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

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Jan 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of combining two types of treatments—mesalazine, a medication often used for ulcerative colitis, and biologics, which are special medications that help reduce inflammation. The goal is to see if this combination can help more patients with moderate to severe ulcerative colitis achieve remission, meaning their symptoms improve significantly and they feel better.

To join the study, participants need to be adults aged 18 to 80 who have been diagnosed with moderate to severe ulcerative colitis and are eligible for either mesalazine or biologic treatment. Women in the study will need to take a pregnancy test to ensure they are not pregnant. Participants can expect regular check-ups and assessments to monitor their health throughout the trial. This study is currently recruiting, and it aims to provide new insights into how these treatments can work together to help manage ulcerative colitis more effectively.

Gender

ALL

Eligibility 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.