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

Tracking Information

First Received Date ^ICMJE

March 14, 2006

Last Updated Date

March 21, 2009

Start Date ^ICMJE

November 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00304252 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Crohn's Disease

Intervention ^ICMJE

Drug: Interferon beta-1a

Study Arm (s)

Not Provided

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

192

Completion Date

September 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Italy, Sweden, Switzerland, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00304252

Other Study ID Numbers ^ICMJE

22916, 9903

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

EMD Serono

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Claudia Pena Rossi, M.D.

EMD Serono

Information Provided By

EMD Serono

Verification Date

March 2009

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

To Top