Inflammatory Bowel Disease (IBD)NCT07123350
Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease (IBD) and Crohn&Amp;#39;s Disease (CD), run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this retrospective study is to learn about dosing patterns in patients starting subcutaneous vedolizumab administration and patient outcomes after starting subcutaneous administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Crohn&Amp;#39;s Disease (CD), Ulcerative Colitis (UC)
- What is being tested?
- Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient care
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients were identified if they were seen in the VUMC IBD clinic as part of normal clinical practice
Who may be able to join
- Patients with Crohn's Disease or Ulcerative Colitis referred to start SC vedolizumab from a VUMC IBD provider and receive at least 1 dose of subcutaneous vedolizumab
- Age 18 years old or older
Who cannot join
- Patients prescribed SC vedolizumab from a non-VUMC provider
- Patients lost to follow-up or change in provider or medication before SC formulation started
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37211
About this study
Official title: Evolving Biologic Administration: Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease
The goal of this retrospective study is to learn about dosing patterns in patients starting subcutaneous vedolizumab administration and patient outcomes after starting subcutaneous administration.
Patients with IBD who are starting subcutaneous vedolizumab administration between September 1, 2023, and March 31, 2025, as part of normal patient care, will be retrospectively reviewed and analyzed.
Read the detailed description
Vedolizumab intravenous (IV) infusions have been a first-line treatment option for patients with inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC) for over ten years. Recently, vedolizumab has been approved by the Food and Drug Administration for subcutaneous (SC) administration in the United States, offering patients a more convenient treatment option with medication administration at home. Evidence, largely from European countries where the SC formulation of vedolizumab has been available since 2020, shows a durable and potentially improved clinical response when switching to the SC formulation. A high SC treatment persistence has been found, mainly above 80%. Additionally, many patients accept the transition to SC vedolizumab as a safe and feasible treatment option and noting that the shorter treatment duration was specifically advantageous.
Current evidence is limited by the minimal amount of data on patients transitioning from IV to SC vedolizumab. For treatment with vedolizumab IV to SC, large scale, real-life studies with long term follow-up are necessary. More research is needed to further evaluate predictors for a relapse when transitioning from IV to SC therapy that have been seen in previous studies, including older age, escalated IV dosing, fecal calprotectin >250 microgram/gram at baseline, and CRP > 2g/L at baseline. We must also evaluate patient clinical outcomes after switching from IV to SC vedolizumab or infliximab and potential predictors for a positive response. These results will drive clinical decisions and further understanding of treatment expectations.
There is also a large gap in available information on standard and escalated dosing patterns before and after switching from IV to SC vedolizumab. Minimal research has evaluated whether or not patients on escalated IV dosing maintain escalated dosing at the time of switch or initiate standard SC dosing. There is a pressing need to understand dosing patterns in patients transitioning from escalated IV dosing to SC administration and patient outcomes after switching to SC administration based on dosing.
The proposed study would meet current gaps in literature by evaluating 1) clinical outcomes in patients with CD and UC switching from IV to SC vedolizumab and 2) dosing patterns from standard or escalated IV dosing at baseline to standard or escalated SC dosing, including switching practices and outcomes.
- Being tested
- Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient care
- Keywords
- Inflammatory Bowel Disease, Health-system Specialty Pharmacy, Vedolizumab
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient careDrug
This study does not include any subject enrollment or randomization. This is a retrospective cohort review of patients referred to start subcutaneous vedolizumab from a VUMC IBD provider.
| Study group | Role | What they receive |
|---|---|---|
| IV to SC switch | Patients with Crohn's Disease (CD) or Ulcerative Colitis (UC) referred to switch to subcutaneous vedolizumab from IV vedolizumab from a VUMC IBD provider and receive at least 1 dose of subcutaneous vedolizumab Receives: Drug: Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Defined as clinical remission assessed and written by provider in the office visit note
Measured: baseline with IV dosing, and 3, 6, 9, 12 months after switching to SC
Secondary outcomes (9)
Endoscopic Remission
Endoscopic remission as seen by provider after colonoscopy assessment
Measured: at baseline with IV dosing and within 12 months after switching to SC
Dosing patterns of IV dose/frequency and SC dose/frequency
standard dosing vs escalated dosing; includes any dose changes of the SC product within 12 months after switching from IV to SC
Measured: At baseline and up to 12 months after switching
SIBDQ score
Short Inflammatory Bowel Disease Questionnaire: 10-item validated health-related quality of life tool that measures physical, social, and emotional status. It is designed to evaluate how the patient is feeling over the past two weeks. The 10 questions are given scores of 1 to 7 with an overall score of 10 to 70. The lower the score, the more severe the disease is impacting the patient's quality of life (QOL).
Measured: Baseline and 12 months post switch to SC
Persistence to SC formulation
Measured by time to discontinuation; will include reason for discontinuation if SC stopped
Measured: Up to 12 months after switching
Adverse events to vedolizumab SC
Adverse events to vedolizumab SC that required change back to IV
Measured: Up to 12 months after switching
Adherence
Measured by PDC
Measured: 12 months post switch to SC
Patient-reported missed doses
For patients filling with Vanderbilt Specialty Pharmacy only; will include reasons for patient-reported missed doses
Measured: 12 months post switch to SC
Maintenance steroid use for IBD
Will determine if maintenance steroids were used for maintenance post switch to SC (yes/no)
Measured: 12 months post switch to SC
Number of steroid prescriptions for flares
Based on prescription history in patient chart
Measured: 12 months before and after switch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start16 Oct 2025
- Primary completion31 Mar 2026
- Study completion31 Dec 2026 (estimated)
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 Vanderbilt University Medical CenterThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda Pharmaceuticals U.S.A., Inc.
