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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205603
• Other study ID #: 2021ZSLYEC-456
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2022
• Est. completion date: January 15, 2025

Study information

• Verified date: October 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Min Zhi
• Phone: 13825086505
• Email: zhimin[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 438
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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: ? 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; ? 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.

Related Conditions & MeSH terms

• Biologics
• Colitis
• Colitis, Ulcerative
• Efficacy, Self
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Infliximab
Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks
• Vedolizumab
Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks
• Mesalazine
Mesalazine, 4-6g/d, systemic and/or topical administration

Locations

Country	Name	City	State
China	People's Hospital of Chongqing	Chongqing	Chongqing
China	The Second Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
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	Guangzhou	Guangdong
China	the Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Zhejiang University	Hanzhou	Zhejiang
China	First Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	Shengjing Hospital	Shenyang	Liaoning
China	General Hospital of Tianjin Medical University	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endoscopic remission rate at 12 months	endoscopic remission rate at 12 months	12 months after first intervention administration
Secondary	normalization rate of serum biomarker at 12 months	normalization rate of serum biomarker at 12 months	12 months after first intervention administration
Secondary	normalization rate of serum biomarker at 6 months	normalization rate of serum biomarker at 6 months	6 months after first intervention administration
Secondary	clinical remission rate at 12 months	clinical remission rate at 12 months	12 months after first intervention administration
Secondary	clinical remission rate at 6 months	clinical remission rate at 6 months	6 months after first intervention administration
Secondary	clinical response rate at 12 months	clinical response rate at 12 months	12 months after first intervention administration
Secondary	clinical response rate at 6 months	clinical response rate at 6 months	6 months after first intervention administration
Secondary	endoscopic remission rate at 6 months	endoscopic remission rate at 6 months	6 months after first intervention administration
Secondary	endoscopic response rate at 12 months	endoscopic response rate at 12 months	12 months after first intervention administration
Secondary	endoscopic response rate at 6 months	endoscopic response rate at 6 months	6 months after first intervention administration
Secondary	life quality changes at 12 months	life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 12 months	12 months after first intervention administration
Secondary	life quality changes at 6 months	life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 6 months	6 months after first intervention administration