Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-05 @ 2:51 PM
Study NCT ID:
NCT02820493
Status:
WITHDRAWN
Last Update Posted:
2018-05-14
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Vedolizumab in CD Patients Naïve to Anti-TNF
Sponsor:
Universita degli Studi di Genova
Organization:
Study Overview
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WITHDRAWN
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Internal problems
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: