Inflammatory Bowel Disease (IBD)NCT05596422
A Study of Vedolizumab and Biologic Agents in Participants With Inflammatory Bowel Disease (IBD)
An observational study of Inflammatory Bowel Disease (IBD) and Ulcerative Colitis, run by Takeda at 4 sites in Taiwan.
Trial summary
This is a non-interventional, retrospective study of adult participants with IBD. IBD consists of either ulcerative colitis (UC) or Crohn's disease (CD). The study will review the clinical data previously collected during February 2007 to March 2020 of approximately 724 participants who have had treatment with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's Disease
- How many people
- 423 participants
- Where
- 4 sitesTaiwan
- Study dates
- 27 May 2021to 8 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed IBD participants treated with biologics including vedolizumab, adalimumab, infliximab, or golimumab will be included in this study.
Who may be able to join
- Diagnosed during February 2008 to March 2020 (or per local institutional review board [IRB] permitted date).
- CD (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]: 555.X or International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM]: K50.XX, K50.XXX)
- UC (ICD-9-CM: 556.X or ICD-10-CM: K51.XX, K51.XXX).
- Had received any dose of biologics for IBD treatment, including vedolizumab adalimumab, infliximab or golimumab, from February 2008 to March 2020 (or per local IRB permitted date).
Who cannot join
- 1. Participants with any suspected diagnosis of CD or UC within one year before the initial date of confirmed IBD diagnosis will be excluded.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
China Medical University Hospital
Taichung, 404327
Taichung Veterans General Hospital
Taichung, 40705
National Taiwan University Hospital
Taipei, 100229
Chang Gung Memorial Hospital-Linkou
Taoyuan, 333
About this study
Official title: Understand the Outcomes of Inflammatory Bowel Disease (IBD) Patients Treated With Biologics in Taiwan - A Decentralized Vedolizumab and Biologic Agents Core Assessments in IBD Collaboration
This is a non-interventional, retrospective study of adult participants with IBD. IBD consists of either ulcerative colitis (UC) or Crohn's disease (CD). The study will review the clinical data previously collected during February 2007 to March 2020 of approximately 724 participants who have had treatment with adalimumab, infliximab, golimumab, or vedolizumab in Taiwan.
Read the detailed description
This is a non-interventional, retrospective study in newly diagnosed IBD participants (UC or CD) treated with biologics.
The study will assess IBD relapse, effectiveness, and safety of biologic treatments in IBD participants. The study will enroll approximately 724 participants. The data will be collected from the electronic medical record (EMR) database of selected medical centers in Taiwan. IBD Participants who were evaluated and treated at the participating sites between 01 February 2007 to 31 March 2020 will be included. Participants will be assigned to the following two observational cohorts based on pathological diagnosis:
- Cohort 1: Participants With Biologics Discontinuation
- Cohort 2: Participants Treated With Biologics
This multi-center trial will be conducted in Taiwan. The overall duration of the study will be approximately 15 months.
- Keywords
- Drug Therapy
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Participants With Biologics Discontinuation | Participants with IBD (UC or CD) who had received biologic treatments for at least 6 months after the initial confirmed diagnosis of IBD, and with at least 3 months follow-up period after biologics discontinuation will be observed retrospectively. | |
| Cohort 2: Participants Treated With Biologics | Participants with IBD (UC or CD) who had any dose of biologic for IBD treatment after the initial confirmed diagnosis of IBD will be observed retrospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Had IBD Relapse
IBD Relapse includes re-treatment with biologics, steroid use, IBD-related hospitalization record, IBD-related ER visits, IBD-related surgery, increase in disease index. The occurrence of any of the above records will be regarded as an IBD relapse.
Measured: Up to approximately 13 years
Time to Relapse After Biologics Discontinuation
Time to relapse is defined as the time interval from end of treatment (EOT) to the first IBD relapse.
Measured: Up to approximately 13 years
Correlation Between the Clinical Variables and Relapse Post Biologics Discontinuation
The identifying predictors of relapse, survival distributions will be studied using the log-rank test for the univariate analysis and then using time dependent Cox regression models for the multivariate analysis. The potential confounders of relapse including demographics, disease status, IBD-related treatment, symptom control treatment, lab and complication will be assessed. Two predictive models will be built in the study, one is "on biologics treatment", and other is "off biologics treatment".
Measured: Up to approximately 13 years
Percentage of Participants Achieving Clinical Response
Clinical Response for CD is defined as Crohn's disease active index (CDAI) greater than or equal to (>=) 70 points reduction from the index date. For UC, Mayo score >=3 points reduction and >=30 percent (%) decrease from the index date with an accompanying rectal bleeding subscore >=1 points reduction or with absolute rectal bleeding subscore less than or equal to (<=) 1 and as >=2 point reduction in partial Mayo score. Index date: date when the first dose of the biologic was prescribed in each treatment cycle.
