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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05542459
Other study ID # 2022ZSLYEC-136
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date November 1, 2024

Study information

Verified date September 2022
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact Hongsheng Yang, MD
Phone +86-20-38663423
Email hensonyang@foxmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Inflammatory bowel disease (IBD) is a chronic immune-related disease, which mainly affects the digestive tract. There are mainly two forms of the disease, including Crohn's disease (CD) and ulcerative colitis (UC). Biologics have revolutionized the treatment of inflammatory bowel disease with good efficacy and safety. However, 20-50% of patients may not response to or lose response to biologics. Unfortunately, there has been no factors or measures that may predict the efficacy or safety of biologics. In this study, a large prospective cohort study is conducted to evaluate the efficacy and safety of biologics (infliximab, adalimumab, vedolizumab, ustekinumab, and other approved biologics) in patients with inflammatory bowel disease in the real clinical practice. Meanwhile, a multi-omics approach involving transcriptomics, microbiome, proteomics, and metabolome, are adopted to explore biomarkers or factors that predict the therapeutic efficacy or safety of biologics. The mechanism underlie the disease will also be explored.


Recruitment information / eligibility

Status Recruiting
Enrollment 1050
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. For patients with IBD: - Patients with IBD treated with approved biologics - Age 18 or over - Written informed consent obtained from patient for participation 2. For non-IBD healthy volunteers: - Patients without the diagnosis of IBD or other conditions that, in the opinion of the investigator, not suitable to participate in the study - Age 18 or over - Written informed consent obtained from patient for participation Exclusion Criteria: - Unable to obtain written informed consent - Patient is, in the opinion of the investigator, not suitable to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Biologics
Infliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD

Locations

Country Name City State
China The Sixth Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical response The reduction of Crohn's Disease Activity Index (CDAI) =70 or CDAI <150 for Crohn's disease; a reduction of the Mayo Clinical Score =2 for ulcerative colitis At week 14-26
Primary Mucosal healing Mucosal healing is defined as absence of mucosal ulceration At week 42-64
Secondary Clinical response rate with steroids or without steroids Clinical response rate with steroids or without steroids at week 14-26 and week 42-64 At week 14-26 and week 42-64
Secondary Clinical remission rate with steroids or without steroids Clinical remission rate with steroids or without steroids at week 14-26 and week 42-64 At week 14-26 and week 42-64
Secondary Objective response rate Objective response was defined based on results obtained from at least 1 among endoscopy, bowel ultrasound, and computerized tomography (CT) or magnetic resonance (MR) enteroclysis at week 14-26 and week 42-64 At week 14-26 and week 42-64
Secondary Objective remission rate Objective remission was defined based on results obtained from at least 1 among endoscopy, bowel ultrasound, and computerized tomography (CT) or magnetic resonance (MR) enteroclysis at week 14-26 and week 42-64 At week 14-26 and week 42-64
Secondary Inflammatory Bowel Disease Questionnaire (IBDQ) score IBDQ score at baseline, week 14-26 and week 42-64 At baseline, week 14-26 and week 42-64
Secondary 36-Item Short Form Health Survey (SF-36) score SF-36 score at baseline, week 14-26 and week 42-64 At baseline, week 14-26 and week 42-64
Secondary EQ-5D score EQ-5D score at baseline, week 14-26 and week 42-64 At baseline, week 14-26 and week 42-64
Secondary Incidence of adverse events Incidence of adverse events through study completion Through study completion
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