CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
BG9418 (Interferon beta-1a) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00616434
NCT00616434Phase 2Completed
CompareCT.gov

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

Biogen·interventional·Posted Feb 15, 2008·Updated Aug 13, 2014

In Brief

A Phase 2 clinical trial evaluating BG9418 (Interferon beta-1a) and Placebo for Active Ulcerative Colitis. Completed, enrolled 123 participants across 35 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActive Ulcerative Colitis
CountriesCanada, Czechia, Hungary, Poland, Russia, Slovakia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 15, 2008
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.4 years ago

Interventions

BG9418 (Interferon beta-1a)drug

Avonex IM injection, self-administered per protocol

Placebodrug

Placebo IM injection, self-administered per protocol.