Protocol Number: 08-I-0063
Patients 18 to 70 years of age with Crohn's disease that is not well controlled with standard treatment may be eligible for this study. Participants are randomly assigned to one of three study groups to receive either a high dose of Prochymal[TM], a low dose of Prochymal[TM] or placebo. The study medications are given as four separate intravenous (through a vein) infusions over 2 weeks (study days 0 to 14). Each infusion takes between 60 and 75 minutes. During the first four weeks of the study patients have four physical examinations and two fistula assessments. They complete several inflammatory bowel disease questionnaires (IBDQ) and fill out symptoms diaries to calculate their Crohn's disease activity index (CDAI). Patients are followed for 2 years with six clinic visits on study days 28, 42, 56, 84, months 12 and 24 for the following procedures: -Medical history, physical examination, blood tests, review of medicines taken - all visits -Urine and stool tests, fistula assessment, IBDQ and CDAI - days 28, 42, 56, 84 -CT scans of chest, abdomen and pelvis - months 12 and 24 Patients whose symptoms improved during the treatment phase (days 0-28) but subsequently worsened may receive up to two more treatment cycles with Prochymal[TM] (four infusions each cycle). Patients may also participate in a sub-study to learn how immune cells and proteins they release called cytokines react to Prochymal[TM] infusions. For this sub-study, patients have the following procedures: -Blood tests -Colonoscopy and biopsy. For this test, the patient is given a sedative. A long, flexible, lighted tube is inserted into the rectum and slowly guided into the colon to examine for inflammation. In addition, a small tissue sample is collected during the procedure for laboratory testing.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
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