A Multicentered Prospective Cohort Study of Chinese IBD Patients

May 17, 2022 updated by: Hong Yang, Peking Union Medical College Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 76 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This is a multicentered research and Chinese patients who meet the eligibility criteria will be enrolled. The medical centers are Peking Union Medical College Hospital, Beijing Chaoyang Hospital, Peking University Third Hospital, Beijing Shijingshan Hospital and the 7th Medical Center of PLA General Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Infliximab
A TNFα inhibitor in UC and CD treatment
Other Names:
  • IFX
Drug: Vedolizumab
An integrin receptor antagonist in UC and CD treatment
Other Names:
  • VDZ
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).
Other Names:
  • glucocoticoid, immunosupressive drugs, mesalazine (5-ASA)
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.
Drug: Infliximab
A TNFα inhibitor in UC and CD treatment
Other Names:
  • IFX
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).
Other Names:
  • glucocoticoid, immunosupressive drugs, mesalazine (5-ASA)
Drug: Ustekinumab
An IL-12/IL-23 inhibitor in CD treatment
Other Names:
  • UST

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effect rate at week 0,12 and 52
Time Frame: week 0, week 12 and week 52 after treatment
side effect includes medication side effects, infection, reactivation of tuberculosis or hepatitis B, cancer, etc.
week 0, week 12 and week 52 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Hong Yang, Doctor, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2020

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-3086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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