NCT01387698已完成不适用
Observatoire Prospectif, Longitudinal Dans la Prise en Charge Thérapeutique de La Rectocolite Hémorragique légère à Modérée
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 812
- 试验地点
- 80
- 主要终点
- Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
研究概览
简要总结
The primary objective of this study is to confirm the long-term efficacy (remission and maintenance in remission) of current validated treatments. Each patient will be followed during 3 years in this non-interventional trial.
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
- •18 years old or above
- •Ulcerative colitis, whatever the extension, in mild to moderate flare-up (including proctitis)
- •Having received the information sheet
排除标准
- •Participating, at the time of inclusion, in another study using an investigational drug or device
结局指标
主要结局
Remission rate (ulcerative colitis) - calculated by UCCS (Ulcerative Colitis Clinical Score)
时间窗: From baseline (inclusion visit) and at 3 year interval after baseline
次要结局
- Colonoscopy (if available) - assessing endoscopic activity of the ulcerative colitis(From baseline (inclusion visit) to 3 year after baseline)
- Occurence/number of adverse events(From baseline (inclusion visit) to year 3 after baseline)
- Assessing treatment adherence by patient's completion of questionnaire MMAS-8 (Modified Morisky Adherence Scale)(From baseline (inclusion visit) and at 3 year interval after baseline)
- Remission rate (endoscopic) - calculated by UC-DAI (Ulcerative Colitis Disease Activity Index)(From baseline (inclusion visit) and at 3 year interval after baseline)
研究者
研究点 (80)
Loading locations...
相似试验
已完成
不适用
Stroke Team Remote Evaluation Using a Digital Observation Camera- Long Term Outcomes(STRokE DOC-LTO)Telemedicine Evaluation vs Telephone EvaluationNCT00936455University of California, San Diego75
终止
不适用
An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMRKidney Transplant RejectionNCT04711850Hansa Biopharma AB18
招募中
不适用
Long-Term Follow-up ProtocolDystrophic Epidermolysis BullosaRecessive Dystrophic Epidermolysis BullosaDominant Dystrophic Epidermolysis BullosaNCT04917887Krystal Biotech, Inc.50
已完成
不适用
Long-Term Follow Up Study for AMD3100 PatientsMyelomaNCT00476294M.D. Anderson Cancer Center7
已完成
不适用
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral RectopexyRectal ProlapseNCT04130555Meccellis Biotech55