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

NCT00616434 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2014-08-13

Study results available
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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

DRUG

BG9418 (Interferon beta-1a)

Avonex IM injection, self-administered per protocol

DRUG

Placebo

Placebo IM injection, self-administered per protocol.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States
  • Canada
  • Czechia
  • Hungary
  • Poland
  • Russia
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00616434 on ClinicalTrials.gov