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

NCT05386290 UNKNOWN

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.

Details

Lead sponsor	Peking Union Medical College Hospital
Status	UNKNOWN
Enrolment	200
Start date	2020-07-09
Completion	2023-12

Conditions

• Ulcerative Colitis
• Crohn Disease

Interventions

• Infliximab
• Vedolizumab
• Ustekinumab
• conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)

Primary outcomes

• endoscopic remission rate at week 12 — week 12 after treatment
  Endoscopic remission is defined as Mayo endoscopic subscore ≤1.

Countries

China