A Phase 2 Study of Avonex in Ulcerative Colitis - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00616434

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 II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Interferon beta Interferon-beta Interferon beta 1a Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	120
Study Start Date:	March 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Avonex IM injection, self-administered per protocol	Biological: Avonex (interferon beta-1a) Avonex IM injection, self-administered per protocol.
B: Placebo Comparator 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 < 100,000 cells/mL
Lymphocyte count <1000 cells/mL
Platelet count <100,000 cells/mL
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

Contacts

Contact: Biogen Idec, MD

immunologyclinicaltrials@biogenidec.com

Show 37 Study Locations

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Biogen Idec, MD

Biogen Idec

More Information

No publications provided

Responsible Party:	Biogen Idec ( Medical Director )
Study ID Numbers:	108UC201
Study First Received:	February 5, 2008
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00616434 History of Changes
Health Authority:	United States: Food and Drug Administration; Czech Republic: State Institute for Drug Control; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Hungary: National Institute of Pharmacy; Russia: Pharmacological Committee, Ministry of Health; Canada: Health Canada; Slovakia: State Institute for Drug Control

Study placed in the following topic categories:

Immunologic Factors
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Interferons
Adjuvants, Immunologic
Interferon-beta
Inflammatory Bowel Diseases

Colitis, Ulcerative
Intestinal Diseases
Antiviral Agents
Digestive System Diseases
Interferon beta 1a
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Ulcer
Physiological Effects of Drugs
Colonic Diseases
Adjuvants, Immunologic
Interferon-beta
Inflammatory Bowel Diseases

Colitis, Ulcerative
Intestinal Diseases
Antiviral Agents
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Therapeutic Uses
Interferon beta 1a
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on May 07, 2009