Overview

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

Status:
Not yet recruiting
Trial end date:
2025-01-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Treatments:
Infliximab
Mesalamine
Vedolizumab
Criteria
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.