Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF

NCT ID: NCT02820493

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-03-31

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

Conditions

Crohn Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm study

Vedolizumab 300 mg iv at week 0, week 2 and week 6, than every 8 weeks.

Group Type: OTHER

vedolizumab

Intervention Type: DRUG

Interventions

vedolizumab

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita degli Studi di Genova

OTHER

Sponsor Role: lead

Responsible Party

Giorgia Bodini

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EVeA Study

Identifier Type: -

Identifier Source: org_study_id