A Multicentered Prospective Cohort Study of Chinese IBD Patients

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05386290
• Other study ID #: JS-3086
• Status: Enrolling by invitation
• Start date: July 9, 2020
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Ulcerative Colitis

Intervention

Drug:
• Infliximab
A TNFa inhibitor in UC and CD treatment
• Vedolizumab
An integrin receptor antagonist in UC and CD treatment
• Ustekinumab
An IL-12/IL-23 inhibitor in CD treatment
• 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).

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Jean L, Audrey M, Beauchemin C, Consortium OBOTI. Economic Evaluations of Treatments for Inflammatory Bowel Diseases: A Literature Review. Can J Gastroenterol Hepatol. 2018 Jun 13;2018:7439730. doi: 10.1155/2018/7439730. eCollection 2018. Review. — View Citation

Lv H, Jin M, Zhang H, Chen X, Wu M, Guo M, Zhou R, Wang Z, Yang H, Qian J. Increasing newly diagnosed inflammatory bowel disease and improving prognosis in China: a 30-year retrospective study from a single centre. BMC Gastroenterol. 2020 Nov 12;20(1):377. doi: 10.1186/s12876-020-01527-1. Erratum in: BMC Gastroenterol. 2022 Mar 8;22(1):109. — View Citation

Ng SC, Kaplan GG, Tang W, Banerjee R, Adigopula B, Underwood FE, Tanyingoh D, Wei SC, Lin WC, Lin HH, Li J, Bell S, Niewiadomski O, Kamm MA, Zeng Z, Chen M, Hu P, Ong D, Ooi CJ, Ling KL, Miao Y, Miao J, Janaka de Silva H, Niriella M, Aniwan S, Limsrivilai J, Pisespongsa P, Wu K, Yang H, Ng KK, Yu HH, Wang Y, Ouyang Q, Abdullah M, Simadibrata M, Gunawan J, Hilmi I, Lee Goh K, Cao Q, Sheng H, Ong-Go A, Chong VH, Ching JYL, Wu JCY, Chan FKL, Sung JJY. Population Density and Risk of Inflammatory Bowel Disease: A Prospective Population-Based Study in 13 Countries or Regions in Asia-Pacific. Am J Gastroenterol. 2019 Jan;114(1):107-115. doi: 10.1038/s41395-018-0233-2. — View Citation

Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16. Review. Erratum in: Lancet. 2020 Oct 3;396(10256):e56. — View Citation

Ouyang Q, Xue LY. Inflammatory bowel disease in the 21(st) century in China: turning challenges into opportunities. J Dig Dis. 2012 Apr;13(4):195-9. doi: 10.1111/j.1751-2980.2012.00579.x. — View Citation

Pillai N, Dusheiko M, Burnand B, Pittet V. A systematic review of cost-effectiveness studies comparing conventional, biological and surgical interventions for inflammatory bowel disease. PLoS One. 2017 Oct 3;12(10):e0185500. doi: 10.1371/journal.pone.0185500. eCollection 2017. Review. — View Citation

Solberg IC, Lygren I, Jahnsen J, Aadland E, Høie O, Cvancarova M, Bernklev T, Henriksen M, Sauar J, Vatn MH, Moum B; IBSEN Study Group. Clinical course during the first 10 years of ulcerative colitis: results from a population-based inception cohort (IBSEN Study). Scand J Gastroenterol. 2009;44(4):431-40. doi: 10.1080/00365520802600961. — View Citation

Torabi M, Bernstein CN, Yu BN, Wickramasinghe L, Blanchard JF, Singh H. Geographical Variation and Factors Associated With Inflammatory Bowel Disease in a Central Canadian Province. Inflamm Bowel Dis. 2020 Mar 4;26(4):581-590. doi: 10.1093/ibd/izz168. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	side effect rate at week 0,12 and 52	side effect includes medication side effects, infection, reactivation of tuberculosis or hepatitis B, cancer, etc.	week 0, week 12 and week 52 after treatment
Primary	endoscopic remission rate at week 12	Endoscopic remission is defined as Mayo endoscopic subscore =1.	week 12 after treatment
Secondary	clinical remission at week 0, 12 and 52	Clinical remission: defined as a Mayo score =2 and no individual subscore >1.	week 0, week 12 and week 52 after treatment