Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Local Ileal Delivery, Delayed-Release Formulations, 6-Mercaptopurine, Calcitriol
Eligibility Criteria
Inclusion Criteria: Male or Female patients, aged 18-75 years with moderate Crohn's Disease (CDAI score >=220 and <=400 at screening), with or without adjunctive mesalamine treatment, 12 with involvement of the ileum and three without ileal involvement Definitive diagnosis of active inflammatory CD with fibrostenosing and/or fistulizing/perforating CD types ruled out based on clinical and radiological or endoscopic or pathological findings, within the previous 6 months Exclusion Criteria: Body weight below 42.5 kg Subjects who have received either methotrexate, cyclosporine or anti-TNFalpha (infliximab, Remicade), anti-integrin (namixilab) in the past 3 months Subjects who are taking allopurinol, sulfasalazine, valerian, warfarin and corticosteroids,including budesonide and prednisone within 28 days prior to and throughout the study Previous bowel resection, including prior colostomy, ileostomy or colectomy with ileorectal anastomosis Symptomatic stenosis or ileal strictures; x-ray evidence of fibrosed bowel Subjects with ulcerative colitis or short bowel syndrome Subjects who present with, or with a history of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed or abdominal abscess or infection, toxic megacolon Subjects with fistulizing CD or isolated small bowel CD Subjects with evidence of other serious infectious, autoimmune, hepatic,nephritic or systemic disease or compromised organ function Subjects with a history of GI tract malignancy or IBD-associated malignant changes in the intestines
Sites / Locations
- Hadassah Medical Center