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

Tracking Information
First Submitted Date April 15, 2009
First Posted Date April 16, 2009
Last Update Posted Date May 30, 2012
Study Start Date August 2006
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2009)
Physical Activity and Fatigue [ Time Frame: At baseline and at Month 24 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00882453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 15, 2009)
  • Health-related Quality of Life [ Time Frame: At baseline and at Month 24 ]
  • Depression [ Time Frame: At baseline and at Month 24 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Physical Activity and Fatigue in Early Multiple Sclerosis (MS)
Official Title Betaferon Treatment and Exercise Data Gathering IN Early MS
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
n.a
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)
Condition Multiple Sclerosis
Intervention Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Intravenous therapy according to product information
Study Groups/Cohorts Group 1
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 10, 2011)
1739
Original Estimated Enrollment
 (submitted: April 15, 2009)
1600
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Multiple sclerosis diagnosed within the last 12 months
  • Clinically isolated Syndrome (CIS), under Interferon-beta-1b treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Austria,   Bahrain,   Belgium,   Canada,   Colombia,   Czech Republic,   Denmark,   Egypt,   France,   Germany,   Greece,   Indonesia,   Israel,   Italy,   Jordan,   Kazakhstan,   Korea, Republic of,   Kuwait,   Lebanon,   Mexico,   Netherlands,   Norway,   Oman,   Portugal,   Slovenia,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   United Arab Emirates,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00882453
Other Study ID Numbers 13853
BF0601 ( Other Identifier: company internal )
310721 ( Other Identifier: company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Regional Medical Director, Bayer Healthcare AG
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date May 2012