- Responsible party
- Principal investigator, Miranda Murray, Vanderbilt University Medical Center
- Investigators
- Miranda Z. Murray, PharmD, Principal investigator, Vanderbilt University Medical CenterAutumn D. Zuckerman, PharmD, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123350
- Sponsor's protocol ID
- 250579
- Status last verified
- May 2026
- First submitted
- 7 Aug 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Study does not meet the criteria for an Applicable Clinical Trial (ACT) under 42 CFR 11.22(b) as this study is not interventional (a clinical trial)
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolving Biologic Administration: Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07123350
- Acronym / sponsor ID
- 250579
- Keywords
- Inflammatory Bowel Disease, Health-system Specialty Pharmacy, Vedolizumab
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Takeda Pharmaceuticals U.S.A., Inc.
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Aug 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.
The goal of this retrospective study is to learn about dosing patterns in patients starting subcutaneous vedolizumab administration and patient outcomes after starting subcutaneous administration.
Patients with IBD who are starting subcutaneous vedolizumab administration between September 1, 2023, and March 31, 2025, as part of normal patient care, will be retrospectively reviewed and analyzed.
Detailed description
Vedolizumab intravenous (IV) infusions have been a first-line treatment option for patients with inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC) for over ten years. Recently, vedolizumab has been approved by the Food and Drug Administration for subcutaneous (SC) administration in the United States, offering patients a more convenient treatment option with medication administration at home. Evidence, largely from European countries where the SC formulation of vedolizumab has been available since 2020, shows a durable and potentially improved clinical response when switching to the SC formulation. A high SC treatment persistence has been found, mainly above 80%. Additionally, many patients accept the transition to SC vedolizumab as a safe and feasible treatment option and noting that the shorter treatment duration was specifically advantageous.
Current evidence is limited by the minimal amount of data on patients transitioning from IV to SC vedolizumab. For treatment with vedolizumab IV to SC, large scale, real-life studies with long term follow-up are necessary. More research is needed to further evaluate predictors for a relapse when transitioning from IV to SC therapy that have been seen in previous studies, including older age, escalated IV dosing, fecal calprotectin >250 microgram/gram at baseline, and CRP > 2g/L at baseline. We must also evaluate patient clinical outcomes after switching from IV to SC vedolizumab or infliximab and potential predictors for a positive response. These results will drive clinical decisions and further understanding of treatment expectations.
There is also a large gap in available information on standard and escalated dosing patterns before and after switching from IV to SC vedolizumab. Minimal research has evaluated whether or not patients on escalated IV dosing maintain escalated dosing at the time of switch or initiate standard SC dosing. There is a pressing need to understand dosing patterns in patients transitioning from escalated IV dosing to SC administration and patient outcomes after switching to SC administration based on dosing.
The proposed study would meet current gaps in literature by evaluating 1) clinical outcomes in patients with CD and UC switching from IV to SC vedolizumab and 2) dosing patterns from standard or escalated IV dosing at baseline to standard or escalated SC dosing, including switching practices and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV to SC switch | – | Drug: Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient carePatients with Crohn's Disease (CD) or Ulcerative Colitis (UC) referred to switch to subcutaneous vedolizumab from IV vedolizumab from a VUMC IBD provider and receive at least 1 dose of subcutaneous vedolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were identified if they were seen in the VUMC IBD clinic as part of normal clinical practice
Key inclusion criteria (2 listed)
- Patients with Crohn's Disease or Ulcerative Colitis referred to start SC vedolizumab from a VUMC IBD provider and receive at least 1 dose of subcutaneous vedolizumab
- Age 18 years old or older
Key exclusion criteria (2 listed)
- Patients prescribed SC vedolizumab from a non-VUMC provider
- Patients lost to follow-up or change in provider or medication before SC formulation started
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 |
|---|---|---|
| Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient careThis study does not include any subject enrollment or randomization. This is a retrospective cohort review of patients referred to start subcutaneous vedolizumab from a VUMC IBD provider. | Drug | IV to SC switch |
Primary outcome
Clinical Remission
Time frame: baseline with IV dosing, and 3, 6, 9, 12 months after switching to SC
Defined as clinical remission assessed and written by provider in the office visit note
9 secondary outcomes
Endoscopic Remission
Time frame: at baseline with IV dosing and within 12 months after switching to SC
Dosing patterns of IV dose/frequency and SC dose/frequency
Time frame: At baseline and up to 12 months after switching
SIBDQ score
Time frame: Baseline and 12 months post switch to SC
Persistence to SC formulation
Time frame: Up to 12 months after switching
Adverse events to vedolizumab SC
Time frame: Up to 12 months after switching
Adherence
Time frame: 12 months post switch to SC
Patient-reported missed doses
Time frame: 12 months post switch to SC
Maintenance steroid use for IBD
Time frame: 12 months post switch to SC
Number of steroid prescriptions for flares
Time frame: 12 months before and after switch
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. Study does not meet the criteria for an Applicable Clinical Trial (ACT) under 42 CFR 11.22(b) as this study is not interventional (a clinical trial)
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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.
Miranda Z. Murray, PharmD principal investigator
Vanderbilt University Medical Center
Autumn D. Zuckerman, PharmD study director
Vanderbilt University Medical Center
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 Inflammatory Bowel Disease (IBD) and Crohn&Amp;#39;s Disease (CD), run by Vanderbilt University Medical Center 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 8 May 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical Remission (time frame: baseline with IV dosing, and 3, 6, 9, 12 months after switching to SC). 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 8 May 2026.