Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03889613 |
| Other study ID # |
SHEBA-18-4710-UK-CTIL |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 3, 2019 |
| Est. completion date |
November 1, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
Sheba Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The main aim of the study is to evaluate the lielihood of panenteric mucosal healing in
Crohn's disease patients treated with vedolizumab The study will include patients with active
Crohn's disease who are starting treatment with vedolizumab. The patients will undergo
evaluation with panenteric capsule endoscopy, intestinal ultrasound and inflammatory
biomarkers before treatment onset, at week 14 and week 52
Description:
Mucosal healing has been widely accepted as the ultimate therapeutic goal in treatment of IBD
patients and is associated with improved short and long-term outcomes in both ulcerative
colitis and Crohn's disease (CD). However, the vast majority of the available clinical data
pertains to colonic mucosal healing. In CD, the small bowel is involved in at least 75% of
the patients, frequently in locations that are not accessible to ileocolonoscopy Active small
bowel disease can be detected in at least 50% of CD patients in clinical remission[3].
Moreover, colonic and small bowel mucosal healing do not parallel each other, and it is quite
common to detect inflammation in one segment while the other demonstrates endoscopically
active disease.
Small bowel capsule endoscopy (SBCE) is the prime modality for evaluation of the entire small
bowel[5]. It provides a safe and accurate way to screen and evaluate the entire small bowel,
using a clinically validated endoscopic score such as the Lewis score (LS). Several studies
evaluated the use of SBCE in monitoring mucosal healing in Crohn's disease, in both active
and quiescent disease. The safety profile of SBCE in CD is excellent, especially after
verification of small bowel patency using a patency capsule (PC).
To date, prospective data pertaining to the efficacy of biologics in induction of small bowel
mucosal healing is very limited. The only prospective study to date was relatively small (36
patients) and demonstrated a significant improvement in mucosal inflammation and achievement
of mucosal healing in patients that received Adalimumab and were evaluated with SBCE at week
0, 12 and 52 The rate of mucosal healing increased significantly from week 12 to 54.. No such
data exists for other biologics. Recently, a combined pan-enteric capsule (PillCam Crohn's
capsule) was developed by Medtronic. The capsule is based on an existing PillCam Colon 2 with
a modified reading software. This capsule enables evaluation of mucosal inflammation and
healing in the entire digestive tract in a single safe and non-invasive procedure. The new
software of Rapid 9 includes a new method of describing the inflammatory burden on each of
the 3 tertiles of the small bowel and two of the colon as well as the "old" Lewis score. In a
feasibility 5 center prospective trial the capsule exited the colon while photographing in
83% of patients and reached the recto-sigma in 95%.
Intestinal ultrasound (IUS) is an accurate, safe and cheap modality for bedside evaluation of
the small bowel. It was evaluated for both diagnosis and monitoring of intestinal
inflammation in CD, and can be also utilized to assess the response to treatment. Recently, a
quantitative score (Limberg index (LI)) for quantification of small bowel inflammation on IUS
was validated.
The aim of our study is to assess the utility of the Pillcam Crohn's capsule in assessment of
panenteric mucosal healing in CD patients treated with vedolizumab Study interventions
Visit 1 (before vedolizumab is started):
- Clinical activity
- Patients will perform patency capsule (PC) and give fecal sample for FC and microbiome.
- If PC is safely excreted within 30 hours and FC > 100 mg/kg, the patient will undergo
SBC and will be enrolled if LS ≥ 220 or CDEIS>5.
- Blood will be drawn for measurement of CRP levels and complete blood count (CBC).
- IUS will be performed. Second visit and third visit(week 14 and 52): will include
clinical evaluation, CBC, CRP, FCP, microbiome, SBC and IUS.
