ASSESSMENT OF THE PERFORMANCE OF THE SECOND GENERATION PILLCAM COLON CAPSULE (PCCE 2) IN CROHN*S DISEASE, BEFORE AND AFTER TREATMENT WITH ANTI-TNF AGENTS OR VEDOLIZUMAB : SENSITIVITY TO CHANGE STUDY

Completed

Conditions: Crohn's disease
Inflammatory bowel disease
10017969

Registration Number: NL-OMON50462

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 27

Inclusion Criteria

Active ileocolonic Crohn's disease with CDAI > 150
Elevated faecal calprotectin >250 ug/g and /or increased CRP levels(>5mg/l)
and/ or endoscopy showing ulcerations <3 months prior to screening without any
change in treatment, regardless of biomarkers.

Abdominal imaging clinically indicated in order to determine disease activity
before embarking on anti-TNF or vedolizumab treatment

Exclusion Criteria

Any contraindication for colon capsule examination including swallowing
disorders, severe congestive heart failure, renal insufficiency or co-morbities
contraindicating these procedures.
More than 1 bowel resection for CD
Previous subtotal or total colectomy
Active (draining) fistulas
Known small bowel strictures
Short bowel syndrome or stoma
High suspicion of small bowel strictures.
Pacemaker or ICD

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Examine sensitivity and specificity of the PCCE2(Pillcam) to detect mucosal<br /><br>healing in Crohn's patients before and after treatment with Infliximab or<br /><br>Adalimumab or Vedolizumab.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Safety and tolerability of the preparation procedure and the Pillcam<br /><br>examination<br /><br>2. Determine inter-observer variability by serial readings of Pillcam<br /><br>recordings</p><br>