Clinical trial NCT00616434: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Active Ulcerative Colitis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With a Clinical Response
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 16 weeks
measure: Percentage of Participants With a Decrease on Simple Clinical Colitis Activity Index (SCCAI) of ≥3 Points at Week 8
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigator
state: Alabama
city: Lakewood
country: United States
facility: Investigator
state: Colorado
city: Bristol
country: United States
facility: Investigator
state: Connecticut
city: Wellesley Hills
country: United States
facility: Investigator
state: Massachusetts
city: Oklahoma City
country: United States
facility: Investigator
state: Oklahoma
city: Calgary
country: Canada
facility: Investigator
state: Alberta
city: Kelowna
country: Canada
facility: Investigator
state: British Columbia
city: Winnipeg
country: Canada
facility: Investigator
state: Manitoba
city: Hradec Kralove
country: Czech Republic
facility: Investigator
city: Ostrava
country: Czech Republic
facility: Investigator
city: Parbudice
country: Czech Republic
facility: Investigator
city: Praha 4
country: Czech Republic
facility: Investigator
city: Praha 7
country: Czech Republic
facility: Investigator
city: Slany
country: Czech Republic
facility: Investigator
city: Teplice
country: Czech Republic
facility: Investigator
city: Budapest
country: Hungary
facility: Investigator
city: Eger
country: Hungary
facility: Investigator
city: Szeged
country: Hungary
facility: Investigator
city: Szekesfehervar
country: Hungary
facility: Investigator
city: Lublin
country: Poland
facility: Investigator
city: Pruszkow
country: Poland
facility: Investigator
city: Sopot
country: Poland
facility: Investigator
city: Torun
country: Poland
facility: Investigator
city: Warszawa
country: Poland
facility: Investigator
city: Wroclaw
country: Poland
facility: Investigator
city: Kazan
country: Russian Federation
facility: Investigator
city: Krasnodar
country: Russian Federation
facility: Investigator
city: Lipetsk
country: Russian Federation
facility: Investigator
city: Moscow
country: Russian Federation
facility: Investigator
city: Nizhniy Novgorod
country: Russian Federation
facility: Investigator
city: Rostov-on-Don
country: Russian Federation
facility: Investigator
city: Saratov
country: Russian Federation
facility: Investigator
city: St. Petersburg
country: Russian Federation
facility: Investigator
city: Yaroslavl
country: Russian Federation
facility: Investiator
city: Nitra
country: Slovakia
facility: Investigator
city: Trencin
country: Slovakia
facility: Investigator
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: