Working… Menu

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

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. Identifier: NCT00882453
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : May 30, 2012
Information provided by:

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 1739 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Betaferon Treatment and Exercise Data Gathering IN Early MS
Study Start Date : August 2006
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Group/Cohort Intervention/treatment
Group 1 Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Intravenous therapy according to product information

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

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

Biospecimen Retention:   None Retained

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00882453

  Show 33 Study Locations
Sponsors and Collaborators
Layout table for investigator information
Study Director: Bayer Study Director Bayer

Layout table for additonal information
Responsible Party: Regional Medical Director, Bayer Healthcare AG Identifier: NCT00882453     History of Changes
Other Study ID Numbers: 13853
BF0601 ( Other Identifier: company internal )
310721 ( Other Identifier: company internal )
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: May 30, 2012
Last Verified: May 2012
Keywords provided by Bayer:
Physical Activity
Additional relevant MeSH terms:
Layout table for 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