MULTICENTER STUDY IN PATIENTS WITH CROHN?S DISEASE FOR CHARACTERIZATION OF MAGNETIC RESONANCE ENTEROGRAPHY ASSAYS FOR ASSESSMENT OF DISEASE ACTIVITY

Genentech, Inc.0 个研究点目标入组 54 人开始时间: 2012年4月17日最近更新: 2012年6月26日

适应症

试验速览

暂无简介。

•- 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

•- 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

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