A Single-Center Observational Study on the Impact of Symptom Assessment Timing on the Short-Term Efficacy of 5-ASA Therapy in Patients With Initial-Onset or Relapsed Mild-to-Moderate Active Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The Endoscopic Remission Rate
研究概览
简要总结
This study aims to collect the relevant clinical examination results of patients during the 5-ASA treatment period through opportunistic sampling of patients with mild to moderate active ulcerative colitis (UC). The study compares the impact of the time nodes of the first assessment (4th, 8th, and 12th weeks) on the short-term efficacy of 5-ASA. By integrating the dynamic changes of symptom scores and related biomarkers, the study clarifies the time trajectory of symptom relief in patients with mild to moderate UC, identifies the characteristics of early responders and non-responders, and further explores the association between baseline clinical features and treatment responses, thereby assisting in individualized treatment decisions.
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the diagnostic criteria of the China's 2023 Consensus Opinion on the Diagnosis and Treatment of Inflammatory Bowel Disease, the disease status is newly diagnosed ulcerative colitis (UC) or mild to moderate active UC with remission followed by recurrence (modified Mayo score 3-10 points);
- •Age: 18-59 years old;
- •The attending physician will propose an oral mesalazine or an oral w/ topical mesalazine combined treatment plan based on the patient's condition;
- •Patients who are abble to and are willing to comply with the research protocol can provide a signed and dated written informed consent form.
排除标准
- •Use any form of hormone within the past 14 days;
- •Have received immunosuppressive therapy within the past 90 days;
- •Have used infliximab, adalimumab, or vedolizumab within the past 60 days;
- •Have taken anti-diarrheal drugs within the past 3 days;
- •Have participated in any clinical trial within the past 3 months;
- •Allergic to mesalazine or salicylic acid preparations (except sulfasalazine), including severe adverse reactions, liver and kidney diseases, heart and lung diseases, malignant tumors, etc.;
- •Have had severe liver and kidney diseases, heart and lung diseases, hematological diseases and pancreatic diseases in the past;
- •Pregnant or lactating women;
- •Patients who have withdrawn their informed consent.
研究组 & 干预措施
4-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks
干预措施: Erythrocyte Sedimentation Rate Test at 4-week (Diagnostic Test)
4-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks
干预措施: 5-ASA (5-Aminosalicylate) (Drug)
4-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks
干预措施: Colon Endoscopy Procedure (Procedure)
4-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks
干预措施: Blood Routine Test at 4-week (Diagnostic Test)
4-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks
干预措施: Stool Routine Test at 4-week (Diagnostic Test)
4-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks
干预措施: C-reactive Protein Test at 4-week (Diagnostic Test)
4-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks
干预措施: Liver Function Test at 4-week (Diagnostic Test)
4-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 4 weeks
干预措施: Kidney Function Test at 4-week (Diagnostic Test)
8-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 8 weeks
干预措施: 5-ASA (5-Aminosalicylate) (Drug)
8-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 8 weeks
干预措施: Colon Endoscopy Procedure (Procedure)
8-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 8 weeks
干预措施: Blood Routine Test at 8-week (Diagnostic Test)
8-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 8 weeks
干预措施: Stool Routine Test at 8-week (Diagnostic Test)
8-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 8 weeks
干预措施: Erythrocyte Sedimentation Rate Test at 8-week (Diagnostic Test)
8-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 8 weeks
干预措施: C-reactive Protein Test at 8-week (Diagnostic Test)
8-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 8 weeks
干预措施: Liver Function Test at 8-week (Diagnostic Test)
8-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 8 weeks
干预措施: Kidney Function Test at 8-week (Diagnostic Test)
12-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 12 weeks
干预措施: 5-ASA (5-Aminosalicylate) (Drug)
12-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 12 weeks
干预措施: Colon Endoscopy Procedure (Procedure)
12-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 12 weeks
干预措施: Blood Routine Test at 12-week (Diagnostic Test)
12-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 12 weeks
干预措施: Stool Routine Test at 12-week (Diagnostic Test)
12-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 12 weeks
干预措施: Erythrocyte Sedimentation Rate Test at 12-week (Diagnostic Test)
12-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 12 weeks
干预措施: C-reactive Protein Test at 12-week (Diagnostic Test)
12-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 12 weeks
干预措施: Liver Function Test at 12-week (Diagnostic Test)
12-week Evaluation of Disease Progression
UC patients with initial onset or recurrence whose assessment time interval is set at 12 weeks
干预措施: Kidney Function Test at 12-week (Diagnostic Test)
结局指标
主要结局
The Endoscopic Remission Rate
时间窗: 48 weeks From Enrollment
The primary outcome measure is the endoscopic remission rate at 48 weeks from enrollment, defined as the proportion of patients achieving a Mayo endoscopic subscore of 0 or 1. Participants are adults (18-59 years) with newly diagnosed or relapsing mild-to-moderate ulcerative colitis (modified Mayo score 3-10) receiving oral or oral-plus-topical mesalazine therapy. Patients with recent use of corticosteroids, immunosuppressants, biologics, or other confounding treatments are excluded. Endoscopic assessment is performed at week 48 to evaluate mucosal healing, and the remission rate is calculated based on the number of patients meeting the endoscopic criteria.
次要结局
- The symptom improvement at 12-week after enrollment(12-week after enrollment)
- The symptom remission at 12-week after enrollment(12-week after enrollment)
- The clinical improvement at 12-week after enrollment(12-week after enrollment)
- The clinical remission at 12-week after enrollment(12-week after enrollment)
研究者
Jie Liang
Professor
Xijing Hospital of Digestive Diseases