Status:
COMPLETED
A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis
Lead Sponsor:
Biogen
Conditions:
Active Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to evaluate the clinical activity of interferon beta-1a in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this study are to...
Eligibility Criteria
Inclusion
- Key
- Established diagnosis of ulcerative colitis (UC) for ≥6 months
- 20 cm active disease at Screening endoscopy
- Must have active UC with a Mayo Score/Disease Activity Index (DAI) of 6 to 13 points and moderate to severe disease on endoscopy (Mayo endoscopic score of at least 2) despite prior or concomitant treatment
- 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.
- Key
Exclusion
- Diagnosis of indeterminate colitis or Crohn's disease
- Need for imminent surgery
- Diagnosis of primary sclerosing cholangitis or toxic megacolon
- Hemoglobin ≤9 g/dL
- White blood cell count \< 3500 cells/mm\^3
- Lymphocyte count \<1000 cells/µL
- Platelet count \<100,000 cells/µL
- 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
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00616434
Start Date
May 1 2008
End Date
March 1 2010
Last Update
August 13 2014
Active Locations (35)
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1
Investigator
Birmingham, Alabama, United States, 35294
2
Investigator
Lakewood, Colorado, United States, 80215
3
Investigator
Bristol, Connecticut, United States, 06010
4
Investigator
Wellesley Hills, Massachusetts, United States, 02481