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

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ClinicalTrials.gov Identifier: NCT00616434
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Active Ulcerative Colitis Drug: BG9418 (Interferon beta-1a) Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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 Start Date : May 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Interferon beta-1a
Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
 Drug: BG9418 (Interferon beta-1a)
Avonex IM injection, self-administered per protocol
Other Name: Avonex®
Placebo Comparator: Placebo
Placebo IM injection twice weekly for 12 weeks
 Drug: Placebo
Placebo IM injection, self-administered per protocol.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With a Clinical Response [ Time Frame: Baseline and Week 8 ]
    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 :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 16 weeks ]
    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.

  2. Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8 [ Time Frame: Baseline and 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616434


  Show 36 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00616434     History of Changes
Obsolete Identifiers: NCT00750490
Other Study ID Numbers: 108UC201
2007-004867-22 ( EudraCT Number )
First Posted: February 15, 2008    Key Record Dates
Results First Posted: August 13, 2014
Last Update Posted: August 13, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
 Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic