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Vedolizumab for Crohn's Disease
Study Summary
This trial is exploring whether vedolizumab is an effective treatment for small bowel Crohn's disease, using MR enterography to measure response. They also hope to develop predictive models and identify biomarkers that correlate with vedolizumab's effectiveness, to help guide personalized treatment approaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 278 Patients • NCT03029143Trial Design
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Who is running the clinical trial?
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- I am under 18 years old.I am currently taking Vedolizumab, with or without thiopurines or methotrexate.I am scheduled for surgery before my first follow-up MRE.I have Crohn's disease affecting the area around my anus.My colon cancer affects parts other than the ascending colon and cecum.My inpatient scan was an MRE with good contrast and showed my small bowel clearly.I do not have kidney issues or implants that prevent me from having an MRE.My Crohn's disease affects only my small bowel or ileocecal area, confirmed by an MRE.I am 18 years old or older.
- Group 1: Vedolizumab 300 MG Injection [Entyvio]
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the maximum capacity of participants in this experiment?
"Indeed, the available information on clinicaltrials.gov establishes that this investigation is actively enrolling patients. This trial was first announced on June 8th 2018 and has been updated as recently as August 29th 2022. The research requires 80 participants from one location."
Has the FDA sanctioned the use of Vedolizumab 300 MG Injection [Entyvio]?
"We have assigned a score of 3 to the safety profile of Vedolizumab 300 MG Injection [Entyvio], as this is an approved Phase 4 trial."
Is this experiment actively recruiting participants?
"Affirmative. The information found on clinicaltrials.gov implicates that this medical experiment is currently enlisting patients. It was first published on June 8th 2018, and updated most recently on August 29th 2022, with the aim of enrolling 80 individuals from a single site."
Has any research like this been conducted before?
"Research into the effects of Vedolizumab 300 MG Injection [Entyvio] began in 2015. Funded by Takeda, a phase 1 trial involving 260 patients was conducted that year and eventually culminated in FDA approval. Currently, 23 distinct studies are being performed across 42 nations and 312 cities."
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