Ulcerative colitis
Conditions
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Meets the diagnostic criteria for UC set out in the *Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (Xi’an, 2023)*; 2.In the active phase of the disease, with a modified Mayo score of >=2; 3.First-time treatment with VDZ, using either VDZ monotherapy or VDZ in combination with 5-ASA, with complete follow-up data and a follow-up period of >=52 weeks; 4.Patients and their families are informed about the treatment plan; 5.Aged 18 or over;
Exclusion criteria
Exclusion criteria: 1.Other intestinal disorders, such as suspected Crohn’s disease, colitis of undetermined aetiology, ischaemic colitis and radiation colitis; 2.Has previously received treatment with other biologics or small-molecule drugs; 3.Concomitant malignant tumours or autoimmune diseases; 4.This treatment regimen includes topical or systemic glucocorticoids; 5.Allergy to VDZ or 5-ASA-type medicines; 6.Discontinuing treatment without authorisation, altering the treatment regimen, or failing to attend follow-up appointments for less than 52 weeks during the course of treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate at 26 weeks;52-week clinical response rate;52-week clinical remission rate;Clinical remission rate at 26 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in IBDQ scores;Changes to the Modified Mayo Score;Changes to SAS Scores;Changes in SDS scores; | — |
Countries
China
Contacts
Public ContactLiu Xinjuan
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed