A Multicentered Prospective Cohort Study of Chinese IBD Patients

Study Overview
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Brief Summary
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Inflammatory bowel disease(IBD), including ulcerative colitis (UC) and Crohn's disease (CD), is characterized by chronic and recurrent nonspecific intestinal inflammation with high disability rate. During the past few decades, the prevalence of IBD is increasing, especially in developing countries, which brings great burden to patients themselves and medical insurance. Currently, biological medications such as TNFα inhibitors (infliximab, adalimumab, etc.), integrin receptor antagonist (vedolizumab) and interleukin 12/interleukin 23 inhibitor (ustekinumab) are commonly used in IBD treatment as well as traditional drugs such as glucocorticoid, immunosupressive agents and 5-Aminosalicylic Acid, and surgury. However, health-econimic analysis is lacking in Chinese IBD patients and more research is needed for making treatment choice. Meanwhile, the etiology, disease progression and prognosis prediction has not totally been clarified. The efficacy prediction model of vedolizumab and infliximab has been analyzed, whose prediction markers include level of albumin, smoking, surgery history, fistula, etc. However, no model has included predictors concerning disease pathway or pharmacological pathway in patients accepting different therapy. So a model to predict IBD progression and prognosis concerning pharmacological pathway is going to be explored.

Detailed Description
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The research is aimed at exploring the mode of IBD progression and predicting prognosis of different IBD patients so that treatment choice could be made to get better efficacy and decrease economic burden of patients and medical insurance. So blood and stool samples before and after treatment are collected to detect changes in gut microbiota and blood proteomics markers and explore the prediction model. Also, inflammatory bowel disease questionnaire (IBDQ) and EQ5D3L will be collected and cost-utility analysis will be conducted.

Official Title
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A Multicentered Prospective Cohort Study of Chinese IBD Patients Concerning Cost-effectiveness Analysis, Therapeutic Effect Predictor Exploration and Gut Microbiota Analysis

Conditions
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Ulcerative Colitis, Crohn Disease

Intervention / Treatment
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* Drug: Infliximab
* Drug: Vedolizumab
* Drug: Ustekinumab
* Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be diagnosed CD or UC according to Chinese consensus on diagnosis and treatment in inflammatory bowel disease(2018, Beijing) willing to be followed up intend to be treated by biological agents (VDZ, IFX or UST) or conventional drugs (glucocoticoid±immunosupressive drugs±5-ASA) Exclusion Criteria: with complex complications

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UC patients<br>Patients who were diagnosed moderate-to-severe ulcerative colitis (UC) and intend to be treated by biological agents (infliximab or vedolizumab) or traditional drugs (glucocoticoid, immunosupressive drugs and/or mesalazine) will be enrolled. | Drug: Infliximab<br>* A TNFα inhibitor in UC and CD treatment<br>* Other names: IFX;Drug: Vedolizumab<br>* An integrin receptor antagonist in UC and CD treatment<br>* Other names: VDZ;Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)<br>* Conventional treatment includes glucocoticoid, immunosupressive drugs and/or mesalazine. Immunosupressive drugs include azathioprine (AZA), methotrexate (MTX) and thalidomide (THA).<br>* Other names: glucocoticoid, immunosupressive drugs, mesalazine (5-ASA);|
| CD patients<br>Patients who were diagnosed moderate-to-severe Crohn's Disease (CD) and intend to be treated by biological agents (infliximab or ustekinumab) or traditional drugs (glucocoticoid, immunosupressive drugs and/or mesalazine) will be enrolled. | Drug: Infliximab<br>* A TNFα inhibitor in UC and CD treatment<br>* Other names: IFX;Drug: Ustekinumab<br>* An IL-12/IL-23 inhibitor in CD treatment<br>* Other names: UST;Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)<br>* Conventional treatment includes glucocoticoid, immunosupressive drugs and/or mesalazine. Immunosupressive drugs include azathioprine (AZA), methotrexate (MTX) and thalidomide (THA).<br>* Other names: glucocoticoid, immunosupressive drugs, mesalazine (5-ASA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endoscopic remission rate at week 12 | Endoscopic remission is defined as Mayo endoscopic subscore ≤1. | week 12 after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical remission at week 0, 12 and 52 | Clinical remission: defined as a Mayo score ≤2 and no individual subscore >1. | week 0, week 12 and week 52 after treatment |