Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis
- Conditions
- Ulcerative ColitisEfficacy, SelfBiologicsMesalazine
- Interventions
- Registration Number
- NCT05205603
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 438
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biologics group Infliximab 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. 5-ASA group Mesalazine 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 Biologics group Vedolizumab 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. 5-ASA group Infliximab 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 5-ASA group Vedolizumab 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
- Primary Outcome Measures
Name Time Method endoscopic remission rate at 12 months 12 months after first intervention administration endoscopic remission rate at 12 months
- Secondary Outcome Measures
Name Time Method clinical remission rate at 12 months 12 months after first intervention administration clinical remission rate at 12 months
endoscopic remission rate at 6 months 6 months after first intervention administration endoscopic remission rate at 6 months
clinical response rate at 12 months 12 months after first intervention administration clinical response rate at 12 months
normalization rate of serum biomarker at 6 months 6 months after first intervention administration normalization rate of serum biomarker at 6 months
normalization rate of serum biomarker at 12 months 12 months after first intervention administration normalization rate of serum biomarker at 12 months
clinical remission rate at 6 months 6 months after first intervention administration clinical remission rate at 6 months
endoscopic response rate at 12 months 12 months after first intervention administration endoscopic response rate at 12 months
clinical response rate at 6 months 6 months after first intervention administration clinical response rate at 6 months
endoscopic response rate at 6 months 6 months after first intervention administration endoscopic response rate at 6 months
life quality changes at 6 months 6 months after first intervention administration life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 6 months
life quality changes at 12 months 12 months after first intervention administration life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 12 months
Trial Locations
- Locations (11)
People's Hospital of Chongqing
🇨🇳Chongqing, Chongqing, China
Shunde Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Shengjing Hospital
🇨🇳Shenyang, Liaoning, China
the Sixth Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Guangzhou Panyu Central Hospital
🇨🇳Guangzhou, Guangdong, China
First People's Hospital of Foshan
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Zhejiang University
🇨🇳Hanzhou, Zhejiang, China
General Hospital of Tianjin Medical University
🇨🇳Tianjin, Tianjin, China
Nanhai Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China