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

NCT00303381 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2013-08-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Merck Serono International SA

    collaborator INDUSTRY

  • EMD Serono

    lead INDUSTRY

Principal Investigators

  • Claudia Pena Rossi, M.D. · Merck Serono International SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2003-01-31
Completion
2003-01-31

Countries

  • Germany
  • Israel
  • Netherlands
  • Singapore
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
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 NCT00303381 on ClinicalTrials.gov