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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00882453
First received: April 15, 2009
Last updated: May 28, 2012
Last verified: May 2012
  Purpose
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
n.a

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

  Eligibility

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)
Criteria

Inclusion Criteria:

  • Multiple sclerosis diagnosed within the last 12 months
  • Clinically isolated Syndrome (CIS), under Interferon-beta-1b treatment
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882453

  Show 33 Study Locations
Sponsors and Collaborators
Bayer
Investigators
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  310721 
Study First Received: April 15, 2009
Last Updated: May 28, 2012

Keywords provided by Bayer:
Physical Activity
Fatigue
RRMS
CIS

Additional relevant MeSH terms:
Sclerosis
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
Interferon-beta
Interferons
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 17, 2017