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Physical Activity and Fatigue in Early Multiple Sclerosis (MS) (BEGIN)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 16, 2009
Last Update Posted: May 30, 2012
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.
Information provided by:
The purpose of this observational study is to obtain a survey on physical activity in patients who for the first time have experienced symptoms which indicate a high risk for developing multiple sclerosis (MS) and in patients with recently diagnosed MS, and to obtain information on factors potentially influencing the patients' level of activity.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Betaferon Treatment and Exercise Data Gathering IN Early MS

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Physical Activity and Fatigue [ Time Frame: At baseline and at Month 24 ]

Secondary Outcome Measures:
  • Health-related Quality of Life [ Time Frame: At baseline and at Month 24 ]
  • Depression [ Time Frame: At baseline and at Month 24 ]

Biospecimen Retention:   None Retained

Enrollment: 1739
Study Start Date: August 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Intravenous therapy according to product information


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients after a first demyelinating event suggestive of MS as well as patients with recently diagnosed RRMS (< 12 months)

Inclusion Criteria:

  • Multiple sclerosis diagnosed within the last 12 months
  • Clinically isolated Syndrome (CIS), under Interferon-beta-1b treatment
  Contacts and Locations
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): NCT00882453

  Show 33 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Regional Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00882453     History of Changes
Other Study ID Numbers: 13853
BF0601 ( Other Identifier: company internal )
310721 ( Other Identifier: company internal )
First Submitted: April 15, 2009
First Posted: April 16, 2009
Last Update Posted: May 30, 2012
Last Verified: May 2012

Keywords provided by Bayer:
Physical Activity

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic