Interferon-beta1a (AVONEX) Treatment of Ulcerative Colitis
Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effectiveness of the drug interferon-beta1a (AVONEX)
in treating ulcerative colitis and examine the drug's effect on the immune system. People
with ulcerative colitis have increased amounts of inflammatory chemicals (cytokines) made by
immune cells in the lining of the colon. Studies have shown that interferon-beta may block
the activity of these cytokines. Interferon-beta1a (AVONEX) is currently FDA-approved to
treat multiple sclerosis, a disease involving inflammation of the brain and spinal cord.
Patients 18 years of age and older who have had ulcerative colitis for at least 4 months may
be eligible for this study. Candidates will be screened with a review of their medical
records, a medical history and physical examination, electrocardiogram (EKG), blood, urine,
and stool tests, and a pregnancy test for women of childbearing potential. A colonoscopy will
also be done to determine disease activity and extent. This test uses a lighted tube to
examine the amount of inflammation in the colon and take tissue samples (biopsies) for
testing. Before the test, the patient is given a medicine to allay anxiety and the discomfort
of inserting the endoscope into the rectum. This flexible tube allows the doctor to see the
intestinal mucosa and project an image of the inner lining of the intestine onto a TV
monitor. At various places in the intestine, small pieces of tissue are plucked out by a
special device at the tip of the endoscope. The procedure generally lasts 30 minutes to 1
hour.
Participants will come to the NIH Clinical Center once a week for 4 weeks to receive an
injection of interferon-beta, fill out questionnaires, and have a symptoms check, physical
examination, and blood tests. Patients whose colitis has not worsened at the end of the 4
weeks and who have not had significant drug side effects will continue to receive weekly
injections for an additional 8 weeks. Some patients may receive some of the last eight
injections outside of NIH, but all patients will visit the Clinical Center visits every 3 to
4 weeks for a physical exam, symptoms check and blood tests.
After the 12 injections are completed, patients will have another colonoscopy to evaluate the
response to treatment and will return to the Clinical Center every 6 weeks for a total of
four visits, for a physical examination, symptoms check and blood tests.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)