Ulcerative ColitisNCT05386290
A Multicentered Prospective Cohort Study of Chinese IBD Patients
An observational study of Ulcerative Colitis and Crohn Disease, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease
- What is being tested?
- Infliximab, Vedolizumab and Ustekinumab
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2020to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- with complex complications
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: A Multicentered Prospective Cohort Study of Chinese IBD Patients Concerning Cost-effectiveness Analysis, Therapeutic Effect Predictor Exploration and Gut Microbiota Analysis
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.
Read the detailed 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.
- Conditions
- Ulcerative Colitis, Crohn Disease
- Being tested
- Infliximab, Vedolizumab, Ustekinumab, conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called IFX
A TNFα inhibitor in UC and CD treatment
VedolizumabDrug
Also called VDZ
An integrin receptor antagonist in UC and CD treatment
UstekinumabDrug
Also called UST
An IL-12/IL-23 inhibitor in CD treatment
conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)Drug
Also called glucocoticoid, immunosupressive drugs, mesalazine (5-ASA)
Conventional treatment includes glucocoticoid, immunosupressive drugs and/or mesalazine. Immunosupressive drugs include azathioprine (AZA), methotrexate (MTX) and thalidomide (THA).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Infliximab; Drug: Ustekinumab; Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopic remission rate at week 12
Endoscopic remission is defined as Mayo endoscopic subscore ≤1.
Measured: week 12 after treatment
Secondary outcomes (1)
clinical remission at week 0, 12 and 52
Clinical remission: defined as a Mayo score ≤2 and no individual subscore >1.
Measured: week 0, week 12 and week 52 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start9 Jul 2020
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Yang, Peking Union Medical College Hospital
- Investigators
- Hong Yang, Doctor, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386290
- Sponsor's protocol ID
- JS-3086
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 23 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31504519Ng 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.
PubMed 29050646Ouyang 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.
PubMed 22435503Ng 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.
PubMed 30177785Solberg 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.
PubMed 19101844Lv 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.
PubMed 33183228Pillai 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.
PubMed 28973005Jean 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.
PubMed 30009158
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentered Prospective Cohort Study of Chinese IBD Patients Concerning Cost-effectiveness Analysis, Therapeutic Effect Predictor Exploration and Gut Microbiota Analysis
- ClinicalTrials.gov ID
- NCT05386290
- Acronym / sponsor ID
- JS-3086
- Conditions
- Ulcerative Colitis, Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC patients | – | Drug: Infliximab, Drug: Vedolizumab, Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)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. |
| CD patients | – | Drug: Infliximab, Drug: Ustekinumab, Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)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. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- with complex complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabAlso: IFXA TNFα inhibitor in UC and CD treatment | Drug | CD patients, UC patients |
| VedolizumabAlso: VDZAn integrin receptor antagonist in UC and CD treatment | Drug | UC patients |
| UstekinumabAlso: USTAn IL-12/IL-23 inhibitor in CD treatment | Drug | CD patients |
| conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine)Also: glucocoticoid, immunosupressive drugs, mesalazine (5-ASA)Conventional treatment includes glucocoticoid, immunosupressive drugs and/or mesalazine. Immunosupressive drugs include azathioprine (AZA), methotrexate (MTX) and thalidomide (THA). | Drug | CD patients, UC patients |
Primary outcome
endoscopic remission rate at week 12
Time frame: week 12 after treatment
Endoscopic remission is defined as Mayo endoscopic subscore ≤1.
1 secondary outcome
clinical remission at week 0, 12 and 52
Time frame: week 0, week 12 and week 52 after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 31504519Torabi 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.
- Background: PubMed 29050646Ng 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.
- Background: PubMed 22435503Ouyang 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.
- Background: PubMed 30177785Ng 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.
- Background: PubMed 19101844Solberg 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.
- Background: PubMed 33183228Lv 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.
- Background: PubMed 28973005Pillai 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.
- Background: PubMed 30009158Jean 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Yang, Doctor study chair
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn Disease, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endoscopic remission rate at week 12 (time frame: week 12 after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05386290, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.