NCT00303381

Safety and Efficacy of Interferon-Beta-1a (Rebif®) for Treating Subjects With Acute Symptoms of Ulcerative Colitis

A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose-finding Phase II Study of Subcutaneously Administered IFN-beta-1a in the Treatment of Patients With Moderately Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 194 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of interferon-beta-1a in subjects with active ulcerative colitis (UC).

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Interferon-beta-1a, 44 microgram	Interferon-beta-1a will be administered subcutaneously at a dose of 44 mcg, three times a week up to Week 8.
DRUG	Placebo	Matching Placebo will be administered subcutaneously, three times a week up to Week 8.
DRUG	Interferon-beta-1a, 66 microgram	Interferon-beta-1a will be administered subcutaneously at a dose of 66 mcg, three times a week up to Week 8.

Timeline

• Start date: 2001-12-01
• Primary completion: 2003-01-01
• Completion: 2003-01-01
• First posted: 2006-03-16
• Last updated: 2013-08-06

Locations

7 sites across 7 countries: Germany, Israel, Netherlands, Singapore, Sweden, Switzerland, United Kingdom