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

NCT00616434 | Completed Phase 2 Results

• 2 other identifiers: 108UC2012007-004867-22
• Study Type: interventional
• Target: 123
• Locations: 7 countries
• Sites: 35

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Clinical Response

  Clinical response is defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30%, accompanied by a decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of 1 or less. Baseline was defined as the score collected during the screening period. The Mayo Score/Disease Activity Index (DAI) measures disease activity through assessment of 4 items: stool frequency, rectal bleeding, endoscopy findings, and Physician Global Assessment (PGA). Each item of the score is assessed on a 4-point scale, 0, 1, 2, or 3, with a higher score representing greater severity. In this study, the endoscopy subscore was expanded to a 5-point scale to increase sensitivity in this important dimension of the disease (0=normal/inactive disease, 4=deep ulceration). The Total Mayo Score can therefore range from 0 to13 points.

  Baseline and Week 8

Secondary Outcomes (2)

• Number of Participants With Adverse Events (AEs)

  Up to 16 weeks

• Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8

  Baseline and Week 8

Study Arms (2)

Interferon beta-1a

EXPERIMENTAL

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

Drug: BG9418 (Interferon beta-1a)

Placebo

PLACEBO COMPARATOR

Placebo IM injection twice weekly for 12 weeks

Drug: Placebo

Interventions

BG9418 (Interferon beta-1a) DRUG

Avonex IM injection, self-administered per protocol

Also known as: Avonex®

Interferon beta-1a

Placebo DRUG

Placebo IM injection, self-administered per protocol.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Established diagnosis of ulcerative colitis (UC) for ≥6 months
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (35)

Investigator

Birmingham, Alabama, 35294, United States

Location

Investigator

Lakewood, Colorado, 80215, United States

Location

Investigator

Bristol, Connecticut, 06010, United States

Location

Investigator

Wellesley Hills, Massachusetts, 02481, United States

Location

Investigator

Oklahoma City, Oklahoma, 73104, United States

Location

Investigator

Calgary, Alberta, T2N4N1, Canada

Location

Investigator

Kelowna, British Columbia, V1Y 2H4, Canada

Location

Investigator

Winnipeg, Manitoba, R3A1R9, Canada

Location

Investigator

Hradec Králové, Czechia

Location

Investigator

Ostrava, Czechia

Location

Investigator

Parbudice, Czechia

Location

Investigator

Prague, Czechia

Location

Investigator

Slaný, Czechia

Location

Investigator

Teplice, Czechia

Location

Investigator

Budapest, Hungary

Location

Investigator

Eger, Hungary

Location

Investigator

Szeged, Hungary

Location

Investigator

Székesfehérvár, Hungary

Location

Investigator

Lublin, Poland

Location

Investigator

Pruszków, Poland

Location

Investigator

Sopot, Poland

Location

Investigator

Torun, Poland

Location

Investigator

Warsaw, Poland

Location

Investigator

Wroclaw, Poland

Location

Investigator

Kazan', Russia

Location

Investigator

Krasnodar, Russia

Location

Investigator

Lipetsk, Russia

Location

Investigator

Moscow, Russia

Location

Investigator

Nizhny Novgorod, Russia

Location

Investigator

Rostov-on-Don, Russia

Location

Investigator

Saint Petersburg, Russia

Location

Investigator

Saratov, Russia

Location

Investiator

Yaroslavl, Russia

Location

Investigator

Nitra, Slovakia

Location

Investigator

Trenčín, Slovakia

Location

MeSH Terms

Interventions

Interferon beta-1a

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Biogen Idec Study Medical Director
• Organization: Biogen Idec

clinicaltrials@biogenidec.com

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 15, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 13, 2014
• Results First Posted: August 13, 2014

Record last verified: 2014-07

Locations

CZ (6); HU (4); SL (2); US (5); CA (3); PL (6); RU (9)