A Multicentered Prospective Cohort Study of Chinese IBD Patients

NCT05386290 | Unknown FDA Drug

• 1 other identifier: JS-3086
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Ulcerative Colitis; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• endoscopic remission rate at week 12

  Endoscopic remission is defined as Mayo endoscopic subscore ≤1.

  week 12 after treatment

Secondary Outcomes (1)

• clinical remission at week 0, 12 and 52

  week 0, week 12 and week 52 after treatment

Other Outcomes (1)

• side effect rate at week 0,12 and 52

  week 0, week 12 and week 52 after treatment

Study Arms (2)

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; Drug: Vedolizumab; Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)

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; Drug: Ustekinumab; Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)

Interventions

Infliximab DRUG

A TNFα inhibitor in UC and CD treatment

Also known as: IFX

CD patients; UC patients

Vedolizumab DRUG

An integrin receptor antagonist in UC and CD treatment

Also known as: VDZ

UC patients

Ustekinumab DRUG

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

Also known as: UST

CD patients

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).

Also known as: glucocoticoid, immunosupressive drugs, mesalazine (5-ASA)

CD patients; UC patients

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• with complex complications

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (8)

• 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.

  PMID: 31504519 BACKGROUND

• 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.

  PMID: 29050646 BACKGROUND

• 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.

  PMID: 22435503 BACKGROUND

• 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.

  PMID: 30177785 BACKGROUND

• Solberg IC, Lygren I, Jahnsen J, Aadland E, Hoie 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.

  PMID: 19101844 BACKGROUND

• 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.

  PMID: 33183228 BACKGROUND

• 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.

  PMID: 28973005 BACKGROUND

• 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.

  PMID: 30009158 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Patients' residual blood sample after test and stool specimen are collected.

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

Infliximab; vedolizumab; Ustekinumab; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Hong Yang, Doctor

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 23, 2022
• Study Start: July 9, 2020
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)