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Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease

This study has been terminated.
(Lack of Efficacy)
Information provided by:
EMD Serono Identifier:
First received: March 14, 2006
Last updated: August 4, 2013
Last verified: August 2013
The purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with Crohn's disease.

Condition Intervention Phase
Crohn's Disease
Drug: Interferon beta-1a
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease

Resource links provided by NLM:

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • The primary efficacy endpoint was the proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 26.

Secondary Outcome Measures:
  • The secondary efficacy endpoints assessed the effect of treatment with IFN beta 1a on the following measures:
  • The proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 52
  • Time to relapse
  • Change from baseline to end of treatment in Quality of Life (IBDQ) score, CDAI score, biological markers of inflammation (CRP and ESR), number of fistulas (including new fistulas and closure of existing ones), and antibodies to interferon beta-1a.

Estimated Enrollment: 192
Study Start Date: November 2001
Study Completion Date: September 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Patients with an established diagnosis of Crohn's disease who went into remission using corticosteroids within 4 weeks before the study

Exclusion Criteria:

  • Any other treatment for the maintenance of remission of Crohn's disease
  Contacts and Locations
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Please refer to this study by its identifier: NCT00304252

Medical Information Office
Munich, Germany
Medical Information Office
Roma, Italy
Medical Information Office
Solna, Sweden
Medical Information Office
Zug, Switzerland
United Kingdom
Medical Information Office
Feltham, United Kingdom
Sponsors and Collaborators
EMD Serono
Study Director: Claudia Pena Rossi, M.D. EMD Serono
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00304252     History of Changes
Other Study ID Numbers: 22916
Study First Received: March 14, 2006
Last Updated: August 4, 2013

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic processed this record on May 25, 2017