Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study

Conditions
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Ulcerative Colitis, Efficacy, Self, Biologics, Mesalazine

Intervention / Treatment
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* Drug: Infliximab
* Drug: Vedolizumab
* Drug: Mesalazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Biologics group<br>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. | Drug: Infliximab<br>* Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks<br>Drug: Vedolizumab<br>* Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks<br>|
| Experimental: 5-ASA group<br>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 | Drug: Infliximab<br>* Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks<br>Drug: Vedolizumab<br>* Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks<br>Drug: Mesalazine<br>* Mesalazine, 4-6g/d, systemic and/or topical administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endoscopic remission rate at 12 months | endoscopic remission rate at 12 months | 12 months after first intervention administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normalization rate of serum biomarker at 12 months | normalization rate of serum biomarker at 12 months | 12 months after first intervention administration | 
| normalization rate of serum biomarker at 6 months | normalization rate of serum biomarker at 6 months | 6 months after first intervention administration | 
| clinical remission rate at 12 months | clinical remission rate at 12 months | 12 months after first intervention administration | 
| clinical remission rate at 6 months | clinical remission rate at 6 months | 6 months after first intervention administration | 
| clinical response rate at 12 months | clinical response rate at 12 months | 12 months after first intervention administration | 
| clinical response rate at 6 months | clinical response rate at 6 months | 6 months after first intervention administration | 
| endoscopic remission rate at 6 months | endoscopic remission rate at 6 months | 6 months after first intervention administration | 
| endoscopic response rate at 12 months | endoscopic response rate at 12 months | 12 months after first intervention administration | 
| endoscopic response rate at 6 months | endoscopic response rate at 6 months | 6 months after first intervention administration | 
| life quality changes at 12 months | life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 12 months | 12 months after first intervention administration | 
| life quality changes at 6 months | life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 6 months | 6 months after first intervention administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcerative colitis, biologics, mesalazine