Interferon-beta1a (AVONEX) Treatment of Ulcerative Colitis

Completed · Phase 2

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID: NCT00048347
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 18
Starts: 2002-10-01
Expected to finish: 2010-05-01
Last updated by the study team: 2010-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Inability to meet any of the above inclusion criteria.
Use of any of the following medications within the specified time period prior to the first dose of interferon-beta or at any time during the study:
Non-steroidal anti-inflammatory agents (including COX-2 inhibitors), - 1 week
Corticosteroids (greater than 25 mg Prednisone/d or Prednisone equivalent), Methotrexate, Cyclosporin, Tacrolimus, Thalidomide, or Mycophenolate mofetil - 4 weeks
Monoclonal antibodies to TNF alpha or any Other Biologic (cytokine, anti-cytokine, or integrin-based therapy, for instance) - 4 months
Any experimental agent - 1 month
Concomitant use of any of the following drugs: isoniazid, iproniazid, dantrolene, ticrynafen (tienilic acid), ibufenac, bromfenac, benoxaprofen, zileutan, nicotinic acid, trovafloxacin, perhexiline, dilevavol, labetalol, pemoline, felbamate, tolcapone, diclofenac, AIDS drugs (HIV+ subjects are excluded anyway), and troglitozone.
History of colectomy, partial colectomy, current ostomy, or pouchitis.
Presence of significant electrocardiogram abnormalities including QT(c) greater than or equal to 0.48 sec, Mobitz type II second degree or third degree atrioventricular block, left bundle branch block or right bundle branch block accompanied by any fascicular block, changes consistent with acute ischemia or pericarditis.
Presence of a diagnosis of Crohn's disease, indeterminate colitis, microscopic colitis, ischemic colitis, or colitis attributable to infection. This determination may require use of clinical, endoscopic, and histologic data.
Presence of Cushing's syndrome.
Presence of current active bowel obstruction, intestinal perforation, significant GI hemorrhage, known presence of high grade stricture, history of toxic megacolon, history of colonic epithelium high-grade dysplasia or a dysplasia-associated lesion or mass that does not resemble an adenoma (that is a mass lesion, stricture, or broad-based tumor).
Anticipation that surgery may be required to treat the ulcerative colitis within 3 months of study entry.
HIV positivity or signs and symptoms consistent with HIV infection.
Acute systemic or intestinal infection requiring antibiotics.
Active hepatitis B or C.
Decompensated liver disease (Childs-Pugh class B or C).
Hematocrit less than 30 percent
Platelet count 120,000 less than or greater than 850,000
PT INR greater than 1.3 or PTT prolonged by greater than 3 seconds
Serum creatinine or BUN greater than 1.5 times the upper limit of normal (ULN)
ALT (SGPT) or AST (SGOT) greater than 2 times the ULN
Total bilirubin greater than 1.25 times the ULN
Alkaline phosphatase greater than 1.5 times the ULN.
Pregnancy or nursing (for women).

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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