Measured: Up to approximately 13 years
Percentage of Participants Achieving Clinical Remission
Clinical Remission for CD is defined as CDAI <=150 point.CDAI assesses CD based on clinical signs such as number of liquid stools,intensity of abdominal pain,general wellbeing,presence of comorbid conditions,antidiarrheal use,physical examination and laboratory findings.Total score ranges from 0 to 600 points.Clinical Remission for UC is defined as Mayo score <=2 and no individual subscore >1 and partial Mayo score <=1.Mayo score measure disease activity of UC.Mayo score consists of 4 sub-scores: stool pattern,most severe rectal bleeding of the day,endoscopic findings,global assessment by physician,each graded from 0 to 3 with higher scores indicating more severe disease.Scores are summed to give a total score range of 0 to 12.Partial Mayo score consists of 3 sub-scores:stool pattern,most severe rectal bleeding of the day, global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease.Scores are summed to give a total score range of 0 to 9.
Measured: Up to approximately 13 years
Percentage of Participants Achieving Steroid-free Remission
Steroid-free remission for CD is defined as CDAI <=150 point. CDAI assesses CD based on clinical signs such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, antidiarrheal use, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Steroid-free remission for UC is defined as absence of steroid treatment (within 1 week before and after the date of potential clinical remission achieved) among participants on steroids at baseline (index date). Index date: date when the first dose of the biologic was prescribed in each treatment cycle.
Measured: Up to approximately 13 years
Percentage of Participants Achieving Mucosal Healing
Mucosal healing is defined as absence of any symptom finding of ulcer or spontaneous bleeding on endoscopic assessment or Crohn's Disease Endoscopic Index of Severity (CDEIS) less than (<) 4 for CD participants and as Mayo endoscopic subscore <=1 for UC participants.
Measured: Up to approximately 13 years
Correlation Between the Clinical Variables and Treatment Effectiveness
The relationship between clinical variables and treatment effectiveness will be assessed. The impact of potential bias from the baseline/demographic variables, baseline matching will be performed using propensity score 1:1 matching by each treatment cycle and different types of biologic treatments before performing the comparative analysis for effectiveness outcome. The matching condition will be determined according to the data collection. IBD participants with clinical response, clinical remission, steroid-free remission, and mucosal healing will be analyzed. The difference in effectiveness between IBD participants receiving different types of biologic treatment will be compared using Chi-square test.
Measured: Up to approximately 13 years
Percentage of Participants Experiencing Infection
Participants experiencing opportunistic infections, hepatic viral infections, gastrointestinal (GI) infections, respiratory infections, respiratory failure, or sepsis or septic shock among participants receiving vedolizumab versus those receiving anti-TNF-α will be assessed.
Measured: Up to approximately 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start27 May 2021
- Primary completion27 Oct 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Retrospective
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596422
- Sponsor's protocol ID
- Vedolizumab-4030
- Status last verified
- Jan 2023
- First submitted
- 24 Oct 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understand the Outcomes of Inflammatory Bowel Disease (IBD) Patients Treated With Biologics in Taiwan - A Decentralized Vedolizumab and Biologic Agents Core Assessments in IBD Collaboration
- ClinicalTrials.gov ID
- NCT05596422
- Acronym / sponsor ID
- Vedolizumab-4030
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 27 May 2021 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 27 Oct 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.
This is a non-interventional, retrospective study of adult participants with IBD. IBD consists of either ulcerative colitis (UC) or Crohn's disease (CD). The study will review the clinical data previously collected during February 2007 to March 2020 of approximately 724 participants who have had treatment with adalimumab, infliximab, golimumab, or vedolizumab in Taiwan.
Detailed description
This is a non-interventional, retrospective study in newly diagnosed IBD participants (UC or CD) treated with biologics.
The study will assess IBD relapse, effectiveness, and safety of biologic treatments in IBD participants. The study will enroll approximately 724 participants. The data will be collected from the electronic medical record (EMR) database of selected medical centers in Taiwan. IBD Participants who were evaluated and treated at the participating sites between 01 February 2007 to 31 March 2020 will be included. Participants will be assigned to the following two observational cohorts based on pathological diagnosis:
- Cohort 1: Participants With Biologics Discontinuation
- Cohort 2: Participants Treated With Biologics
This multi-center trial will be conducted in Taiwan. The overall duration of the study will be approximately 15 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Participants With Biologics Discontinuation | – | –Participants with IBD (UC or CD) who had received biologic treatments for at least 6 months after the initial confirmed diagnosis of IBD, and with at least 3 months follow-up period after biologics discontinuation will be observed retrospectively. |
| Cohort 2: Participants Treated With Biologics | – | –Participants with IBD (UC or CD) who had any dose of biologic for IBD treatment after the initial confirmed diagnosis of IBD will be observed retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed IBD participants treated with biologics including vedolizumab, adalimumab, infliximab, or golimumab will be included in this study.
