Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 438
- 试验地点
- 11
- 主要终点
- endoscopic remission rate at 12 months
研究概览
简要总结
Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis. The role of 5-ASA in promoting a higher rate of endocsopic remission is unclear. We aim to evaluate the efficacy of combination of 5-ASA and biologics in treating ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate and severe ulcerative colitis;
- •Subjects were above 18 years old and below 80 years;
- •Indications of 5-ASA or biological treatment;
- •According to the clinical symptoms, ulcerative colitis was diagnosed by endoscopic changes, pathological manifestations. The disease activity of UC was assessed according to the modified Mayo scoring system (modified Mayo: 6~12 for patients with moderate to severe ulcerative colitis);
- •If the subject is a woman, a pregnancy test at baseline is needed to exclude pregnancy. Female patients must follow the contraceptive recommendations of the project;
- •Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
排除标准
- •No indications of 5-ASA or biological treatment;
- •ulcerative colitis patients who had previously undergone a partial colectomy;
- •Patients who are unable to use 5-ASA for a long time;
- •Patients with severe, progressive, or uncontrolled kidney, liver, blood, or endocrine diseases or symptoms;
- •Presence of infected persons, Patients with a contraindication to the use of biological agents such as C. difficile infection or other intestinal pathogens, active tuberculosis or intestinal tuberculosis infection, human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C (defined as: ① HBV: hepatitis B surface antigen (HBs Ag) positive (+), Or patients with positive for hepatitis B core antibody (HBcAb) and the qualitative test results of HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) meet the detection criteria; ② HCV: Any patient with an anti-HCV antibody (HCV Ab) -positive patient with a detectable HCV ribonucleic acid (RNA);
- •Patients with a history of gastrointestinal dysplasia, or dysplasia on any biopsy performed on endoscopy, excluding low-grade dysplasia lesions; known history of lymphoproliferative disease (including lymphoma), or signs and symptoms (e. g., lymphadenopathy and / or splenomegaly); patients with current or previous malignancy;
- •Has been involved in other clinical studies.
研究组 & 干预措施
Biologics group
Biologics including infliximab and vedolizumab. infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.
vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.
干预措施: Infliximab (Drug)
5-ASA group
5-ASA combined with biologics (including infliximab and vedolizumab). infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.
vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.
mesalazine: at a dose of 4-6g/d systemic or topical therapy
干预措施: Vedolizumab (Drug)
Biologics group
Biologics including infliximab and vedolizumab. infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.
vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.
干预措施: Vedolizumab (Drug)
5-ASA group
5-ASA combined with biologics (including infliximab and vedolizumab). infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.
vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.
mesalazine: at a dose of 4-6g/d systemic or topical therapy
干预措施: Infliximab (Drug)
5-ASA group
5-ASA combined with biologics (including infliximab and vedolizumab). infliximab: 5mg/kg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 5mg/kg every 8 weeks.
vedolizumab: 300mg, intravenously administration at week 0, 2, and 6 as induction therapy; subsequently by maintenance therapy at a dose of 300mg every 8 weeks.
mesalazine: at a dose of 4-6g/d systemic or topical therapy
干预措施: Mesalazine (Drug)
结局指标
主要结局
endoscopic remission rate at 12 months
时间窗: 12 months after first intervention administration
endoscopic remission rate at 12 months
次要结局
- clinical remission rate at 12 months(12 months after first intervention administration)
- endoscopic remission rate at 6 months(6 months after first intervention administration)
- clinical response rate at 12 months(12 months after first intervention administration)
- normalization rate of serum biomarker at 6 months(6 months after first intervention administration)
- normalization rate of serum biomarker at 12 months(12 months after first intervention administration)
- clinical remission rate at 6 months(6 months after first intervention administration)
- endoscopic response rate at 12 months(12 months after first intervention administration)
- clinical response rate at 6 months(6 months after first intervention administration)
- endoscopic response rate at 6 months(6 months after first intervention administration)
- life quality changes at 12 months(12 months after first intervention administration)
- life quality changes at 6 months(6 months after first intervention administration)