Back to resultsSafety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Interferon beta-1a
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility 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
Sites / Locations
- Medical Information Office
- Medical Information Office
- Medical Information Office
- Medical Information Office
- Medical Information Office
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00304252
Brief Title
Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of Efficacy
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
EMD Serono
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
192 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The secondary efficacy endpoints assessed the effect of treatment with IFN beta 1a on the following measures:
Title
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
Title
Time to relapse
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Pena Rossi, M.D.
Organizational Affiliation
EMD Serono
Official's Role
Study Director
Facility Information:
Facility Name
Medical Information Office
City
Munich
Country
Germany
Facility Name
Medical Information Office
City
Roma
Country
Italy
Facility Name
Medical Information Office
City
Solna
Country
Sweden
Facility Name
Medical Information Office
City
Zug
Country
Switzerland
Facility Name
Medical Information Office
City
Feltham
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19302707
Citation
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. doi: 10.1186/1471-230X-9-22.
Results Reference
derived
Links:
URL
http://www.mslifelines.com
Description
Full FDA approved prescribing information can be found here
Learn more about this trial
Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease
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