Ulcerative ColitisNCT07250815
A Study on Infections in Adults With Ulcerative Colitis/Crohn's Disease
An observational study of Ulcerative Colitis and Crohn's Disease, run by Takeda at 1 site in United States.
Trial summary
More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn's Disease (CD). This is happening because people are living longer and because more people overall are developing UC or CD. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2026to 15 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: United States (US) adult participants diagnosed with UC or CD who initiated ENTYVIO or other AMTs will be included in this study.
Who may be able to join
- UC Study Cohort:
- Participants will be included if they had:
- -Greater than or equal to (>=) 1 medical (for Medicare fee-for-service [FFS], Part A/B) or pharmacy claim (for Medicare FFS, Medicare Part D) for an approved AMT for UC during the participant identification period.
- Note: Claim should be on or after the food and drug administration (FDA) treatment-specific approval dates for each drug.
- The date of the first claim during the participant identification period will be designated the Index Date, and the corresponding AMT, the index AMT.
- >=2 medical (for Medicare FFS, Part A/B) claims, at least 30 days apart, with an ICD-10-CM code for UC during the baseline period or on the Index Date.
Show all 15Show fewer
- Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.
- CD Study Cohort:
- Participants will be included if they had:
- >=1 medical (for Medicare FFS, Part A/B) or pharmacy claim (for Medicare FFS, Part D) for an approved AMT for CD during the Participant Identification Period.
- Note: Claim should be on or after the FDA treatment-specific approval dates for each drug.
- The date of the first claim during the Patient Identification Period will be designated the Index Date, and the corresponding AMT, the index AMT.
- >=2 medical (for Medicare FFS, Part A/B) claims, at least 30 days apart, with an ICD-10-CM code for CD during the Baseline Period or on the Index Date.
- Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.
- If a participant has both a UC and CD diagnosis during the baseline period or on the index date, the diagnosis most proximate to or on the index date will be used to categorize the participant as having UC or CD.
Who cannot join
- Participants with any of the following will be excluded from the analysis:
- Any evidence of AMT utilization during the Baseline Period.
- Participants with at least 2 ICD-10-CM codes for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, non-infectious uveitis, or psoriatic arthritis during the Baseline Period.
- Participants with 2 or more ICD-10-CM codes for non-dermatologic malignancy during the Baseline Period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infection Outcomes Among Advanced Therapy-naive Older Adult US Patients With UC/CD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025
More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn's Disease (CD). This is happening because people are living longer and because more people overall are developing UC or CD. Medicines that treat UC/CD, however, might make it easier for older adults to get infections.
The main aim of this study is to learn if there is a difference in the number and type of infections in older people when treated with either ENTYVIO or other advance medicines (TNF-alpha inhibitors or ustekinumab) that reduce swelling and pain by blocking a chemical in the body (called TNF-alpha).
Read more
The study will include people aged 65 years and older UC or CD who used either ENTYVIO with ustekinumab or a TNF-alpha inhibitor between 2016 and 2025.
Data will be collected from existing Medicare databases.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- No intervention
- 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 an observational study, no intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Participants with UC | Participants diagnosed with UC who initiated treatment with ENTYVIO or other advanced medical therapies (AMTs) will be identified using a claims-based algorithm. This algorithm incorporates International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes, National Drug Codes (NDC), and Healthcare Common Procedural Coding System (HCPCS) codes to retrospectively assess the safety outcomes data over a period of approximately four months. Receives: Other: No intervention | |
| Participants with CD | Participants diagnosed with CD who initiated treatment with ENTYVIO or other AMTs will be identified using a claims-based algorithm. This algorithm incorporates ICD-10-CM codes, NDC, and HCPCS codes to retrospectively assess the safety outcomes data over a period of approximately four months. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Hospitalized Due to Serious Infections
Serious infections will include infections of the respiratory tract, skin and soft tissue, genitourinary tract, gastrointestinal tract, central nervous system, and septicemia/sepsis. The intraabdominal infections, perianal infections, tuberculosis, and other opportunistic infections will not be considered under serious infection requiring hospitalization.
