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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)
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00304252
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 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
Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

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
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304252

Locations
Germany
Medical Information Office
Munich, Germany
Italy
Medical Information Office
Roma, Italy
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 by EMD Serono

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00304252     History of Changes
Other Study ID Numbers: 22916, 9903
Study First Received: March 14, 2006
Last Updated: March 21, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
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