Crohn DiseasePhase 4NCT02820493
Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF
A Phase 4 study testing vedolizumab in people with Crohn Disease, run by Universita degli Studi di Genova.
Trial summary
Anti-cytokine antibodies, such as Infliximab (an anti TNF alfa chimeric antibody) and Adalimumab (an anti TNF alfa humanize antibody), have been developed and used in clinical practice for the treatment of patients with Crohn disease (CD). Unfortunately, their efficacy is limited. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- vedolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Mar 2019
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have given written informed consent to participate
- Be aged between 18 and 80
- Have a moderate/severe CD defined by an HBI >7 CD
Who cannot join
- previous treatment with anti-TNF drugs,
- concomitant use of immune-modulator drugs for CD (azathioprine/6-mercaptopurine, methotrexate)
- ulcerative colitis (UC) or inflammatory bowel disease undetermined (IBD-U) diagnosis
- symptomatic obstructive disease
- bowel resection within the past 6 months
- ileostomy
Show all 12Show fewer
- extensive small bowel resection (as determined by the investigator) or a short bowel syndrome
- patients who are currently receiving total parenteral nutrition
- history of cancer in the past 5 years
- pregnancy known at the study inclusion
- positive Clostridium difficile stool assay
- Listeria, human immunodeficiency virus, central nervous system demyelinating disease, untreated tuberculosis
About this study
Official title: Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression
Anti-cytokine antibodies, such as Infliximab (an anti TNF alfa chimeric antibody) and Adalimumab (an anti TNF alfa humanize antibody), have been developed and used in clinical practice for the treatment of patients with Crohn disease (CD). Unfortunately, their efficacy is limited. Based on these concepts, a new drug has been developed for IBD treatment. Vedolizumab (VDZ) is able to recognize the α4β7 heterodimer, and selectively blocks gut lymphocyte trafficking.
The hypothesis of this study is that VDZ therapy may be to halt CD disease progression during time and modifying its natural history, using Lemann Index.
Read the detailed description
All patients who will enter in the study will be follow-up at weeks 2-6-14-22-30-38-46 or before in case of relapse. A relapse will be defined by an Harvey Bradshaw Index ≥ 5 for 2 consecutive weeks. The following data are to be recorded:
- Physical examination
- Adverse Event Review
- Weight in Kg
- Full blood count
- Biochemical series including serum iron, serum ferritin, C reactive protein (PCR), ESR (eritrosedimatation rate)
- Fecal Calprotectin
- VDZ fecal loos
- VDZ trough levels and antidrug antibodies
- Current treatments
The last visit will be performed at week 54. The following data are to be recorded:
- Physical examination
- Adverse Event Review
- Weight in Kg
- Full blood count
- Biochemical series including serum iron, serum ferritin, C reactive protein (PCR), ESR (eritrosedimatation rate)
- Fecal Calprotectin
- VDZ fecal loos
- VDZ trough levels and antidrug antibodies
- Current treatments
- Routine lower and upper gastrointestinal endoscopy and magnetic resonance imaging or computed tomography of the small bowel
- SES-CD
- Lemann Index
- Conditions
- Crohn Disease
- Being tested
- vedolizumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vedolizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Other | Vedolizumab 300 mg iv at week 0, week 2 and week 6, than every 8 weeks. Receives: Drug: vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harvey Bradshaw index
Primary responders will defined as by a decrease of Harvey Bradshaw Index at week 14 of 3 point from the Harvey Bradshaw Index calculate at week 0.
Measured: Week 0-14
Secondary outcomes (4)
Lèmann Index
Measured: Week 0 and Week 54
VDZ trough levels
Measured: Week 0-2-6-14-22-30-38-46-54
anti-drug antibodies
Measured: Week 0-2-6-14-22-30-38-46-54
fecal VDZ loss
The investigators will evaluated the VDZ quantity (microgram) that a patients with mucosal ulcers could loss in patients feces.
Measured: Week 0-2-6-14-22-30-38-46-54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: Internal problems
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgia Bodini, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820493
- Sponsor's protocol ID
- EVeA Study
- Status last verified
- May 2018
- First submitted
- 17 May 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression
- ClinicalTrials.gov ID
- NCT02820493
- Acronym / sponsor ID
- EVeA Study
- Conditions
- Crohn Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- 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.
Anti-cytokine antibodies, such as Infliximab (an anti TNF alfa chimeric antibody) and Adalimumab (an anti TNF alfa humanize antibody), have been developed and used in clinical practice for the treatment of patients with Crohn disease (CD). Unfortunately, their efficacy is limited. Based on these concepts, a new drug has been developed for IBD treatment. Vedolizumab (VDZ) is able to recognize the α4β7 heterodimer, and selectively blocks gut lymphocyte trafficking.
The hypothesis of this study is that VDZ therapy may be to halt CD disease progression during time and modifying its natural history, using Lemann Index.
Detailed description
All patients who will enter in the study will be follow-up at weeks 2-6-14-22-30-38-46 or before in case of relapse. A relapse will be defined by an Harvey Bradshaw Index ≥ 5 for 2 consecutive weeks. The following data are to be recorded:
- Physical examination
- Adverse Event Review
- Weight in Kg
- Full blood count
- Biochemical series including serum iron, serum ferritin, C reactive protein (PCR), ESR (eritrosedimatation rate)
- Fecal Calprotectin
- VDZ fecal loos
- VDZ trough levels and antidrug antibodies
- Current treatments
The last visit will be performed at week 54. The following data are to be recorded:
- Physical examination
- Adverse Event Review
- Weight in Kg
- Full blood count
- Biochemical series including serum iron, serum ferritin, C reactive protein (PCR), ESR (eritrosedimatation rate)
- Fecal Calprotectin
- VDZ fecal loos
- VDZ trough levels and antidrug antibodies
- Current treatments
- Routine lower and upper gastrointestinal endoscopy and magnetic resonance imaging or computed tomography of the small bowel
- SES-CD
- Lemann Index
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Other | Drug: vedolizumabVedolizumab 300 mg iv at week 0, week 2 and week 6, than every 8 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have given written informed consent to participate
- Be aged between 18 and 80
- Have a moderate/severe CD defined by an HBI >7 CD
Key exclusion criteria (12 listed)
- previous treatment with anti-TNF drugs,
- concomitant use of immune-modulator drugs for CD (azathioprine/6-mercaptopurine, methotrexate)
- ulcerative colitis (UC) or inflammatory bowel disease undetermined (IBD-U) diagnosis
- symptomatic obstructive disease
- bowel resection within the past 6 months
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 |
|---|---|---|
| vedolizumab | Drug | single arm study |
Primary outcome
Harvey Bradshaw index
Time frame: Week 0-14
Primary responders will defined as by a decrease of Harvey Bradshaw Index at week 14 of 3 point from the Harvey Bradshaw Index calculate at week 0.
4 secondary outcomes
Lèmann Index
Time frame: Week 0 and Week 54
VDZ trough levels
Time frame: Week 0-2-6-14-22-30-38-46-54
anti-drug antibodies
Time frame: Week 0-2-6-14-22-30-38-46-54
fecal VDZ loss
Time frame: Week 0-2-6-14-22-30-38-46-54
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vedolizumab in people with Crohn Disease, run by Universita degli Studi di Genova.
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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Harvey Bradshaw index (time frame: Week 0-14). 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 14 May 2018.