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

This study has been completed.

First Received: March 14, 2006 Last Updated: March 21, 2009 History of Changes

Sponsored by:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00303381

Purpose

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

Condition	Intervention	Phase
Ulcerative Colitis	Drug: Interferon beta-1a	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Interferon beta Interferon-beta Interferon beta 1a Interferons

U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Endoscopically confirmed remission at any time during treatment

Secondary Outcome Measures:

Patients were evaluated for a variety of other endpoints every 2 weeks for 8 weeks

Estimated Enrollment:	168
Study Start Date:	December 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patients with moderately active ulcerative colitis

Exclusion Criteria:

Main exclusion criterion is systemic treatment with immunosuppressants.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303381

Locations

Germany
Medical Information Office
Munich, Germany
Israel
Medical Information Office
Ness Ziona, Israel
Netherlands
Medical Information Office
Den Haag, Netherlands
Singapore
Medical Information Office
Singapore, Singapore
Spain
Medical Information Office
Madrid, Spain
Sweden
Medical Information Office
Solna, Sweden
Switzerland
Medical Information Office
Zug, Switzerland
United Kingdom
Medical Information Office
Feltham, United Kingdom

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Claudia Pena Rossi, M.D.

EMD Serono

More Information

Additional Information:

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	22648
Study First Received:	March 14, 2006
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00303381 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Infective Agents
Immunologic Factors
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Interferons
Adjuvants, Immunologic
Interferon-beta
Inflammatory Bowel Diseases

Colitis, Ulcerative
Intestinal Diseases
Antiviral Agents
Signs and Symptoms
Digestive System Diseases
Interferon beta 1a
Gastroenteritis
Colitis

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Ulcer
Physiological Effects of Drugs
Colonic Diseases
Interferons
Adjuvants, Immunologic
Interferon-beta
Inflammatory Bowel Diseases

Colitis, Ulcerative
Intestinal Diseases
Antiviral Agents
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Therapeutic Uses
Interferon beta 1a
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on September 02, 2009