Measured: Up to 4 months
Secondary outcomes (1)
Percentage of Participants with Non-serious Infections
Non-serious infections will include any primary diagnosis of infection that is not associated with hospitalization.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start21 Sep 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Why it stopped: Sponsor decision
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
- Retrospective
- Enrolment
- 0 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
- NCT07250815
- Sponsor's protocol ID
- Vedolizumab-4081
- Other IDs
- EUPAS1000000767
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2025
- Last updated
- 15 Oct 2026
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection Outcomes Among Advanced Therapy-naive Older Adult US Patients With UC/CD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025
- ClinicalTrials.gov ID
- NCT07250815
- Acronym / sponsor ID
- Vedolizumab-4081
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 26 Nov 2025 (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.
More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn's Disease (CD). This is happening because people are living longer and because more people overall are developing UC or CD. Medicines that treat UC/CD, however, might make it easier for older adults to get infections.
The main aim of this study is to learn if there is a difference in the number and type of infections in older people when treated with either ENTYVIO or other advance medicines (TNF-alpha inhibitors or ustekinumab) that reduce swelling and pain by blocking a chemical in the body (called TNF-alpha).
The study will include people aged 65 years and older UC or CD who used either ENTYVIO with ustekinumab or a TNF-alpha inhibitor between 2016 and 2025.
Data will be collected from existing Medicare databases.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with UC | – | Other: No interventionParticipants diagnosed with UC who initiated treatment with ENTYVIO or other advanced medical therapies (AMTs) will be identified using a claims-based algorithm. This algorithm incorporates International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes, National Drug Codes (NDC), and Healthcare Common Procedural Coding System (HCPCS) codes to retrospectively assess the safety outcomes data over a period of approximately four months. |
| Participants with CD | – | Other: No interventionParticipants diagnosed with CD who initiated treatment with ENTYVIO or other AMTs will be identified using a claims-based algorithm. This algorithm incorporates ICD-10-CM codes, NDC, and HCPCS codes to retrospectively assess the safety outcomes data over a period of approximately four months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- United States (US) adult participants diagnosed with UC or CD who initiated ENTYVIO or other AMTs will be included in this study.
Key inclusion criteria (15 listed)
- -Greater than or equal to (>=) 1 medical (for Medicare fee-for-service [FFS], Part A/B) or pharmacy claim (for Medicare FFS, Medicare Part D) for an approved AMT for UC during the participant identification period.
- Note: Claim should be on or after the food and drug administration (FDA) treatment-specific approval dates for each drug.
- The date of the first claim during the participant identification period will be designated the Index Date, and the corresponding AMT, the index AMT.
- >=2 medical (for Medicare FFS, Part A/B) claims, at least 30 days apart, with an ICD-10-CM code for UC during the baseline period or on the Index Date.
- Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.
Key exclusion criteria (4 listed)
- Any evidence of AMT utilization during the Baseline Period.
- Participants with at least 2 ICD-10-CM codes for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, non-infectious uveitis, or psoriatic arthritis during the Baseline Period.
- Participants with 2 or more ICD-10-CM codes for non-dermatologic malignancy during the Baseline Period.
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 an observational study, no intervention will be administered. | Other | Participants with CD, Participants with UC |
Primary outcome
Percentage of Participants Hospitalized Due to Serious Infections
Time frame: Up to 4 months
Serious infections will include infections of the respiratory tract, skin and soft tissue, genitourinary tract, gastrointestinal tract, central nervous system, and septicemia/sepsis. The intraabdominal infections, perianal infections, tuberculosis, and other opportunistic infections will not be considered under serious infection requiring hospitalization.
1 secondary outcome
Percentage of Participants with Non-serious Infections
Time frame: Up to 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.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.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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 United States.
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 15 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Oct 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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 Hospitalized Due to Serious Infections (time frame: Up to 4 months). 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 15 Oct 2026.