Combining Mesalazine with Biologics for Ulcerative Colitis Treatment
Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis: a Multicenter, Prospective, Randomized, Controlled Clinical Study
This study is testing if combining Mesalazine with biologic treatments can help adults with moderate to severe ulcerative colitis feel better and achieve better results in their gut health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 438 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | Vedolizumab, infliximab, adalimumab |
| Locations | 11 sites (Chongqing, Chongqing and 10 other locations) |
| Trial ID | NCT05205603 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of combining Mesalazine with biologic therapies such as Infliximab and Vedolizumab in treating patients with moderate to severe ulcerative colitis. The study aims to determine if this combination can improve endoscopic remission rates, which are currently low with biologic treatments alone. Eligible participants are adults diagnosed with moderate to severe ulcerative colitis, and the study will assess their response to the combined treatment approach. The trial is conducted at multiple locations in China, including hospitals in Guangzhou and Chongqing.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with moderate to severe ulcerative colitis who are indicated for 5-ASA or biological treatment.
Not a fit: Patients who have previously undergone a partial colectomy or do not have indications for 5-ASA or biological treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could lead to higher rates of remission for patients suffering from moderate to severe ulcerative colitis.
How similar studies have performed: While biologics have shown effectiveness in treating ulcerative colitis, the combination with Mesalazine is less explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chongqing, Chongqing and 10 other locations
- People's Hospital of Chongqing — Chongqing, Chongqing, China (Not_yet_recruiting)
- the Sixth Affiliated Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
- First People's Hospital of Foshan — Guangzhou, Guangdong, China (Recruiting)
- Guangzhou Panyu Central Hospital — Guangzhou, Guangdong, China (Recruiting)
- Nanhai Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
- Shunde Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
- First Affiliated Hospital of Shantou University Medical College — Shantou, Guangdong, China (Recruiting)
- The Second Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
- Shengjing Hospital — Shenyang, Liaoning, China (Recruiting)
- General Hospital of Tianjin Medical University — Tianjin, Tianjin, China (Recruiting)
- Zhejiang University — Hanzhou, Zhejiang, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Min Zhi
- Email: zhimin@mail.sysu.edu.cn
- Phone: 13825086505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.