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BENEFIT Extension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00544037
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : March 5, 2012
Sponsor:
Information provided by:
Bayer

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

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Study Design
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Study Type : Observational
Actual Enrollment : 283 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis
Study Start Date : September 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Standard Therapy for Multiple Sclerosis


Outcome Measures
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Primary Outcome Measures :
  1. To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study [ Time Frame: End of Study ]

Biospecimen Retention:   None Retained
Population of Benefit Studies

Eligibility Criteria
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Ages Eligible for Study:   23 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This observational study may include all patients who were randomized into and treated at least once in the BENEFIT study 304747, inclusive of patients who prematurely discontinued study participation in either study 304747 or study 305207, and patients who did not transfer from study 304747 to study 305207.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544037


Locations
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Austria
Many Locations, Austria
Belgium
Many Locations, Belgium
Canada
Many Locations, Canada
Czech Republic
Many Locations, Czech Republic
Denmark
Many Locations, Denmark
Finland
Many Locations, Finland
France
Many Locations, France
Germany
Many Locations, Germany
Hungary
Many Locations, Hungary
Israel
Many Locations, Israel
Italy
Many Locations, Italy
Netherlands
Many Locations, Netherlands
Norway
Many Locations, Norway
Poland
Many Locations, Poland
Slovenia
Many Locations, Slovenia
Spain
Many Locations, Spain
Sweden
Many Locations, Sweden
Switzerland
Many Locations, Switzerland
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Global Medical Affairs Therapeutic Area Head, Byer Healthcare AG
ClinicalTrials.gov Identifier: NCT00544037    
Other Study ID Numbers: 91713
311129 ( Other Identifier: Company internal )
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: March 5, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Interferons
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic