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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00750490 |
This study will evaluate the effectiveness of Avonex (interferon-beta-1a), a drug approved to treat multiple sclerosis, in controlling the symptoms of ulcerative colitis. People with ulcerative colitis have increased levels of an inflammatory chemical made by the body called IL-13. Avonex may inhibit production of IL-13 and interrupt the inflammatory process in the colon.
People between 18 and 65 years of age who have had ulcerative colitis for at least 6 months may be eligible for this study as follows:
Screening Visits
Random assignment to take Avonex or placebo during the study
0-week Visit (3 to 7 days after colonoscopy)
First injection of Avonex or placebo and instruction on how to self-inject the treatment
4-week, 8-week and 12-week Visits
Review of study treatment dosing diary
16-week Visit
Subjects may be asked to participate in a substudy, in which they undergo all the above procedures as well as the following:
Condition | Intervention | Phase |
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Inflammatory Bowel Disease Colitis Digestive Disease Ulcerative Colitis |
Drug: AVONEX |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability, and Efficacy of AVONEX in Subjects With Moderate to Severe Ulcerative Colitis |
Estimated Enrollment: | 20 |
Study Start Date: | September 2008 |
The objective of this National Institutes of Health (NIH) specific substudy is immunological monitoring of cytokine and immune cell responses in subjects undergoing treatment with AVONEX (Interferon-beta 1a) for moderate to severe ulcerative colitis. Recent data suggests that interleukin-14 (IL-13) is an important mediator of inflammation in ulcerative colitis, and type-I interferons such as AVONEX have the potential to block IL-13 signaling. In addition, 4 small clinical studies have showed that type I interferons have therapeutic activity in ulcerative colitis. This study will measure changes in cytokine production, relevant RNA expression, and immune cell populations (in the periphery and lamina propria) for correlation with clinical outcomes in order to understand the mechanisms of therapeutic response.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Any of the following abnormal laboratory results:
Subjects who are positive for HBsAg, HCV, or HIV at Screening
(Medical History)
History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to Screening.
(Treatment History)
Previous treatment with interferon Beta or other interferon products.
(Miscellaneous)
SUB STUDY
INCLUSION CRITERIA
You must be enrolled in the main protocol to participate in the substudy.
EXCLUSION CRITERIA
Platelet count less than 90,000 per milliliter
Prothrombin time International Normalized Ratio greater than 1.3 or partial thromboplastin time greater than 3 seconds control.
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | ( Alisa Dungy ) |
Study ID Numbers: | 080209, 08-I-0209 |
Study First Received: | September 9, 2008 |
Last Updated: | November 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00750490 |
Health Authority: | United States: Federal Government |
Interferon Beta 1-a IM Injection IL-13 Inflammation |
Neopterin Ulcerative Colitis Inflammatory Bowel Disease Colitis |
Gastrointestinal Diseases Ulcer Colonic Diseases Interferons Interferon-beta Inflammatory Bowel Diseases Colitis, Ulcerative |
Intestinal Diseases Inflammation Digestive System Diseases Interferon beta 1a Gastroenteritis Colitis |
Pathologic Processes Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |