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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related Quality of Life [ Time Frame: At baseline and at Month 24 ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: At baseline and at Month 24 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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

  Hide Study Locations
Locations
Australia
Many Locations, Australia
Austria
Many Locations, Austria
Bahrain
Many Locations, Bahrain
Belgium
Many Locations, Belgium
Canada
Many Locations, Canada
Colombia
Many Locations, Colombia
Czech Republic
Many Locations, Czech Republic
Denmark
Many Locations, Denmark
Egypt
Many Locations, Egypt
France
Many Locations, France
Germany
Many Locations, Germany
Greece
Many Locations, Greece
Indonesia
Many Locations, Indonesia
Israel
Many Locations, Israel
Italy
Many Locations, Italy
Jordan
Many Locations, Jordan
Kazakhstan
Many Locations, Kazakhstan
Korea, Republic of
Many Locations, Korea, Republic of
Kuwait
Many Locations, Kuwait
Lebanon
Many Locations, Lebanon
Mexico
Many Locations, Mexico
Netherlands
Many Locations, Netherlands
Norway
Many Locations, Norway
Oman
Many Locations, Oman
Portugal
Many Locations, Portugal
Slovenia
Many Locations, Slovenia
Spain
Many Locations, Spain
Sweden
Many Locations, Sweden
Switzerland
Many Locations, Switzerland
Taiwan
Many Locations, Taiwan
Thailand
Many Locations, Thailand
United Arab Emirates
Many Locations, United Arab Emirates
United Kingdom
Many Locations, United Kingdom
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

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
Health Authority: Australia: Human Research Ethics Committee
Belgium: Ethics Committee
Canada: Ethics Review Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Comité National de l'Ordre des Médecins = CNOM
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Greece: National Organization of Medicines
Israel: Ethics Commission
Italy: Ethics Committee
Kazakhstan: National Center for Expertise of Medicinal Drugs
Lebanon: Institutional Review Board
Mexico: Ethics Committee
Norway:National Committee for Medical and Health Research Ethics
Portugal: National Committee for Data Protection (CNPD)
Portugal: Health Ethic Committee
Portugal: National Pharmacy and Medicines Institute
South Korea: Korea Food and Drug Administration (KFDA)
Slovenia: Ethics Committee
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Regional Health Authorities
Spain: Ethics Committee
Spain: Spanish Agency of Medicines
Sweden: Regional Ethical Review Board
Taiwan: Institutional Review Board
Taiwan: Local Ethics Committees
Thailand: Ethical Committee
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Bayer:
Physical Activity
Fatigue
RRMS
CIS

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

ClinicalTrials.gov processed this record on October 23, 2014