Trial · NCT07123350
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| Other | Hospitalization and ED visits related to IBD | 12 months before and after switch to SC | Determined based on visits documented in patient chart |
| Other | Adverse events reported after switching to SC | 12 months post switch to SC | Will only be assessed for patients filling with Vanderbilt Specialty Pharmacy |
| Other | Drug trough levels before and after switching to SC | 12 months before and after switching to SC | Vedolizumab trough levels |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07123350/registered