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

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00303381
First received: March 14, 2006
Last updated: March 21, 2009
Last verified: March 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:

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

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

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on June 18, 2013