A Multicentered Prospective Cohort Study of Chinese IBD Patients

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05386290
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Infliximab — DRUG
    A TNFα inhibitor in UC and CD treatment
  • Vedolizumab — DRUG
    An integrin receptor antagonist in UC and CD treatment
  • Ustekinumab — DRUG
    An IL-12/IL-23 inhibitor in CD treatment
  • conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine) — DRUG
    Conventional treatment includes glucocoticoid, immunosupressive drugs and/or mesalazine. Immunosupressive drugs include azathioprine (AZA), methotrexate (MTX) and thalidomide (THA).

Study Details

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.

Key Dates

Start date
Jul 9, 2020
Status verified
May 2022
Primary completion
Sep 30, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

endoscopic remission rate at week 12 [ Time Frame: week 12 after treatment ]

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