Follow-up Study After 11 Years of Patients Who Were Included in the BENEFIT Trial (304747) With a First Demyelinating Event Suggestive of Multiple Sclerosis

NCT ID: NCT01795872

Last Updated: 2015-07-27

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

Clinical Phase

PHASE4

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-06-30

Brief Summary

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This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.

Detailed Description

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As optic coherence tomography (OCT) and magnetic resonance imaging (MRI) studies are essential to standardize the procedures and assessments for all OCT and MRI test centers that may take part in this study, 122 additional volunteers will be enrolled to test the dummy scans of OCT and MRI, only.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Several diagnostic procedures

Group Type OTHER

Several diagnostic procedures

Intervention Type PROCEDURE

No drug will be assigned, diagnostic assessment within the study.

Interventions

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Several diagnostic procedures

No drug will be assigned, diagnostic assessment within the study.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male and female patients with clinical-isolated syndrome or multiple sclerosis who have been treated at least once in BENEFIT Study 304747

Exclusion Criteria

* Patients who, according to the investigator's judgment, have medical, psychiatric, or other conditions that compromise the patient's ability to understand the purpose of the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Graz, Styria, Austria

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Innsbruck, , Austria

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Bruxelles - Brussel, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Calgary, Alberta, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Montreal, Quebec, Canada

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Brno, , Czechia

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Hradec Králové, , Czechia

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Ostrava-Poruba, , Czechia

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Prague, , Czechia

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Glostrup Municipality, , Denmark

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Oulu, , Finland

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Seinäjoki, , Finland

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Tampere, , Finland

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Turku, , Finland

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Bordeaux, , France

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Clermont-Ferrand, , France

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Dijon, , France

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Lille, , France

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Nice, , France

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Rennes, , France

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Toulouse, , France

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Ulm, Baden-Wurttemberg, Germany

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München, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Hennigsdorf, Brandenburg, Germany

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Giessen, Hesse, Germany

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Marburg, Hesse, Germany

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Offenbach, Hesse, Germany

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Göttingen, Lower Saxony, Germany

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Greifswald, Mecklenburg-Vorpommern, Germany

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Cologne, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Halle, Saxony-Anhalt, Germany

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Erfurt, Thuringia, Germany

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Münster, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Szeged, , Hungary

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Tel Litwinsky, Israel, Israel

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Jerusalem, , Israel

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Orbassano, Torino, Italy

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Gallarate, , Italy

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Milan, , Italy

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Padua, , Italy

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Pavia, , Italy

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Torino, , Italy

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Sittard, , Netherlands

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Bergen, , Norway

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Bydgoszcz, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Wroclaw, , Poland

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Coimbra, Coimbra District, Portugal

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Ljubljana, , Slovenia

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Seville, Andalusia, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Madrid, Madrid, Spain

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Málaga, Málaga, Spain

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Valencia, Valencia, Spain

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Gothenburg, , Sweden

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Basel, Canton of Basel-City, Switzerland

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Bern, Canton of Bern, Switzerland

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Sankt Gallen, Canton of St. Gallen, Switzerland

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Sheffield, South Yorkshire, United Kingdom

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Aberdeen, , United Kingdom

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Dundee, , United Kingdom

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Countries

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

References

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Kappos L, Edan G, Freedman MS, Montalban X, Hartung HP, Hemmer B, Fox EJ, Barkhof F, Schippling S, Schulze A, Pleimes D, Pohl C, Sandbrink R, Suarez G, Wicklein EM; BENEFIT Study Group. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology. 2016 Sep 6;87(10):978-87. doi: 10.1212/WNL.0000000000003078. Epub 2016 Aug 10.

Reference Type DERIVED
PMID: 27511182 (View on PubMed)

Related Links

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http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

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2012-005262-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16401

Identifier Type: -

Identifier Source: org_study_id

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