Clinical trial NCT02820493: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Crohn Disease
Lead sponsor: Universita degli Studi di Genova
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

1. Physical examination
2. Adverse Event Review
3. Weight in Kg
4. Full blood count
5. Biochemical series including serum iron, serum ferritin, C reactive protein (PCR), ESR (eritrosedimatation rate)
6. Fecal Calprotectin
7. VDZ fecal loos
8. VDZ trough levels and antidrug antibodies
9. Current treatments

The last visit will be performed at week 54. The following data are to be recorded:

1. Physical examination
2. Adverse Event Review
3. Weight in Kg
4. Full blood count
5. Biochemical series including serum iron, serum ferritin, C reactive protein (PCR), ESR (eritrosedimatation rate)
6. Fecal Calprotectin
7. VDZ fecal loos
8. VDZ trough levels and antidrug antibodies
9. Current treatments
10. Routine lower and upper gastrointestinal endoscopy and magnetic resonance imaging or computed tomography of the small bowel
11. SES-CD
12. Lemann Index

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

Primary outcomes:
measure: Harvey Bradshaw index
timeFrame: Week 0-14
Secondary outcomes:
measure: Lèmann Index
timeFrame: Week 0 and Week 54
measure: VDZ trough levels
timeFrame: Week 0-2-6-14-22-30-38-46-54
measure: anti-drug antibodies
timeFrame: Week 0-2-6-14-22-30-38-46-54
measure: fecal VDZ loss
timeFrame: Week 0-2-6-14-22-30-38-46-54
Other outcomes:
Locations:
Study officials:
References: