Crohn DiseaseNCT04909359
Characterization of CD Responders to Vedolizumab
An observational study of Crohn Disease and Ulcerative Colitis, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2015to 18 May 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants being seen at the University of Miami IBD clinics with a diagnosis of CD or UC and about to initiate standard of care treatment with vedolizumab.
Who may be able to join
- Male or Female ≥18 and ≤70 years old.
- Patients must be appropriate for baseline colonoscopy prior to induction therapy with vedolizumab.
- Patients must have active inflammatory disease as seen by colonoscopy. 3A-Adult patients with moderately to severely active UC who have:
- had an inadequate response with, lost response to, or were;
- intolerant to a tumor necrosis factor (TNF) blocker or;
- immunomodulator; or had an inadequate response with, were;
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- intolerant to, or demonstrated dependence on corticosteroids:
- inducing and maintaining clinical response
- inducing and maintaining clinical remission
- improving endoscopic appearance of the mucosa
- achieving corticosteroid-free remission 3B-Adult patients with moderately to severely active CD who have
- <!-- -->
- had an inadequate response with, lost response to, or were
- intolerant to a TNF blocker or immunomodulator; or had an
- inadequate response with, were intolerant to, or demonstrated
- dependence on corticosteroids:
- achieving clinical response
- achieving clinical remission
- achieving corticosteroid-free remission
- Patients will also have biochemical analysis with CRP and fecal calprotectin prior to initiating treatment with vedolizumab.
Who cannot join
- Patients that will not undergo colonoscopy at baseline prior to treatment with vedolizumab.
- Patients who do not have endoscopic or biochemical (CRP, calprotectin) evidence of inflammation.
- Patients that have been on natalizumab within 12 weeks of beginning vedolizumab.
- Previous treatment with cyclosporine, thalidomide, or investigational drugs within 30 days of enrollment, prior treatment with vedolizumab
- Toxic megacolon
- Abdominal abscess
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- Symptomatic colonic stricture
- Stoma
- Increased risk of infection (eg, active or latent tuberculosis, immunodeficiency) Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunophenotypic Characterization of Crohn's Disease (CD) Responders to Vedolizumab
The purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy.
- Conditions
- Crohn Disease, Ulcerative Colitis
- Keywords
- Inflammatory Bowel Disease (IBD), IBD, CD, UC, Vedolizumab, VDZ, Biomarkers, Response
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease (CD) | People with CD recently receiving vedolizumab as standard of care will be followed up to 5 years. | |
| Ulcerative colitis (UC) | People with UC recently receiving vedolizumab as standard of care will be followed up to 5 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell concentration
Evaluated from peripheral blood samples and lamina propria biopsies
Measured: up to 22 weeks
Secondary outcomes (2)
Effector memory T cells concentration
Evaluated from peripheral blood samples and lamina propria biopsies
Measured: up to 22 weeks
T regulatory cells concentration
Evaluated from peripheral blood samples and lamina propria biopsies
Measured: up to 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start25 Aug 2015
- Primary completion15 May 2018
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Maria Abreu, University of Miami
- Investigators
- Maria T Abreu, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909359
- Sponsor's protocol ID
- 20150750
- Other IDs
- VEDO-IISR-2014-100892
- Status last verified
- May 2021
- First submitted
- 26 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunophenotypic Characterization of Crohn's Disease (CD) Responders to Vedolizumab
- ClinicalTrials.gov ID
- NCT04909359
- Acronym / sponsor ID
- 20150750
- Conditions
- Crohn Disease, Ulcerative Colitis
- Keywords
- Inflammatory Bowel Disease (IBD), IBD, CD, UC, Vedolizumab, VDZ, Biomarkers, Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 25 Aug 2015 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 1 Jun 2021 (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 purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease (CD) | – | –People with CD recently receiving vedolizumab as standard of care will be followed up to 5 years. |
| Ulcerative colitis (UC) | – | –People with UC recently receiving vedolizumab as standard of care will be followed up to 5 years. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants being seen at the University of Miami IBD clinics with a diagnosis of CD or UC and about to initiate standard of care treatment with vedolizumab.
Key inclusion criteria (20 listed)
- Male or Female ≥18 and ≤70 years old.
- Patients must be appropriate for baseline colonoscopy prior to induction therapy with vedolizumab.
- Patients must have active inflammatory disease as seen by colonoscopy. 3A-Adult patients with moderately to severely active UC who have:
- <!-- -->
- Patients will also have biochemical analysis with CRP and fecal calprotectin prior to initiating treatment with vedolizumab.
Key exclusion criteria (9 listed)
- Patients that will not undergo colonoscopy at baseline prior to treatment with vedolizumab.
- Patients who do not have endoscopic or biochemical (CRP, calprotectin) evidence of inflammation.
- Patients that have been on natalizumab within 12 weeks of beginning vedolizumab.
- Previous treatment with cyclosporine, thalidomide, or investigational drugs within 30 days of enrollment, prior treatment with vedolizumab
- Toxic megacolon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
T cell concentration
Time frame: up to 22 weeks
Evaluated from peripheral blood samples and lamina propria biopsies
2 secondary outcomes
Effector memory T cells concentration
Time frame: up to 22 weeks
T regulatory cells concentration
Time frame: up to 22 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Maria T Abreu, MD principal investigator
University of Miami
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 Crohn Disease and Ulcerative Colitis, run by University of Miami 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 20 inclusion and 9 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: finished, as of the sponsor's last update on 1 Jun 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
T cell concentration (time frame: up to 22 weeks). 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 1 Jun 2021.