Crohn DiseaseNCT03889613
Pillcam Crohn's Capsule for Monitoring of Panenteric Mucosal Healing in Crohn's Disease Patients With Vedolizumab
A study testing prospective follow-up with videocapsule in people with Crohn Disease, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- prospective follow-up with videocapsule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Apr 2019to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- History of small bowel radiation
- History of previous capsule retention
- Previous treatment with vedolizumab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pillcam Crohn's Capsule for Monitoring of Pan Enteric Mucosal Healing in Crohn's Disease Patients Treated With Vedolizumab
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
Read the detailed 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.
- Conditions
- Crohn Disease
- Being tested
- prospective follow-up with videocapsule
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective follow-up with videocapsuleOther
prospective follow-up with videocapsule
| Study group | Role | What they receive |
|---|---|---|
| all patients | Experimental | All enrolled patients- prospective observation (all patients are followed using videocapsule) Receives: Other: prospective follow-up with videocapsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start3 Apr 2019
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The patients are started on vedolizumab and are prospectively followed by capsule. There is no predefined intervention that stems from diagnostic observations
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889613
- Sponsor's protocol ID
- SHEBA-18-4710-UK-CTIL
- Status last verified
- Dec 2023
- First submitted
- 17 Mar 2019
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pillcam Crohn's Capsule for Monitoring of Pan Enteric Mucosal Healing in Crohn's Disease Patients Treated With Vedolizumab
- ClinicalTrials.gov ID
- NCT03889613
- Acronym / sponsor ID
- SHEBA-18-4710-UK-CTIL
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Takeda, Medtronic
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patients are started on vedolizumab and are prospectively followed by capsule. There is no predefined intervention that stems from diagnostic observations
| Arm | Type | Receives |
|---|---|---|
| all patients | Experimental | Other: prospective follow-up with videocapsuleAll enrolled patients- prospective observation (all patients are followed using videocapsule) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- History of small bowel radiation
- History of previous capsule retention
- Previous treatment with vedolizumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prospective follow-up with videocapsuleprospective follow-up with videocapsule | Other | all patients |
Primary outcome
Panenteric mucosal healing
Time frame: 52 weeks
Percentage of patients achieving pan enteric mucosal healing at week 52 post VDZ initiation as assessed by the Pillcam Crohn's capsule
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prospective follow-up with videocapsule in people with Crohn Disease, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Panenteric mucosal healing (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.