A Phase 2 Study of Avonex in Ulcerative Colitis
Information source: Biogen Idec
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Active Ulcerative Colitis
Intervention: Avonex (interferon beta-1a) (Biological); Placebo (Biological)
Phase: Phase 2
Status: Recruiting
Sponsored by: Biogen Idec Official(s) and/or principal investigator(s):
Biogen Idec, MD, Study Director, Affiliation: Biogen Idec
Overall contact:
Biogen Idec, MD, Email: immunologyclinicaltrials@biogenidec.com
Summary
Avonex is an interferon, a type of protein produced by the body to help protect you against
infections. Avonex is similar to the interferons produced by your body. Avonex has been
authorized by the US Food and Drug Administration, Health Canada, and by 69 other countries
for the treatment of multiple sclerosis (MS), a disease of the immune system that damages
the brain and spinal cord. Avonex may be useful in the treatment of ulcerative colitis (UC),
because UC is also a disease of the immune system.
The purpose of this study is to determine if Avonex, a drug currently used to treat MS, can
reduce or eliminate the symptoms of your type of UC (bleeding, abdominal pain, diarrhea,
constipation, irregular bowel movements, and other symptoms) and reduce the inflammation or
heal the inside of the colon that is affected by UC. This study will also determine the
side effects of Avonex treatment and how well Avonex treatment is tolerated by patients
with UC.
Clinical Details
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX in Subjects With Moderate to Severe Ulcerative Colitis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Clinical response
Secondary outcome: Safety and tolerability of Avonex in subjects with UC
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Established diagnosis of UC
- At least 20 cm active disease at Screening endoscopy
- Colonoscopy within past 5 years for extent of disease and to exclude polyps
- For subjects with UC for more than 10 years, colonoscopy with appropriate biopsies
within 1 year prior to Screening to exclude dysplasia and neoplasia.
- Must be willing and able to practice effective birth control during the study and for
1 month after the last dose of study treatment.
Exclusion Criteria:
- Diagnosis of indeterminate colitis or Crohn's disease
- Need for imminent surgery
- Diagnosis of primary sclerosing cholangitis or toxic megacolon
- Hemoglobin
- WBC < 3500 cells/mm^3
- Lymphocyte count <1000 cells/ul
- Platelet count <100,000 cells/ul
- Female subjects who are pregnant or who wish to become pregnant during the study, or
who are lactating
- Known symptomatic colonic stricture
- Stool cultures positive for enteric infection
- History of malignant disease
- History of major abdominal surgery (e. g. gastrectomy) within past 5 years
- History of small bowel or colonic obstruction or resection
- History of drug or alcohol abuse (as defined by the Investigator) within 2 years
prior to Screening
- Use of anti-diarrheal agents during the screening period
- Previous participation in this study
- Previous treatment with interferon beta or other interferon products
Locations and Contacts
Biogen Idec, MD, Email: immunologyclinicaltrials@biogenidec.com
Investigator, Ostrava, Czech Republic; Recruiting
Investigator, Praha 7, Czech Republic; Recruiting
Investigator, Hradec Kralove, Czech Republic; Recruiting
Investigator, Teplice, Czech Republic; Recruiting
Investigator, Praha 4, Czech Republic; Recruiting
Investigator, Slany, Czech Republic; Recruiting
Investigator, Parbudice, Czech Republic; Recruiting
Investigator, Budapest, Hungary; Recruiting
Investigator, Eger, Hungary; Recruiting
Investigator, Szeged, Hungary; Recruiting
Investigator, Szekesfehervar, Hungary; Recruiting
Investigator, Lublin, Poland; Recruiting
Investigator, Sopot, Poland; Recruiting
Investigator, Warszawa, Poland; Recruiting
Investigator, Wroclaw, Poland; Recruiting
Investigator, Pruszkow, Poland; Recruiting
Investigator, Torun, Poland; Recruiting
Investiator, Yaroslavl, Russian Federation; Recruiting
Investigator, Moscow, Russian Federation; Recruiting
Investigator, Saratov, Russian Federation; Recruiting
Investigator, Kazan, Russian Federation; Recruiting
Investigator, St. Petersburg, Russian Federation; Recruiting
Investigator, Lipetsk, Russian Federation; Recruiting
Investigator, Rostov-on-Don, Russian Federation; Recruiting
Investigator, Nizhniy Novgorod, Russian Federation; Recruiting
Investigator, Krasnodar, Russian Federation; Recruiting
Investigator, Nitra, Slovakia; Recruiting
Investigator, Trencin, Slovakia; Recruiting
Investigator, Bratislava, Slovakia; Recruiting
Investigator, Birmingham, Alabama 35294, United States; Recruiting
Investigator, Calgary, Alberta T2N4N1, Canada; Recruiting
Investigator, Lakewood, Colorado 80215, United States; Recruiting
Investigator, Bristol, Connecticut 06010, United States; Recruiting
Investigator, Louisville, Kentucky, United States; Recruiting
Investigator, Winnipeg, Manitoba R3A 1R9, Canada; Recruiting
Investigator, Oklahoma City, Oklahoma 73104, United States; Recruiting
Investigator, Tulsa, Oklahoma 74104, United States; Recruiting
Additional Information
Starting date: March 2008
Ending date: February 2010
Last updated: July 9, 2009
|
