BENEFIT Extension Study

NCT ID: NCT00544037

Last Updated: 2012-03-05

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

COMPLETED

Total Enrollment

283 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-01-31

Brief Summary

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To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Interferon beta-1b (Betaseron, BAY86-5046)

Intervention Type DRUG

Standard Therapy for Multiple Sclerosis

Interventions

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Interferon beta-1b (Betaseron, BAY86-5046)

Standard Therapy for Multiple Sclerosis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients randomized and treated at least once in study 304747

Exclusion Criteria

* Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study
Minimum Eligible Age

23 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Byer Healthcare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Austria

Site Status

Many Locations, , Belgium

Site Status

Many Locations, , Canada

Site Status

Many Locations, , Czechia

Site Status

Many Locations, , Denmark

Site Status

Many Locations, , Finland

Site Status

Many Locations, , France

Site Status

Many Locations, , Germany

Site Status

Many Locations, , Hungary

Site Status

Many Locations, , Israel

Site Status

Many Locations, , Italy

Site Status

Many Locations, , Netherlands

Site Status

Many Locations, , Norway

Site Status

Many Locations, , Poland

Site Status

Many Locations, , Slovenia

Site Status

Many Locations, , Spain

Site Status

Many Locations, , Sweden

Site Status

Many Locations, , Switzerland

Site Status

Countries

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Austria Belgium Canada Czechia Denmark Finland France Germany Hungary Israel Italy Netherlands Norway Poland Slovenia Spain Sweden Switzerland

References

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Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.

Reference Type DERIVED
PMID: 23842212 (View on PubMed)

Other Identifiers

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311129

Identifier Type: OTHER

Identifier Source: secondary_id

91713

Identifier Type: -

Identifier Source: org_study_id

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