Crohn Disease, Ulcerative Colitis
Conditions
Brief summary
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
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.
Interventions
DRUGInfliximab
A TNFα inhibitor in UC and CD treatment
DRUGVedolizumab
An integrin receptor antagonist in UC and CD treatment
DRUGUstekinumab
An IL-12/IL-23 inhibitor in CD treatment
DRUGconventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)
Conventional treatment includes glucocoticoid, immunosupressive drugs and/or mesalazine. Immunosupressive drugs include azathioprine (AZA), methotrexate (MTX) and thalidomide (THA).
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endoscopic remission rate at week 12 | week 12 after treatment | Endoscopic remission is defined as Mayo endoscopic subscore ≤1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical remission at week 0, 12 and 52 | week 0, week 12 and week 52 after treatment | Clinical remission: defined as a Mayo score ≤2 and no individual subscore \>1. |
Other
| Measure | Time frame | Description |
|---|---|---|
| side effect rate at week 0,12 and 52 | week 0, week 12 and week 52 after treatment | side effect includes medication side effects, infection, reactivation of tuberculosis or hepatitis B, cancer, etc. |
Countries
China
Outcome results
None listed