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

Information source: EMD Serono
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Interferon beta-1a (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Claudia Pena Rossi, M.D., Study Director, Affiliation: EMD Serono

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.

Clinical Details

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

Primary outcome: 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:

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Locations and Contacts

Medical Information Office, Munich, Germany

Medical Information Office, Roma, Italy

Medical Information Office, Solna, Sweden

Medical Information Office, Zug, Switzerland

Medical Information Office, Feltham, United Kingdom

Additional Information

Full FDA approved prescribing information can be found here

Starting date: November 2001
Last updated: August 4, 2013

Page last updated: August 20, 2015

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