Imaging study in patients with Crohn`s Disease

• Conditions: Investigation of magnetic resonance enterography (MRE) with/without dye for evaluation of disease status in Crohn's disease; MedDRA version: 14.1Level: HLGTClassification code 10017969Term: Gastrointestinal inflammatory conditionsSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2012-000729-28-ES
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-17
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

- Signed Informed Consent Form
- Age >or= 18 years
- Confirmed histologic diagnosis of CD and a disease duration of >or= 12 weeks (after first diagnosis by a physician)
- Clinical indication for the performance of MRE, with or without contrast
- On a stable dose of medication for CD for a defined period of time prior
to study entry, as outlined below:
- Stable dose of 5-aminosalicylic acid preparations (oral or rectal)
for 4 weeks prior to Day 1
- Stable dose of corticosteroid medication (oral or rectal) for 2 weeks prior to Day 1
- Stable dose of immunosuppressive therapy (6-mercaptopurine,
azathioprine, or methotrexate) for 3 months prior to Day 1
- Stable dose of anti-TNF therapy for 8 weeks prior to Day 1
- CDAI score within pre-specified range
- Estimated GFR >or= 30-60 mL/min/1.73 m2, as estimated from serum
creatinine levels
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Requirement for hospitalization due to severity of CD
- Inability to comply with study protocol
- Lack of peripheral venous access
- Contraindications to MRI, including non?MRI-compatible medical or dental implants, other ferromagnetic metal objects in the body, severe
claustrophobia, very large tattoos, inability to lie still in a supine position
for up to 40 minutes, or inability to meet local imaging site MRI eligibility
requirements based on safety screening procedures
- Pregnant or lactating
- Significant uncontrolled disease, such as cardiac, pulmonary, renal, hepatic, endocrine, neurological, gastrointestinal, or hematologic disorders, that would contraindicate an ileocolonoscopy or MRE scan
- Distal colonic strictures on ileocolonoscopy that prevent traverse of
the colonoscope
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to imaging contrast agents
- Clear symptoms of bowel obstruction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified