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NCT00304252 Clinical Trial

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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00304252
Other study ID # 22916
Secondary ID 9903
Status Terminated
Phase Phase 2
First received March 14, 2006
Last updated August 4, 2013
Start date November 2001
Est. completion date September 2003

Study information
Verified date August 2013
Source EMD Serono
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 192
Est. completion date September 2003
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Interferon beta-1a

Locations
Country Name City State
Germany Medical Information Office Munich
Italy Medical Information Office Roma
Sweden Medical Information Office Solna
Switzerland Medical Information Office Zug
United Kingdom Medical Information Office Feltham

Sponsors (1)
Lead Sponsor Collaborator
EMD Serono

Countries where clinical trial is conducted

Germany,  Italy,  Sweden,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 The secondary efficacy endpoints assessed the effect of treatment with IFN beta 1a on the following measures:
Secondary 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
Secondary Time to relapse
Secondary 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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