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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00616434
First Posted: February 15, 2008
Last Update Posted: August 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
February 5, 2008
February 15, 2008
July 23, 2014
August 13, 2014
August 13, 2014
May 2008
March 2010   (Final data collection date for primary outcome measure)
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.
Clinical response [ Time Frame: Week 8 ]
Complete list of historical versions of study NCT00616434 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Safety and tolerability of Avonex in subjects with UC [ Time Frame: Week 16 ]
Not Provided
Not Provided
 
A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Active Ulcerative Colitis
  • Drug: BG9418 (Interferon beta-1a)
    Avonex IM injection, self-administered per protocol
    Other Name: Avonex®
  • Drug: Placebo
    Placebo IM injection, self-administered per protocol.
  • Experimental: Interferon beta-1a
    Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
    Intervention: Drug: BG9418 (Interferon beta-1a)
  • Placebo Comparator: Placebo
    Placebo IM injection twice weekly for 12 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
March 2010
March 2010   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Hungary,   Poland,   Russian Federation,   Slovakia,   United States
 
 
NCT00616434
108UC201
2007-004867-22 ( EudraCT Number )
No
Not Provided
Not Provided
Biogen
Biogen
Not Provided
Study Director: Medical Director Biogen
Biogen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP