Pillcam Crohn's Capsule for Monitoring of Panenteric Mucosal Healing in Crohn's Disease Patients With Vedolizumab

NCT03889613 | Unknown

• 1 other identifier: SHEBA-18-4710-UK-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Panenteric mucosal healing

  Percentage of patients achieving pan enteric mucosal healing at week 52 post VDZ initiation as assessed by the Pillcam Crohn's capsule

  52 weeks

Study Arms (1)

all patients

EXPERIMENTAL

All enrolled patients- prospective observation (all patients are followed using videocapsule)

Other: prospective follow-up with videocapsule

Interventions

prospective follow-up with videocapsule OTHER

prospective follow-up with videocapsule

all patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Crohn's disease
• planned to initiate VDZ treatment as recommended by the treating physician
• age- 18-70
• active small bowel inflammation on SBC (LS ≥ 220 or SES-CD\>5 or active inflammation on the Pillcam Crohn's capsule score and FC\>100 mg/kg)

You may not qualify if:

• History of small bowel radiation
• History of previous capsule retention
• Previous treatment with vedolizumab

Sponsors & Collaborators

• Sheba Medical Center: lead
• Takeda: collaborator
• Medtronic: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The patients are started on vedolizumab and are prospectively followed by capsule. There is no predefined intervention that stems from diagnostic observations

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 26, 2019
• Study Start: April 3, 2019
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)