Multi-omics to Predict Responses to Biologics in IBD

Recruiting

• Conditions: Crohn Disease; Ulcerative Colitis
• Interventions: Drug: Biologics

• Registration Number: NCT05542459
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-10
• Study First Submitted QC: 2022-09-14
• Last Update Submitted: 2022-09-14
• Study First Posted: 2022-09-15
• Last Update Posted: 2022-09-15
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1050

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UC group	Biologics	A group in which patients are diagnosed as ulcerative colitis
CD group	Biologics	A group in which patients are diagnosed as crohn's disease

Primary Outcome Measures

Name	Time	Method
Mucosal healing	At week 42-64	Mucosal healing is defined as absence of mucosal ulceration
Clinical response	At week 14-26	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

Secondary Outcome Measures

Name	Time	Method
Clinical response rate with steroids or without steroids	At week 14-26 and week 42-64	Clinical response rate with steroids or without steroids at week 14-26 and week 42-64
EQ-5D score	At baseline, week 14-26 and week 42-64	EQ-5D score at baseline, week 14-26 and week 42-64
Clinical remission rate with steroids or without steroids	At week 14-26 and week 42-64	Clinical remission rate with steroids or without steroids at week 14-26 and week 42-64
Objective response rate	At week 14-26 and week 42-64	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
36-Item Short Form Health Survey (SF-36) score	At baseline, week 14-26 and week 42-64	SF-36 score at baseline, week 14-26 and week 42-64
Incidence of adverse events	Through study completion	Incidence of adverse events through study completion
Inflammatory Bowel Disease Questionnaire (IBDQ) score	At baseline, week 14-26 and week 42-64	IBDQ score at baseline, week 14-26 and week 42-64
Objective remission rate	At week 14-26 and week 42-64	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

Trial Locations

Locations (1)

The Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China