A Phase 2 Study of Avonex in Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00616434
First received: February 5, 2008
Last updated: September 12, 2013
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Active Ulcerative Colitis
Biological: Avonex (interferon beta-1a)
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Clinical response [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of Avonex in subjects with UC [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: March 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Avonex IM injection, self-administered per protocol
Biological: Avonex (interferon beta-1a)
Avonex IM injection, self-administered per protocol.
Placebo Comparator: B
Placebo IM injection, self-administered per protocol.
Biological: Placebo

Placebo IM injection, self-administered per protocol.

Placebo looks like Avonex and contains the same liquid as Avonex, but does not contain Avonex itself.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </= 9 g/dL
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616434

  Show 37 Study Locations
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Medical Director, Biogen Idec
ClinicalTrials.gov Identifier: NCT00616434     History of Changes
Obsolete Identifiers: NCT00750490
Other Study ID Numbers: 108UC201
Study First Received: February 5, 2008
Last Updated: September 12, 2013
Health Authority: Russia: Pharmacological Committee, Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 17, 2014