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: August 4, 2013
Last verified: August 2013

March 14, 2006
August 4, 2013
November 2001
Not Provided
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.
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Complete list of historical versions of study NCT00304252 on ClinicalTrials.gov Archive Site
  • 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.
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Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Crohn's Disease
Drug: Interferon beta-1a
Not Provided
Pena Rossi C, Hanauer SB, Tomasevic R, Hunter JO, Shafran I, Graffner H. Interferon beta-1a for the maintenance of remission in patients with Crohn's disease: results of a phase II dose-finding study. BMC Gastroenterol. 2009 Mar 20;9:22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
192
September 2003
Not Provided

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Sweden,   Switzerland,   United Kingdom
 
NCT00304252
22916, 9903
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EMD Serono
Not Provided
Study Director: Claudia Pena Rossi, M.D. EMD Serono
EMD Serono
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP