Ulcerative ColitisNCT05626088
A Study in Adults With Inflammatory Bowel Disease (IBD) Receiving Vedolizumab in the Patient Support Program (PSP) in Brazil
An observational study of Ulcerative Colitis and Crohn's Disease, run by Takeda at 1 site in Brazil.
Trial summary
The primary reason of this study is to observe current and past treatment in adult participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Brazil. There is no treatment involved in this study, this is only an observational review of past and ongoing treatment data relating to Vedolizumab… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- How many people
- 1,006 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Apr 2023to 30 Jun 2026
- 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: Participants diagnosed with UC or CD with vedolizumab prescription, residing in Brazil and agree to participate in the program.
Who may be able to join
- Who participated or who will participate in the "Entre Nós" program and participant who consent to participate in the study.
Who cannot join
- No exclusion of participants is expected in the present study and the quality of the data relies in participant reported outcomes for the "Entre Nós" program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sociodemographic Characteristics, Vedolizumab Persistence and Outcomes in Inflammatory Bowel Disease Patients Participating in the Patient Support Program in Brazil
The primary reason of this study is to observe current and past treatment in adult participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Brazil. There is no treatment involved in this study, this is only an observational review of past and ongoing treatment data relating to Vedolizumab treatment for IBD (including Ulcerative Colitis [UC] and Crohn's Disease [CD]).
Read the detailed description
This is a non-interventional, observational study in participants with IBD participating in the PSP. This study will enroll approximately 2160 participants. The study is divided into two cohorts according to data collection:
- Retrospective Cohort
- Prospective Cohort
The retrospective cohort is for participants that were included in the PSP prior to study start. This retrospective cohort will have data of participants that are actively participating in the Program and only their retrospective data will be collected. The prospective cohort is for participants that are starting their participation in the PSP using their data from the consent date until the end of the study or until the discontinuation in the PSP or in the study.
Retrospective and prospective cohorts will be collected from the PSP database, which will be the only source of participants for this study.
This single country trial will be conducted in Brazil. The duration of this observational study will be approximately 26 months.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- No Intervention
- Keywords
- Drug Therapy
- 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.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Participants diagnosed with UC or CD with prescription of vedolizumab, and were included in the PSP program (which has started in 2016) before the study starts will be observed retrospectively in this study. Receives: Other: No Intervention | |
| Prospective Cohort | Participants diagnosed with UC or CD with prescription of vedolizumab, and have participation in PSP after the study start will be observed prospectively in this study. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Vedolizumab Treatment Persistence for Conventional Therapy and Advanced Therapies
Treatment persistence will be defined as participants who did not discontinue treatment during follow-up. Advance therapies include biologics and tofacitinib.
Measured: Up to approximately 9 years
Secondary outcomes (9)
Number of Participants With Therapies Used Before Vedolizumab Treatment
Measured: Up to approximately 9 years
Number of Participants With Vedolizumab Treatment Scheme (Dose Escalation and De-escalation) for Conventional and Advanced Therapies
Advance therapies include biologics and tofacitinib.
Measured: Up to approximately 9 years
Number of Participants With Comorbidities Associated or not With CD or UC
Measured: Up to approximately 9 years
Duration of Disease
Measured: Up to approximately 9 years
Percentage of Participants Diagnosed With UC or CD
Measured: Up to approximately 9 years
Percentage of Participants With Vedolizumab Drug Administration Route: Intravenous (IV) or Subcutaneous (SC)
Measured: Up to approximately 9 years
Number of Participants Based on Quality-of-life (QOL) as Assessed by Short Inflammatory Bowel Disease Questionnaire 10 (SIBDQ-10) in Prospective Cohort
The SIBDQ is a validated tool used by health care professionals for assessment of participant's inflammatory bowel disease. SIBDQ contains 10 (ten) questions, and each question is composed of the 7 (seven) levels of self-perception of feeling or mood, giving an absolute score ranging from 10 (poor health related QoL) to 70 (optimal health related QoL), higher scores mean better quality of life. Index date will be defined as the start of the vedolizumab treatment.
Measured: At the index date (vedolizumab initiation), and at 14 and 52 weeks from index date
Percentage of Participants With Adverse Events (AEs) or Serious AEs During Vedolizumab use for UC and CD
Measured: Up to approximately 9 years
Number of Participants With Reason for Discontinuing the Vedolizumab Treatment for Conventional Therapy and Experiences Anti-TNF
Measured: Up to approximately 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start10 Apr 2023
- Primary completion27 Dec 2024
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Other
- Enrolment
- 1,006 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
- NCT05626088
- Sponsor's protocol ID
- Vedolizumab-4045
- Other IDs
- MACS-2022-042701
- Status last verified
- Aug 2026
- First submitted
- 16 Nov 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sociodemographic Characteristics, Vedolizumab Persistence and Outcomes in Inflammatory Bowel Disease Patients Participating in the Patient Support Program in Brazil
- ClinicalTrials.gov ID
- NCT05626088
- Acronym / sponsor ID
- Vedolizumab-4045
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 23 Nov 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.
The primary reason of this study is to observe current and past treatment in adult participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Brazil. There is no treatment involved in this study, this is only an observational review of past and ongoing treatment data relating to Vedolizumab treatment for IBD (including Ulcerative Colitis [UC] and Crohn's Disease [CD]).
Detailed description
This is a non-interventional, observational study in participants with IBD participating in the PSP. This study will enroll approximately 2160 participants. The study is divided into two cohorts according to data collection:
- Retrospective Cohort
- Prospective Cohort
The retrospective cohort is for participants that were included in the PSP prior to study start. This retrospective cohort will have data of participants that are actively participating in the Program and only their retrospective data will be collected. The prospective cohort is for participants that are starting their participation in the PSP using their data from the consent date until the end of the study or until the discontinuation in the PSP or in the study.
Retrospective and prospective cohorts will be collected from the PSP database, which will be the only source of participants for this study.
This single country trial will be conducted in Brazil. The duration of this observational study will be approximately 26 months.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Other: No InterventionParticipants diagnosed with UC or CD with prescription of vedolizumab, and were included in the PSP program (which has started in 2016) before the study starts will be observed retrospectively in this study. |
| Prospective Cohort | – | Other: No InterventionParticipants diagnosed with UC or CD with prescription of vedolizumab, and have participation in PSP after the study start will be observed prospectively in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with UC or CD with vedolizumab prescription, residing in Brazil and agree to participate in the program.
Key inclusion criteria (1 listed)
- Who participated or who will participate in the "Entre Nós" program and participant who consent to participate in the study.
Key exclusion criteria (1 listed)
- No exclusion of participants is expected in the present study and the quality of the data relies in participant reported outcomes for the "Entre Nós" program.
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 |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Prospective Cohort, Retrospective Cohort |
Primary outcome
Number of Participants With Vedolizumab Treatment Persistence for Conventional Therapy and Advanced Therapies
Time frame: Up to approximately 9 years
Treatment persistence will be defined as participants who did not discontinue treatment during follow-up. Advance therapies include biologics and tofacitinib.
9 secondary outcomes
Number of Participants With Therapies Used Before Vedolizumab Treatment
Time frame: Up to approximately 9 years
Number of Participants With Vedolizumab Treatment Scheme (Dose Escalation and De-escalation) for Conventional and Advanced Therapies
Time frame: Up to approximately 9 years
Number of Participants With Comorbidities Associated or not With CD or UC
Time frame: Up to approximately 9 years
Duration of Disease
Time frame: Up to approximately 9 years
Percentage of Participants Diagnosed With UC or CD
Time frame: Up to approximately 9 years
Percentage of Participants With Vedolizumab Drug Administration Route: Intravenous (IV) or Subcutaneous (SC)
Time frame: Up to approximately 9 years
Number of Participants Based on Quality-of-life (QOL) as Assessed by Short Inflammatory Bowel Disease Questionnaire 10 (SIBDQ-10) in Prospective Cohort
Time frame: At the index date (vedolizumab initiation), and at 14 and 52 weeks from index date
Percentage of Participants With Adverse Events (AEs) or Serious AEs During Vedolizumab use for UC and CD
Time frame: Up to approximately 9 years
Number of Participants With Reason for Discontinuing the Vedolizumab Treatment for Conventional Therapy and Experiences Anti-TNF
Time frame: Up to approximately 9 years
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 7 Aug 2026.
- Click here for more information about this trial in easy-to-understand language.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.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
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's Disease, run by Takeda at 1 site in Brazil.
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 1 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 7 Aug 2026. 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 Brazil. 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?
Number of Participants With Vedolizumab Treatment Persistence for Conventional Therapy and Advanced Therapies (time frame: Up to approximately 9 years). 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 7 Aug 2026.