A Multicentered Prospective Cohort Study of Chinese IBD Patients

NCT ID: NCT05386290

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-09
• Study Completion Date: 2023-12-31

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.

Conditions

Ulcerative Colitis; Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

UC patients

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.

Infliximab

Intervention Type: DRUG

A TNFα inhibitor in UC and CD treatment

Vedolizumab

Intervention Type: DRUG

An integrin receptor antagonist in UC and CD treatment

conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)

Intervention Type: DRUG

Conventional treatment includes glucocoticoid, immunosupressive drugs and/or mesalazine. Immunosupressive drugs include azathioprine (AZA), methotrexate (MTX) and thalidomide (THA).

CD patients

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.

Infliximab

Intervention Type: DRUG

A TNFα inhibitor in UC and CD treatment

Ustekinumab

Intervention Type: DRUG

An IL-12/IL-23 inhibitor in CD treatment

conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)

Intervention Type: DRUG

Conventional treatment includes glucocoticoid, immunosupressive drugs and/or mesalazine. Immunosupressive drugs include azathioprine (AZA), methotrexate (MTX) and thalidomide (THA).

Interventions

Infliximab

A TNFα inhibitor in UC and CD treatment

Intervention Type: DRUG

Vedolizumab

An integrin receptor antagonist in UC and CD treatment

Intervention Type: DRUG

Ustekinumab

An IL-12/IL-23 inhibitor in CD treatment

Intervention Type: DRUG

conventional 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).

Intervention Type: DRUG

Other Intervention Names

IFX; VDZ; UST; glucocoticoid, immunosupressive drugs, mesalazine (5-ASA)

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hong Yang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Yang, Doctor

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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Other Identifiers

JS-3086

Identifier Type: -

Identifier Source: org_study_id