion.
研究组 & 干预措施
mesalazine
Treatment according to standard clinical practice.
干预措施: mesalazine (Drug)
结局指标
主要结局
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score
时间窗: From baseline to week 8
次要结局
未报告次要终点
研究者
研究点 (1)
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