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History of Changes for Study: NCT00544037
BENEFIT Extension Study
Latest version (submitted March 2, 2012) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 15, 2007 None (earliest Version on record)
2 November 9, 2007 Eligibility, Study Status, Study Design and Oversight
3 September 26, 2008 Contacts/Locations, Study Status, Study Identification, Groups and Interventions, Study Design, Study Description and Sponsor/Collaborators
4 September 29, 2008 Study Status
5 October 27, 2008 Contacts/Locations, Study Status and Sponsor/Collaborators
6 November 28, 2008 Study Status and Contacts/Locations
7 January 9, 2009 Study Status
8 January 13, 2009 Outcome Measures and Study Status
9 February 23, 2009 Contacts/Locations and Study Status
10 March 4, 2009 Study Status
11 March 26, 2009 Study Status and Contacts/Locations
12 April 24, 2009 Study Status and Contacts/Locations
13 May 25, 2009 Contacts/Locations and Study Status
14 June 29, 2009 Study Status and Contacts/Locations
15 July 3, 2009 Study Status
16 August 31, 2009 Study Status
17 October 1, 2009 Study Status
18 January 22, 2010 Contacts/Locations, Study Status and Outcome Measures
19 February 10, 2010 Study Status
20 March 16, 2010 Contacts/Locations, Study Status, Outcome Measures and Study Design
21 April 15, 2010 Contacts/Locations, Study Status, Outcome Measures and Study Design
22 July 20, 2010 Study Status and Eligibility
23 September 24, 2010 Contacts/Locations, Groups and Interventions, Study Status, Eligibility, Study Design and Sponsor/Collaborators
24 October 19, 2010 Study Status
25 November 19, 2010 Study Status and Contacts/Locations
26 December 21, 2010 Study Status
27 January 21, 2011 Study Status and Contacts/Locations
28 February 22, 2011 Study Status and Contacts/Locations
29 March 16, 2011 Recruitment Status, Study Status, Contacts/Locations and Study Design
30 March 2, 2012 Study Status, Study Identification and Sponsor/Collaborators
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Study NCT00544037
Submitted Date:  October 15, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: 311129
Brief Title: BENEFIT Extension Study
Official Title: Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2007
Overall Status: Recruiting
Study Start: September 2007
Primary Completion:
Study Completion:
First Submitted: October 15, 2007
First Submitted that
Met QC Criteria:
October 15, 2007
First Posted: October 16, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 15, 2007
Last Update Posted: October 16, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bayer
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: Comparison between early treatment with IFNB-1b (initiated after the first event, i.e. IFNB-1b group of study 304747)and delayed IFNB-1b treatment (initiated after the development of CDMS or after two years, whichever comes first i.e. placebo group of study 304747)
Detailed Description:
Open or close this module Conditions
Conditions: Multiple Sclerosis
Keywords:
Open or close this module Study Design
Study Type: Observational
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 468 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 23 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • All patients randomized and treated at least once in study 304747

Exclusion Criteria:

  • Medical, psychhiatric or other conditions that compromise the patient's ability to understand the purpose of the study
Open or close this module Contacts/Locations
Central Contact Person: Bayer Clinical Trials Contact
Email: clinical-trials-contact@bayerhealthcare.com
Study Officials: Bayer Study Manager
Study Director
Bayer
Locations: Austria
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Austria
Belgium
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Belgium
Canada
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Canada
Czech Republic
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Czech Republic
Denmark
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Denmark
Finland
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Finland
France
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, France
Germany
Bayer Clinical Research Center
[Recruiting]
Ask Contact, Germany
Hungary
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Hungary
Israel
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Israel
Italy
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Italy
Netherlands
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Netherlands
Norway
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Norway
Poland
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Poland
Portugal
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Portugal
Slovenia
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Slovenia
Spain
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Spain
Sweden
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Sweden
Switzerland
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, Switzerland
United Kingdom
Bayer Clinical Research Center
[Not yet recruiting]
Ask Contact, United Kingdom
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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