At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Confirmed diagnosis of ulcerative colitis for at least 4 months based on endoscopic, radiographic, and histopathologic findings
- ✓Active disease with Simple Clinical Colitis Activity Index ≥5, with reproducible measurements within 50% of each other
- ✓Current corticosteroid-dependence, disease refractory to corticosteroids, or history of steroid intolerance
- ✕Diagnosis of Crohn's disease, indeterminate colitis, microscopic colitis, ischemic colitis, or infectious colitis
- ✕History of colectomy, partial colectomy, current ostomy, or pouchitis
- ✕Severe gastrointestinal complications including perforation, high-grade stricture, toxic megacolon, high-grade dysplasia, or dysplasia-associated lesion/mass
- ✕Significant EKG abnormalities including QTc ≥0.48 sec, Mobitz II block, third-degree AV block, or bundle branch blocks with fascicular block
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Pilot Study of Type I Interferon (AVONEX) Treatment of Ulcerative Colitis
In Brief
A Phase 2 clinical trial evaluating AVONEX for Ulcerative Colitis. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
30µg IM every week for 12 weeks