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

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Active Ulcerative Colitis

Intervention: BG9418 (Interferon beta-1a) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

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.

Clinical Details

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

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

Primary outcome: Percentage of Participants With a Clinical Response

Secondary outcome:

Number of Participants With Adverse Events (AEs)

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Key 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. Key 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations and Contacts

Investigator, Hradec Kralove, Czech Republic

Investigator, Ostrava, Czech Republic

Investigator, Parbudice, Czech Republic

Investigator, Praha 4, Czech Republic

Investigator, Praha 7, Czech Republic

Investigator, Slany, Czech Republic

Investigator, Teplice, Czech Republic

Investigator, Budapest, Hungary

Investigator, Eger, Hungary

Investigator, Szeged, Hungary

Investigator, Szekesfehervar, Hungary

Investigator, Lublin, Poland

Investigator, Pruszkow, Poland

Investigator, Sopot, Poland

Investigator, Torun, Poland

Investigator, Warszawa, Poland

Investigator, Wroclaw, Poland

Investigator, Kazan, Russian Federation

Investigator, Krasnodar, Russian Federation

Investigator, Lipetsk, Russian Federation

Investigator, Moscow, Russian Federation

Investigator, Nizhniy Novgorod, Russian Federation

Investigator, Rostov-on-Don, Russian Federation

Investigator, Saratov, Russian Federation

Investigator, St. Petersburg, Russian Federation

Investiator, Yaroslavl, Russian Federation

Investigator, Nitra, Slovakia

Investigator, Trencin, Slovakia

Investigator, Birmingham, Alabama 35294, United States

Investigator, Calgary, Alberta T2N4N1, Canada

Investigator, Kelowna, British Columbia V1Y 2H4, Canada

Investigator, Lakewood, Colorado 80215, United States

Investigator, Bristol, Connecticut 06010, United States

Investigator, Winnipeg, Manitoba R3A1R9, Canada

Investigator, Wellesley Hills, Massachusetts 02481, United States

Investigator, Oklahoma City, Oklahoma 73104, United States

Additional Information

Starting date: May 2008
Last updated: July 23, 2014

Page last updated: August 20, 2015

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