Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF

Crohn Disease Clinical Trial

Official title:

Effectiveness of Vedolizumab Therapy in Inducing Clinical Remission in CD Patients Naïve to Anti-TNF and Its Capability to Halt Disease Progression

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02820493
• Other study ID #: EVeA Study
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: March 2019

Study information

• Verified date: May 2018
• Source: Universita degli Studi di Genova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• vedolizumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universita degli Studi di Genova

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lèmann Index		Week 0 and Week 54
Secondary	VDZ trough levels		Week 0-2-6-14-22-30-38-46-54
Secondary	anti-drug antibodies		Week 0-2-6-14-22-30-38-46-54
Secondary	fecal VDZ loss	The investigators will evaluated the VDZ quantity (microgram) that a patients with mucosal ulcers could loss in patients feces.	Week 0-2-6-14-22-30-38-46-54