Multi-omics to Predict Responses to Biologics in IBD

Sixth Affiliated Hospital, Sun Yat-sen University1,050 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,050

Conditions

Crohn Disease Ulcerative Colitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: At week 14-26

Mucosal healing

Mucosal healing is defined as absence of mucosal ulceration

Time frame: At week 42-64

Secondary Outcomes

Clinical response rate with steroids or without steroids

Clinical response rate with steroids or without steroids at week 14-26 and week 42-64

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: At baseline, week 14-26 and week 42-64

EQ-5D score

EQ-5D score at baseline, week 14-26 and week 42-64

Time frame: At baseline, week 14-26 and week 42-64

Incidence of adverse events

Incidence of adverse events through study completion

Time frame: Through study completion

Multi-omics to Predict Responses to Biologics in IBD

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts