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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis; Efficacy, Self; Biologics; Mesalazine
• Intervention / Treatment: Drug: Infliximab; Drug: Vedolizumab; Drug: Mesalazine

• Study Type: Interventional
• Enrollment (Actual): 438
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • People's Hospital of Chongqing
  • Guangdong
    • Guangzhou, Guangdong, China, 501655
      • The sixth affiliated hospital of Sun Yat-Sen University
    • Guangzhou, Guangdong, China
      • First People's Hospital of Foshan
    • Guangzhou, Guangdong, China
      • Guangzhou Panyu Central Hospital
    • Guangzhou, Guangdong, China
      • Nanhai Hospital, Southern Medical University
    • Guangzhou, Guangdong, China
      • Shunde Hospital of Southern Medical University
    • Shantou, Guangdong, China
      • First Affiliated Hospital of Shantou University Medical College
  • Liaoning
    • Dalian, Liaoning, China
      • The Second Affiliated Hospital of Dalian Medical University
    • Shenyang, Liaoning, China
      • Shengjing Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • General Hospital of Tianjin Medical University
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with moderate and severe ulcerative colitis;
2. Subjects were above 18 years old and below 80 years;
3. Indications of 5-ASA or biological treatment;
4. 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);
5. 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;
6. Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion Criteria:

1. No indications of 5-ASA or biological treatment;
2. ulcerative colitis patients who had previously undergone a partial colectomy;
3. Patients who are unable to use 5-ASA for a long time;
4. Patients with severe, progressive, or uncontrolled kidney, liver, blood, or endocrine diseases or symptoms;
5. 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);
6. 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;
7. Has been involved in other clinical studies.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
clinical remission rate at 12 months	clinical remission rate at 12 months	12 months after first intervention administration
clinical response rate at 12 months	clinical response rate at 12 months	12 months after first intervention administration
endoscopic response rate at 12 months	endoscopic response rate 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 6 months	clinical remission rate at 6 months	6 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 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

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): January 15, 2024
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ulcerative colitis; biologics; mesalazine
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydroxy Acids; Hydrocarbons, Aromatic; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Phenols; Benzene Derivatives; Acids, Carbocyclic; Aminobenzoates; Benzoates; Salicylates; Hydroxybenzoates; meta-Aminobenzoates; Aminosalicylic Acids; Infliximab; Mesalamine; vedolizumab
• Other Study ID Numbers: 2021ZSLYEC-456

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No