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

Primary Purpose

Active Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BG9418 (Interferon beta-1a)
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Ulcerative Colitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Interferon beta-1a

Placebo

Arm Description

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

Placebo IM injection twice weekly for 12 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE, can therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AE's were analyzed based on the principle of treatment emergence. An AE was regarded as treatment-emergent if it was not present prior to receiving the first injection but subsequently appeared, or if it was present prior to receiving the first injection and subsequently worsened in severity.
Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8
The SCCAI measures disease activity as defined by both participants and examiners and includes the following 13 items: general well-being, abdominal pain, bowel frequency, stool consistency, bleeding, anorexia, nausea or vomiting, abdominal tenderness, extra-intestinal complications (eye, mouth, joint, skin), temperature, sigmoidoscopic assessment, nocturnal bowel movements, and urgency of defecation. Scores range from 0 to 19 points, and scores <2.5 have been shown to correlate with Patient-Defined Remission, and a decrease of >1.5 points from Baseline correlates with Patient-Defined Significant Improvement. Baseline is defined as the mean of the screening and visit 1 scores.

Full Information

First Posted
February 5, 2008
Last Updated
July 23, 2014
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00616434
Brief Title
A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interferon beta-1a
Arm Type
Experimental
Arm Description
Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo IM injection twice weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
BG9418 (Interferon beta-1a)
Other Intervention Name(s)
Avonex®
Intervention Description
Avonex IM injection, self-administered per protocol
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo IM injection, self-administered per protocol.
Primary Outcome Measure Information:
Title
Percentage of Participants With a Clinical Response
Description
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.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE, can therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. All AE's were analyzed based on the principle of treatment emergence. An AE was regarded as treatment-emergent if it was not present prior to receiving the first injection but subsequently appeared, or if it was present prior to receiving the first injection and subsequently worsened in severity.
Time Frame
Up to 16 weeks
Title
Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8
Description
The SCCAI measures disease activity as defined by both participants and examiners and includes the following 13 items: general well-being, abdominal pain, bowel frequency, stool consistency, bleeding, anorexia, nausea or vomiting, abdominal tenderness, extra-intestinal complications (eye, mouth, joint, skin), temperature, sigmoidoscopic assessment, nocturnal bowel movements, and urgency of defecation. Scores range from 0 to 19 points, and scores <2.5 have been shown to correlate with Patient-Defined Remission, and a decrease of >1.5 points from Baseline correlates with Patient-Defined Significant Improvement. Baseline is defined as the mean of the screening and visit 1 scores.
Time Frame
Baseline and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Investigator
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Investigator
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Investigator
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Investigator
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Investigator
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Investigator
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Facility Name
Investigator
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 2H4
Country
Canada
Facility Name
Investigator
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A1R9
Country
Canada
Facility Name
Investigator
City
Hradec Kralove
Country
Czech Republic
Facility Name
Investigator
City
Ostrava
Country
Czech Republic
Facility Name
Investigator
City
Parbudice
Country
Czech Republic
Facility Name
Investigator
City
Praha 4
Country
Czech Republic
Facility Name
Investigator
City
Praha 7
Country
Czech Republic
Facility Name
Investigator
City
Slany
Country
Czech Republic
Facility Name
Investigator
City
Teplice
Country
Czech Republic
Facility Name
Investigator
City
Budapest
Country
Hungary
Facility Name
Investigator
City
Eger
Country
Hungary
Facility Name
Investigator
City
Szeged
Country
Hungary
Facility Name
Investigator
City
Szekesfehervar
Country
Hungary
Facility Name
Investigator
City
Lublin
Country
Poland
Facility Name
Investigator
City
Pruszkow
Country
Poland
Facility Name
Investigator
City
Sopot
Country
Poland
Facility Name
Investigator
City
Torun
Country
Poland
Facility Name
Investigator
City
Warszawa
Country
Poland
Facility Name
Investigator
City
Wroclaw
Country
Poland
Facility Name
Investigator
City
Kazan
Country
Russian Federation
Facility Name
Investigator
City
Krasnodar
Country
Russian Federation
Facility Name
Investigator
City
Lipetsk
Country
Russian Federation
Facility Name
Investigator
City
Moscow
Country
Russian Federation
Facility Name
Investigator
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Investigator
City
Rostov-on-Don
Country
Russian Federation
Facility Name
Investigator
City
Saratov
Country
Russian Federation
Facility Name
Investigator
City
St. Petersburg
Country
Russian Federation
Facility Name
Investiator
City
Yaroslavl
Country
Russian Federation
Facility Name
Investigator
City
Nitra
Country
Slovakia
Facility Name
Investigator
City
Trencin
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

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

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