Trial · NCT07123350
Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease
NCT07123350, Active not recruiting, Vanderbilt University Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease. Trials, record NCT07123350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07123350
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating the Shift From Intravenous to Subcutaneous Vedolizumab for Inflammatory Bowel Disease
- NCT number
- NCT07123350
- Status
- Active not recruiting
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Inflammatory Bowel Disease (IBD), Crohn&Amp;#39;s Disease (CD), Ulcerative Colitis (UC)
- Interventions
- Patient switched from IV vedolizumab to subcutaneous vedolizumab as part of normal patient care
- First posted
- 2025-08-14
- Last updated
- 2026-05-08
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Remission | 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 |
| Secondary | Endoscopic Remission | at baseline with IV dosing and within 12 months after switching to SC | Endoscopic remission as seen by provider after colonoscopy assessment |
| Secondary | Dosing patterns of IV dose/frequency and SC dose/frequency | At baseline and up to 12 months after switching | standard dosing vs escalated dosing; includes any dose changes of the SC product within 12 months after switching from IV to SC |
| Secondary | SIBDQ score | Baseline and 12 months post switch to SC | 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). |
| Secondary | Persistence to SC formulation | Up to 12 months after switching | Measured by time to discontinuation; will include reason for discontinuation if SC stopped |
| Secondary | Adverse events to vedolizumab SC | Up to 12 months after switching | Adverse events to vedolizumab SC that required change back to IV |
| Secondary | Adherence | 12 months post switch to SC | Measured by PDC |
| Secondary | Patient-reported missed doses | 12 months post switch to SC | For patients filling with Vanderbilt Specialty Pharmacy only; will include reasons for patient-reported missed doses |
| Secondary | Maintenance steroid use for IBD | 12 months post switch to SC | Will determine if maintenance steroids were used for maintenance post switch to SC (yes/no) |
| Secondary | Number of steroid prescriptions for flares | 12 months before and after switch | Based on prescription history in patient chart |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07123350
GET https://conductscience.org/api/trials/v1/NCT07123350/registered