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

Active Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616434
• Other study ID #: 108UC201
• Secondary ID: 2007-004867-22
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2008
• Last updated: July 23, 2014
• Start date: May 2008
• Est. completion date: March 2010

Study information

• Verified date: July 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian FederationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsCzech Republic: State Institute for Drug ControlSlovakia: State Institute for Drug ControlHungary: National Institute of PharmacyCanada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00750490

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Active Ulcerative Colitis
• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• BG9418 (Interferon beta-1a)
Avonex IM injection, self-administered per protocol
• Placebo
Placebo IM injection, self-administered per protocol.

Locations

Country	Name	City	State
Canada	Investigator	Calgary	Alberta
Canada	Investigator	Kelowna	British Columbia
Canada	Investigator	Winnipeg	Manitoba
Czech Republic	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
Hungary	Investigator	Budapest
Hungary	Investigator	Eger
Hungary	Investigator	Szeged
Hungary	Investigator	Szekesfehervar
Poland	Investigator	Lublin
Poland	Investigator	Pruszkow
Poland	Investigator	Sopot
Poland	Investigator	Torun
Poland	Investigator	Warszawa
Poland	Investigator	Wroclaw
Russian Federation	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
Slovakia	Investigator	Nitra
Slovakia	Investigator	Trencin
United States	Investigator	Birmingham	Alabama
United States	Investigator	Bristol	Connecticut
United States	Investigator	Lakewood	Colorado
United States	Investigator	Oklahoma City	Oklahoma
United States	Investigator	Wellesley Hills	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  Hungary,  Poland,  Russian Federation,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Week 8	No
Secondary	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.	Up to 16 weeks	Yes
Secondary	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.	Baseline and Week 8	No