Biologics, Efficacy, Self, Mesalazine, Ulcerative Colitis
Conditions
Keywords
ulcerative colitis, biologics, mesalazine
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.
Interventions
DRUGInfliximab
Infliximab, 5mg/kg at week 0,2,6 and schedule administration at every 8 weeks
DRUGVedolizumab
Vedolizumab, 300mg at week 0,2,6 and schedule administration at every 8 weeks
DRUGMesalazine
Mesalazine, 4-6g/d, systemic and/or topical administration
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endoscopic remission rate at 12 months | 12 months after first intervention administration | endoscopic remission rate at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| normalization rate of serum biomarker at 12 months | 12 months after first intervention administration | normalization rate of serum biomarker at 12 months |
| normalization rate of serum biomarker at 6 months | 6 months after first intervention administration | normalization rate of serum biomarker at 6 months |
| clinical remission rate at 12 months | 12 months after first intervention administration | clinical remission rate at 12 months |
| clinical remission rate at 6 months | 6 months after first intervention administration | clinical remission rate at 6 months |
| clinical response rate at 12 months | 12 months after first intervention administration | clinical response rate at 12 months |
| clinical response rate at 6 months | 6 months after first intervention administration | clinical response rate at 6 months |
| endoscopic remission rate at 6 months | 6 months after first intervention administration | endoscopic remission rate at 6 months |
| endoscopic response rate at 12 months | 12 months after first intervention administration | endoscopic response rate at 12 months |
| endoscopic response rate at 6 months | 6 months after first intervention administration | endoscopic response rate at 6 months |
| life quality changes at 12 months | 12 months after first intervention administration | life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 12 months |
| life quality changes at 6 months | 6 months after first intervention administration | life quality evaluated by IBDQ (inflammatory bowel disease questionnaire) at 6 months |
Countries
China
Outcome results
None listed