A Multicentered Prospective Cohort Study of Chinese IBD Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 30 May 2022
• Main ID: NCT05386290
• Date of registration: 17/05/2022
• Prospective Registration: No
• Primary sponsor: Peking Union Medical College Hospital
• Public title: A Multicentered Prospective Cohort Study of Chinese IBD Patients
• Scientific title: A Multicentered Prospective Cohort Study of Chinese IBD Patients Concerning Cost-effectiveness Analysis, Therapeutic Effect Predictor Exploration and Gut Microbiota Analysis
• Date of first enrolment: July 9, 2020
• Target sample size: 200
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/show/NCT05386290
• Study type: Observational

Countries of recruitment

China

Contacts

• Name: Hong Yang, Doctor
• Affiliation: Peking Union Medical College Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- be diagnosed CD or UC according to Chinese consensus on diagnosis and treatment in
inflammatory bowel disease(2018, Beijing)

- willing to be followed up

- intend to be treated by biological agents (VDZ, IFX or UST) or conventional drugs
(glucocoticoid±immunosupressive drugs±5-ASA)

Exclusion Criteria:

- with complex complications



Age minimum: 14 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Ulcerative Colitis

Intervention(s)

Drug: Infliximab

Drug: Vedolizumab

Drug: Ustekinumab

Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)

Primary Outcome(s)

endoscopic remission rate at week 12 [Time Frame: week 12 after treatment]

Secondary Outcome(s)

clinical remission at week 0, 12 and 52 [Time Frame: week 0, week 12 and week 52 after treatment]

Secondary ID(s)

JS-3086

Source(s) of Monetary Support

Please refer to primary and secondary sponsors