Multi-omics to Predict Responses to Biologics in IBD

Study Overview
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Brief Summary
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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.

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

Conditions
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Crohn Disease, Ulcerative Colitis

Intervention / Treatment
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* Drug: Biologics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For patients with IBD: Patients with IBD treated with approved biologics Age 18 or over Written informed consent obtained from patient for participation 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 |