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

NCT05205603 | Completed Phase 4

• 1 other identifier: 2021ZSLYEC-456
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 11

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.

Conditions

Efficacy, Self; Biologics; Mesalazine; Ulcerative Colitis

Keywords

ulcerative colitis; biologics; mesalazine

Outcome Measures

Primary Outcomes (1)

• endoscopic remission rate at 12 months

  endoscopic remission rate at 12 months

  12 months after first intervention administration

Secondary Outcomes (11)

• normalization rate of serum biomarker at 12 months

  12 months after first intervention administration

• normalization rate of serum biomarker at 6 months

  6 months after first intervention administration

• clinical remission rate at 12 months

  12 months after first intervention administration

• clinical remission rate at 6 months

  6 months after first intervention administration

• clinical response rate at 12 months

  12 months after first intervention administration

Study Arms (2)

Biologics group

PLACEBO COMPARATOR

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; Drug: Vedolizumab

5-ASA group

EXPERIMENTAL

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; Drug: Vedolizumab; Drug: Mesalazine

Interventions

Infliximab DRUG

Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks

5-ASA group; Biologics group

Vedolizumab DRUG

Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks

5-ASA group; Biologics group

Mesalazine DRUG

Mesalazine, 4-6g/d, systemic and/or topical administration

5-ASA group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (11)

People's Hospital of Chongqing

Chongqing, Chongqing Municipality, China

Location

the Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 501655, China

Location

First People's Hospital of Foshan

Guangzhou, Guangdong, China

Location

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

Location

Nanhai Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

Shunde Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Location

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

Shengjing Hospital

Shenyang, Liaoning, China

Location

General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Location

Zhejiang University

Hanzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Infliximab; vedolizumab; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 25, 2022
• Study Start: January 15, 2022
• Primary Completion: January 15, 2024
• Study Completion: January 15, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CN (11)