Protocol Number: 05-I-0108

Title:

A Multicenter, Open-Label, Study of Extracorporeal Photoimmune Therapy with UVADEX in the Treatment of Patients with Moderately Active Crohn's Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents

Number:

05-I-0108

Summary:

This multi-center study will evaluate the safety and effectiveness of extracorporeal photopheresis (ECP) for treating Crohn's disease symptoms. ECP is a procedure in which white blood cells are collected by leukapheresis (see below) and treated with ultraviolet A (UVA) light (a wavelength invisible to the human eye) in a process called photopheresis. The treated cells are returned to the body, where they cause changes in other similar cells. ECP is approved for treating skin symptoms in cutaneous T-cell lymphoma (cancer of white blood cells called lymphocytes), and it has been used experimentally in other conditions where white cells are involved in abnormal inflammation. In a previous preliminary study of, 8 of 10 Crohn's patients treated with ECP were able to stop taking steroids while keeping their symptoms under control. This study will assess this treatment in a larger number of patients.

Patients 18 years of age and older who have had Crohn's disease for at least 6 months, have failed treatment with immunosuppressants, are taking corticosteroids, have active symptoms, are not pregnant, and weigh at least 40 kg (88 pounds) may be eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, blood tests, and urine pregnancy test for women who can bear children. Candidates also complete a 32-item questionnaire about how Crohn's disease affects their life and activities and fill out diary cards measuring the severity of their symptoms for 7 days.

Participants have ECP treatments 2 consecutive days each week during study weeks 0-4, and then 2 consecutive days every other week during study weeks 6-12, for a total of 18 treatments [see note below] in 12 weeks. For each treatment, they undergo leukapheresis to collect white cells for UVA treatment. Blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are extracted and the rest of the blood is returned through the same needle. A drug called UVADEX is added to the cells to increase their sensitivity to the UVA light treatment, and the treated cells are then reinfused into the patient. On the first day of every 2-day treatment patients are seen in the clinic for blood tests, a check of vital signs, review of possible treatment side effects, and review of disease symptoms. They also fill out questionnaires about how the disease affects their life and activities at weeks 4 and 12, and end of study visit at week 18.

In addition, participants may take part in a substudy designed to better understand how ECP produces its effects. This involves additional patient monitoring with two colonoscopies and two additional blood draws. Colonoscopy uses a lighted tube advanced through the gut to examine the lining of the gut and determine the amount of inflammation. At the time of the procedure, tissue samples (biopsies) are collected for testing. The colonoscopies are done before treatment and at the end of treatment. The extra blood tests are done to look for changes in immune cells and inflammatory chemicals made by the body. They are done before treatment starts, at weeks 6 and 12, and at the end of follow-up.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Pheresis

Lymphocyte

Apoptosis

Cytokine

Colonoscopy

Recruitment Keyword(s):

Crohns Disease

Condition(s):

Crohn Disease

Crohns Disease

Investigational Drug(s):

Uvadex

Investigational Device(s):

None

Interventions:

Drug: Uvadex

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Mary JY, Modigliani R. Development and validation of an endoscopic index of the severity for Crohn's disease: a prospective multicentre study. Groupe d'Etudes Therapeutiques des Affections Inflammatoires du Tube Digestif (GETAID). Gut. 1989 Jul;30(7):983-9.

D'Haens GR, Geboes K, Peeters M, Baert F, Penninckx F, Rutgeerts P. Early lesions of recurrent Crohn's disease caused by infusion of intestinal contents in excluded ileum. Gastroenterology. 1998 Feb;114(2):262-7.

Cappell MS. Gastrointestinal endoscopy in high-risk patients. Dig Dis. 1996 Jul-Aug;14(4):228-44. Review.

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