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

Status Withdrawn

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Crohn Disease

• NCT number: NCT02820493
• Study type: Interventional
• Source: Universita degli Studi di Genova
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 2016
• Completion date: March 2019