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This study will examine the safety and effectiveness of extracorporeal photopheresis (ECP) in controlling Crohn's disease symptoms as patients taper their corticosteroid dose. Crohn's disease is a chronic inflammatory bowel disease. Patients commonly have chronic diarrhea with abdominal pain, loss of appetite and weight loss. Acute disease flares are treated with large doses of corticosteroids, but long-term use of these drugs can have harmful side effects. ECP (described below), is approved to treat skin symptoms associated with a type of cancer called cutaneous T-cell lymphoma and has been used experimentally in conditions involving abnormal inflammation.
Patients 18 years of age and older who have had Crohn's disease for at least 6 months, who are corticosteroid-dependent, and whose symptoms are controlled well enough so that their Crohn's Disease Activity Index (CDAI) is less than 220, may be eligible for this study. Candidates will be screened with a medical history and review of medical records, physical examination, electrocardiogram, blood tests, urine pregnancy test for women of childbearing potential, and a questionnaire about how Crohn's disease affects their life and activities.
Patients with a CDAI score of less than 150 will begin ECP treatments as soon as possible. Those with scores from 150 to 219 will have their corticosteroid dose increased enough to bring their CDAI score to below 150 before beginning ECP. Patients who do not achieve a CDAI of less than 150 after 4 to 6 weeks of increased corticosteroids will be excluded from the study.
Participants will have ECP treatments for 2 consecutive days every 2 weeks for 24 weeks, for a total of 26 treatments. For ECP, patients undergo leukapheresis, a method of collecting large numbers of white blood cells, or leukocytes-cells that may be responsible for many of the medical problems in Crohn's disease. Whole blood is collected through a needle in an arm vein, similar to donating a unit of blood. The blood flows through a machine that separates it into its components by spinning. The white cells are removed and collected in a plastic bag, and the red blood cells and plasma are returned to the patient's bloodstream through the same needle. The collected white cells are mixed with a drug called UVADEX® (Registered Trademark), exposed to ultraviolet (UVA) light, and then returned to the patients' bloodstream. (The UVADEX allows the blood cells to absorb more UVA.) The UVA changes the cells in a way that, once they are back in the body, they cause changes in other cells like them. Each ECP treatment takes 3 to 4 hours. On the first day of each 2-day treatment, patients will undergo a review of symptoms, check of vital signs, and blood draw. They will complete a CDAI diary for 7 days before the first of the two ECP treatments and a questionnaire about their life and activities at 4-week intervals. During the ECP treatment period, corticosteroids will be slowly reduced as long as disease symptoms do not worsen.
Patients whose disease remains under control with cessation of all steroids may begin maintenance ECP, 2 days in a row every 4 weeks for an additional 20 weeks (another 10 treatments), with the same follow-up as described above, and a full physical examination 4 weeks after the final treatment. Patients who were able to reduce, but not stop, steroid treatment may be considered for maintenance therapy if it is thought that continuing treatment may enable further reduction of steroids. Patients whose disease symptoms worsen with ECP or who have not been able to decrease their steroid dose will not be eligible for maintenance therapy and their participation in the study will end.
This protocol aims to measure the safety and effectiveness of extracorporeal photopheresis (ECP) therapy for maintaining remission of symptoms during withdrawal of corticosteroids from patients with steroid-dependent Crohn's disease. Potential subjects will be asymptomatic or have a low level of symptoms that respond to an increase in their steroid dose; furthermore potential subjects will be dependent on steroids to control their symptoms and have a history of failing other immunosuppressive drugs to control their symptoms.
This is an unblinded, single-arm study of ECP in Crohn's disease. This trial will use ECP twice a week every two weeks over 24 weeks during which time the dose of corticosteroids will be tapered. If the corticosteroids are able to be withdrawn without an increase in symptoms, then subjects may be eligible for further ECP (twice a week every four weeks over 24 weeks) as a maintenance regimen.
Outcome parameters include the rates of complete and partial steroid tapering while maintaining remission, the rates of adverse events, and secondary clinical outcomes such as duration of response, rate of and time to relapse, and changes in symptom index scores. In addition, the NIH will perform a substudy that includes serial colonoscopy to measure cytokine and cell population changes in mononuclear cells extracted from biopsies.
The long-term goals of this study are to test the safety and efficacy of ECP as a steroid-sparing and remittive therapy in Crohn's disease, to determine the immune response it effects in the gut mucosa, and identify factors associated with responders versus non-responders to ECP.
Endpoint Classification: Safety Study, Primary Purpose: Treatment
UVADEX and UVAR XTS Photopheresis System
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2014-07-23T21:52:29-0400
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Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.
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