Study Stopped
Internal problems
Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF
Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2016
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
July 1, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 14, 2018
May 1, 2018
2.5 years
May 17, 2016
May 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Week 0-14
Secondary Outcomes (4)
Lèmann Index
Week 0 and Week 54
VDZ trough levels
Week 0-2-6-14-22-30-38-46-54
anti-drug antibodies
Week 0-2-6-14-22-30-38-46-54
fecal VDZ loss
Week 0-2-6-14-22-30-38-46-54
Study Arms (1)
single arm study
OTHERVedolizumab 300 mg iv at week 0, week 2 and week 6, than every 8 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Have given written informed consent to participate
- Be aged between 18 and 80
- Have a moderate/severe CD defined by an HBI \>7 CD
You may not qualify if:
- 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
- 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
- positive Clostridium difficile stool assay
- Listeria, human immunodeficiency virus, central nervous system demyelinating disease, untreated tuberculosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 17, 2016
First Posted
July 1, 2016
Study Start
September 1, 2016
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
May 14, 2018
Record last verified: 2018-05