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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00882453




Registration number
NCT00882453
Ethics application status
Date submitted
15/04/2009
Date registered
16/04/2009
Date last updated
30/05/2012

Titles & IDs
Public title
Physical Activity and Fatigue in Early Multiple Sclerosis (MS)
Scientific title
Betaferon Treatment and Exercise Data Gathering IN Early MS
Secondary ID [1] 0 0
BF0601
Secondary ID [2] 0 0
13853
Universal Trial Number (UTN)
Trial acronym
BEGIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Interferon beta-1b (Betaseron, BAY86-5046)

Group 1 -


Treatment: Drugs: Interferon beta-1b (Betaseron, BAY86-5046)
Intravenous therapy according to product information
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Physical Activity and Fatigue
Timepoint [1] 0 0
At baseline and at Month 24
Secondary outcome [1] 0 0
Health-related Quality of Life
Timepoint [1] 0 0
At baseline and at Month 24
Secondary outcome [2] 0 0
Depression
Timepoint [2] 0 0
At baseline and at Month 24

Eligibility
Key inclusion criteria
- Multiple sclerosis diagnosed within the last 12 months

- Clinically isolated Syndrome (CIS), under Interferon-beta-1b treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
1739
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Many Locations
Recruitment postcode(s) [1] 0 0
- Many Locations
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Many Locations
Country [2] 0 0
Bahrain
State/province [2] 0 0
Many Locations
Country [3] 0 0
Belgium
State/province [3] 0 0
Many Locations
Country [4] 0 0
Canada
State/province [4] 0 0
Many Locations
Country [5] 0 0
Colombia
State/province [5] 0 0
Many Locations
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Many Locations
Country [7] 0 0
Denmark
State/province [7] 0 0
Many Locations
Country [8] 0 0
Egypt
State/province [8] 0 0
Many Locations
Country [9] 0 0
France
State/province [9] 0 0
Many Locations
Country [10] 0 0
Germany
State/province [10] 0 0
Many Locations
Country [11] 0 0
Greece
State/province [11] 0 0
Many Locations
Country [12] 0 0
Indonesia
State/province [12] 0 0
Many Locations
Country [13] 0 0
Israel
State/province [13] 0 0
Many Locations
Country [14] 0 0
Italy
State/province [14] 0 0
Many Locations
Country [15] 0 0
Jordan
State/province [15] 0 0
Many Locations
Country [16] 0 0
Kazakhstan
State/province [16] 0 0
Many Locations
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Many Locations
Country [18] 0 0
Kuwait
State/province [18] 0 0
Many Locations
Country [19] 0 0
Lebanon
State/province [19] 0 0
Many Locations
Country [20] 0 0
Mexico
State/province [20] 0 0
Many Locations
Country [21] 0 0
Netherlands
State/province [21] 0 0
Many Locations
Country [22] 0 0
Norway
State/province [22] 0 0
Many Locations
Country [23] 0 0
Oman
State/province [23] 0 0
Many Locations
Country [24] 0 0
Portugal
State/province [24] 0 0
Many Locations
Country [25] 0 0
Slovenia
State/province [25] 0 0
Many Locations
Country [26] 0 0
Spain
State/province [26] 0 0
Many Locations
Country [27] 0 0
Sweden
State/province [27] 0 0
Many Locations
Country [28] 0 0
Switzerland
State/province [28] 0 0
Many Locations
Country [29] 0 0
Taiwan
State/province [29] 0 0
Many Locations
Country [30] 0 0
Thailand
State/province [30] 0 0
Many Locations
Country [31] 0 0
United Arab Emirates
State/province [31] 0 0
Many Locations
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Many Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00882453
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00882453