Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF
Primary Purpose
Crohn Disease
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
vedolizumab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility Criteria
Inclusion Criteria:
- Have given written informed consent to participate
- Be aged between 18 and 80
- Have a moderate/severe CD defined by an HBI >7 CD
Exclusion Criteria:
- 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
- pregnancy known at the study inclusion
- positive Clostridium difficile stool assay
- Listeria, human immunodeficiency virus, central nervous system demyelinating disease, untreated tuberculosis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single arm study
Arm Description
Vedolizumab 300 mg iv at week 0, week 2 and week 6, than every 8 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Lèmann Index
VDZ trough levels
anti-drug antibodies
fecal VDZ loss
The investigators will evaluated the VDZ quantity (microgram) that a patients with mucosal ulcers could loss in patients feces.
Full Information
NCT ID
NCT02820493
First Posted
May 17, 2016
Last Updated
May 7, 2018
Sponsor
Universita degli Studi di Genova
1. Study Identification
Unique Protocol Identification Number
NCT02820493
Brief Title
Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF
Official Title
Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Internal problems
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita degli Studi di Genova
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm study
Arm Type
Other
Arm Description
Vedolizumab 300 mg iv at week 0, week 2 and week 6, than every 8 weeks.
Intervention Type
Drug
Intervention Name(s)
vedolizumab
Primary Outcome Measure Information:
Title
Harvey Bradshaw index
Description
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.
Time Frame
Week 0-14
Secondary Outcome Measure Information:
Title
Lèmann Index
Time Frame
Week 0 and Week 54
Title
VDZ trough levels
Time Frame
Week 0-2-6-14-22-30-38-46-54
Title
anti-drug antibodies
Time Frame
Week 0-2-6-14-22-30-38-46-54
Title
fecal VDZ loss
Description
The investigators will evaluated the VDZ quantity (microgram) that a patients with mucosal ulcers could loss in patients feces.
Time Frame
Week 0-2-6-14-22-30-38-46-54
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have given written informed consent to participate
Be aged between 18 and 80
Have a moderate/severe CD defined by an HBI >7 CD
Exclusion Criteria:
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
pregnancy known at the study inclusion
positive Clostridium difficile stool assay
Listeria, human immunodeficiency virus, central nervous system demyelinating disease, untreated tuberculosis
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF
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