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A Multicentered Prospective Cohort Study of Chinese IBD Patients

NCT05386290 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-05-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Infliximab

A TNFα inhibitor in UC and CD treatment

DRUG

Vedolizumab

An integrin receptor antagonist in UC and CD treatment

DRUG

Ustekinumab

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

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).

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Hong Yang, Doctor · Peking Union Medical College Hospital

Eligibility

Min Age
14 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-09
Primary Completion
2023-09-30
Completion
2023-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386290 on ClinicalTrials.gov