Multi-omics to Predict Responses to Biologics in IBD

Ulcerative Colitis Clinical Trial

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Official title:

Multi-omics to Predict Responses to Biologics in Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542459
• Other study ID #: 2022ZSLYEC-136
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Crohn Disease
• Ulcerative Colitis

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