A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis

NCT ID: NCT00616434

Last Updated: 2014-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2010-03-31

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 determine (i) the safety and tolerability of interferon beta-1a in participants with moderate to severe UC, and (ii) the percentage of participants, with a decrease in the Simple Clinical Colitis Activity Index (SCCAI) score of ≥3 points at Week 8.

Conditions

Active Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Interferon beta-1a

Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks

Group Type: EXPERIMENTAL

BG9418 (Interferon beta-1a)

Intervention Type: DRUG

Avonex IM injection, self-administered per protocol

Placebo

Placebo IM injection twice weekly for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo IM injection, self-administered per protocol.

Interventions

BG9418 (Interferon beta-1a)

Avonex IM injection, self-administered per protocol

Intervention Type: DRUG

Placebo

Placebo IM injection, self-administered per protocol.

Intervention Type: DRUG

Other Intervention Names

Avonex®

Eligibility Criteria

Inclusion Criteria

• 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.

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

Investigator

Birmingham, Alabama, United States

Investigator

Lakewood, Colorado, United States

Investigator

Bristol, Connecticut, United States

Investigator

Wellesley Hills, Massachusetts, United States

Investigator

Oklahoma City, Oklahoma, United States

Investigator

Calgary, Alberta, Canada

Investigator

Kelowna, British Columbia, Canada

Investigator

Winnipeg, Manitoba, Canada

Investigator

Hradec Králové, , Czechia

Investigator

Ostrava, , Czechia

Investigator

Parbudice, , Czechia

Investigator

Prague, , Czechia

Investigator

Slaný, , Czechia

Investigator

Teplice, , Czechia

Investigator

Budapest, , Hungary

Investigator

Eger, , Hungary

Investigator

Szeged, , Hungary

Investigator

Székesfehérvár, , Hungary

Investigator

Lublin, , Poland

Investigator

Pruszków, , Poland

Investigator

Sopot, , Poland

Investigator

Torun, , Poland

Investigator

Warsaw, , Poland

Investigator

Wroclaw, , Poland

Investigator

Kazan', , Russia

Investigator

Krasnodar, , Russia

Investigator

Lipetsk, , Russia

Investigator

Moscow, , Russia

Investigator

Nizhny Novgorod, , Russia

Investigator

Rostov-on-Don, , Russia

Investigator

Saint Petersburg, , Russia

Investigator

Saratov, , Russia

Investiator

Yaroslavl, , Russia

Investigator

Nitra, , Slovakia

Investigator

Trenčín, , Slovakia

Countries

United States; Canada; Czechia; Hungary; Poland; Russia; Slovakia

Other Identifiers

2007-004867-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

108UC201

Identifier Type: -

Identifier Source: org_study_id

NCT00750490

Identifier Type: -

Identifier Source: nct_alias