Key inclusion criteria (4 listed)
- Diagnosed during February 2008 to March 2020 (or per local institutional review board [IRB] permitted date).
- Had received any dose of biologics for IBD treatment, including vedolizumab adalimumab, infliximab or golimumab, from February 2008 to March 2020 (or per local IRB permitted date).
Key exclusion criteria (1 listed)
- 1. Participants with any suspected diagnosis of CD or UC within one year before the initial date of confirmed IBD diagnosis will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Who Had IBD Relapse
Time frame: Up to approximately 13 years
IBD Relapse includes re-treatment with biologics, steroid use, IBD-related hospitalization record, IBD-related ER visits, IBD-related surgery, increase in disease index. The occurrence of any of the above records will be regarded as an IBD relapse.
Time to Relapse After Biologics Discontinuation
Time frame: Up to approximately 13 years
Time to relapse is defined as the time interval from end of treatment (EOT) to the first IBD relapse.
Correlation Between the Clinical Variables and Relapse Post Biologics Discontinuation
Time frame: Up to approximately 13 years
The identifying predictors of relapse, survival distributions will be studied using the log-rank test for the univariate analysis and then using time dependent Cox regression models for the multivariate analysis. The potential confounders of relapse including demographics, disease status, IBD-related treatment, symptom control treatment, lab and complication will be assessed. Two predictive models will be built in the study, one is "on biologics treatment", and other is "off biologics treatment".
Percentage of Participants Achieving Clinical Response
Time frame: Up to approximately 13 years
Clinical Response for CD is defined as Crohn's disease active index (CDAI) greater than or equal to (>=) 70 points reduction from the index date. For UC, Mayo score >=3 points reduction and >=30 percent (%) decrease from the index date with an accompanying rectal bleeding subscore >=1 points reduction or with absolute rectal bleeding subscore less than or equal to (<=) 1 and as >=2 point reduction in partial Mayo score. Index date: date when the first dose of the biologic was prescribed in each treatment cycle.
Percentage of Participants Achieving Clinical Remission
Time frame: Up to approximately 13 years
Clinical Remission for CD is defined as CDAI <=150 point.CDAI assesses CD based on clinical signs such as number of liquid stools,intensity of abdominal pain,general wellbeing,presence of comorbid conditions,antidiarrheal use,physical examination and laboratory findings.Total score ranges from 0 to 600 points.Clinical Remission for UC is defined as Mayo score <=2 and no individual subscore >1 and partial Mayo score <=1.Mayo score measure disease activity of UC.Mayo score consists of 4 sub-scores: stool pattern,most severe rectal bleeding of the day,endoscopic findings,global assessment by physician,each graded from 0 to 3 with higher scores indicating more severe disease.Scores are summed to give a total score range of 0 to 12.Partial Mayo score consists of 3 sub-scores:stool pattern,most severe rectal bleeding of the day, global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease.Scores are summed to give a total score range of 0 to 9.
Percentage of Participants Achieving Steroid-free Remission
Time frame: Up to approximately 13 years
Steroid-free remission for CD is defined as CDAI <=150 point. CDAI assesses CD based on clinical signs such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, antidiarrheal use, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Steroid-free remission for UC is defined as absence of steroid treatment (within 1 week before and after the date of potential clinical remission achieved) among participants on steroids at baseline (index date). Index date: date when the first dose of the biologic was prescribed in each treatment cycle.
Percentage of Participants Achieving Mucosal Healing
Time frame: Up to approximately 13 years
Mucosal healing is defined as absence of any symptom finding of ulcer or spontaneous bleeding on endoscopic assessment or Crohn's Disease Endoscopic Index of Severity (CDEIS) less than (<) 4 for CD participants and as Mayo endoscopic subscore <=1 for UC participants.
Correlation Between the Clinical Variables and Treatment Effectiveness
Time frame: Up to approximately 13 years
The relationship between clinical variables and treatment effectiveness will be assessed. The impact of potential bias from the baseline/demographic variables, baseline matching will be performed using propensity score 1:1 matching by each treatment cycle and different types of biologic treatments before performing the comparative analysis for effectiveness outcome. The matching condition will be determined according to the data collection. IBD participants with clinical response, clinical remission, steroid-free remission, and mucosal healing will be analyzed. The difference in effectiveness between IBD participants receiving different types of biologic treatment will be compared using Chi-square test.
Percentage of Participants Experiencing Infection
Time frame: Up to approximately 13 years
Participants experiencing opportunistic infections, hepatic viral infections, gastrointestinal (GI) infections, respiratory infections, respiratory failure, or sepsis or septic shock among participants receiving vedolizumab versus those receiving anti-TNF-α will be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- To obtain more information about this study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD) and Ulcerative Colitis, run by Takeda at 4 sites in Taiwan.
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 4 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: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants Who Had IBD Relapse (time frame: Up to approximately 13 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2023.