NCT00616434

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Active Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	BG9418 (Interferon beta-1a)	Avonex IM injection, self-administered per protocol
DRUG	Placebo	Placebo IM injection, self-administered per protocol.

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-02-15
• Last updated: 2014-08-13
• Results posted: 2014-08-13

Locations

35 sites across 7 countries: United States, Canada, Czechia, Hungary, Poland, Russia, Slovakia