Multi-omics to Predict Responses to Biologics in IBD (MORE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Drug: Biologics

• Study Type: Observational
• Enrollment (Anticipated): 1050

Contacts and Locations

• Study Contact: Name: Hongsheng Yang, MD; Phone Number: +86-20-38663423; Email: hensonyang@foxmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Hongsheng Yang, MD; Phone Number: +86-20-38663423; Email: hensonyang@foxmail.com
      • Principal Investigator: Xiang Gao, MD
      • Sub-Investigator: Hongsheng Yang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory bowel disease treated with approved biologics

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-IBD control group; A control group in which patients are not diagnosed as inflammatory bowel disease.
CD group; A group in which patients are diagnosed as crohn's disease	Drug: Biologics; Infliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD
UC group; A group in which patients are diagnosed as ulcerative colitis	Drug: Biologics; Infliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Mucosal healing	Mucosal healing is defined as absence of mucosal ulceration	At week 42-64

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
EQ-5D score	EQ-5D score at baseline, week 14-26 and week 42-64	At baseline, week 14-26 and week 42-64
Incidence of adverse events	Incidence of adverse events through study completion	Through study completion

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 2022ZSLYEC-136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No