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

NCT ID: NCT00304252

Last Updated: 2013-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2003-09-30

Brief Summary

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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

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Interferon beta-1a

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMD Serono

INDUSTRY

Sponsor Role lead

Principal Investigators

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Claudia Pena Rossi, M.D.

Role: STUDY_DIRECTOR

EMD Serono

Locations

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Medical Information Office

Munich, , Germany

Site Status

Medical Information Office

Roma, , Italy

Site Status

Medical Information Office

Solna, , Sweden

Site Status

Medical Information Office

Zug, , Switzerland

Site Status

Medical Information Office

Feltham, , United Kingdom

Site Status

Countries

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Germany Italy Sweden Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 19302707 (View on PubMed)

Related Links

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http://www.mslifelines.com

Full FDA approved prescribing information can be found here

Other Identifiers

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9903

Identifier Type: -

Identifier Source: secondary_id

22916

Identifier Type: -

Identifier Source: org_study_id