A RANDOMIZED, PROSPECTIVE, DOUBLE-BLINDED, PLACEBO-CONTROLLED ( SHAM-CONTROLLED

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study involves research to evaluate the potential benefits and safety of repeated treatment with the Adacolumn Apheresis System. Once the study doctor has determined that a subject is eligible for participation, they will be asked to review and sign a consent form. The study doctor will then confirm eligibility by obtaining a complete medical history, current medication use, collecting blood, urine, and stool samples, conducting complete physical exam and flexible proctosigmoidoscopy. Patients will receive a 5-15 minute trial of the apheresis to establish that there is good venous access. Subjects will then be randomized to receive either Adacolumn or placebo treatment. In the Adacolumn arm the blood will pass through the Adacolumn. In the placebo treatment, blood will go around the Adacolumn through a plastic line. Subjects receive a total of 10 apheresis treatments: 2 times a week for the first 2 weeks and then once a week for 6 more weeks. Subjects will be evaluated for response at week 12 after which they will enter into a follow-up program in which subjects will be followed every 4 weeks to assess disease activity until week 24. Throughout the study subjects will fill out questionnaires to assess quality of life and physical and lab evaluations (blood and urine ) will be done to monitor effectiveness and safety of treatment. A sigmoidoscopy will be performed twice during the study. There will be no racial or ethnic limitations for enrollment. The following individuals will, however, be excluded as they represent vulnerable populations: patients under 18 years, pregnant women, and women of reproductive potential who don t agree to use birth control throughout the study. Subjects enrolled in the study will be identified by initials and 5 digit subject ID numbers which will be linked to the patient s names in a password protected computer file.