Investigation of magnetic resonance enterography (MRE) with/without dye for evaluation of disease status in Crohn's disease MedDRA version: 14.1 Level: HLGT Classification code 10017969 Term: Gastrointestinal inflammatory conditions System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: /
Product Code: /
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ÁCIDO GADOBÉNICO
CAS Number: 113662-23-0
Current Sponsor code: NA
Other descriptive name: NA
Concentrat
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the test-retest reliability (precision) of MRE assessments of CD activity in the small bowel in a global setting;Secondary Objective: - To establish the correlation between MRE and ileocolonoscopy as an assessment of CD activity in the colon in a global setting - To assess the impact of the use of colonic contrast on MRE assessment of CD activity in the colon - To establish a standardized CD MRE technical protocol that is feasible to use in a global setting - To confirm that high-quality MRE data can be obtained across six investigational sites;Primary end point(s): The outcome measures for this study are as follows: - MRE-derived MaRIA scores from small bowel and colon segments - Compliance with the MRE technical protocol for patient preparation and scanning, as specified in the imaging review charter - MRE image quality, as specified in the imaging review charter - Ileocolonoscopy-derived CDEIS score and SES CD - CDAI score - Serum or plasma biomarkers, including but not limited to C-reactive protein;Timepoint(s) of evaluation of this end point: As Necessary | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Belgium, France, Spain, United States
Contacts
Public ContactMedical Monitor
Genentech, Inc.
Outcome results
None listed