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BENEFIT Extension Study

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: NCT00544037
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : March 5, 2012
Sponsor:
Information provided by:
Bayer

Tracking Information
First Submitted Date October 15, 2007
First Posted Date October 16, 2007
Last Update Posted Date March 5, 2012
Study Start Date September 2007
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2010)
To obtain further clinical data of patients with a first demyelinating event suggestive of Multiple Sclerosis enrolled in the BENEFIT Study [ Time Frame: End of Study ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Brief Summary To assess the long-term effects of early therapeutic intervention, i.e. within two years following a first clinical demyelinating event suggestive of MS.
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:
Population of Benefit Studies
Sampling Method Non-Probability Sample
Study Population This observational study may include all patients who were randomized into and treated at least once in the BENEFIT study 304747, inclusive of patients who prematurely discontinued study participation in either study 304747 or study 305207, and patients who did not transfer from study 304747 to study 305207.
Condition Multiple Sclerosis
Intervention Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Standard Therapy for Multiple Sclerosis
Study Groups/Cohorts Group 1
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)
Publications * Nagtegaal GJ, Pohl C, Wattjes MP, Hulst HE, Freedman MS, Hartung HP, Miller D, Montalban X, Kappos L, Edan G, Pleimes D, Beckman K, Stemper B, Polman CH, Sandbrink R, Barkhof F. Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. Mult Scler. 2014 Feb;20(2):234-42. doi: 10.1177/1352458513494491. Epub 2013 Jul 10.

*   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: March 16, 2011)
283
Original Estimated Enrollment
 (submitted: October 15, 2007)
468
Actual Study Completion Date January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Medical, psychiatric or other conditions that compromise the patient's ability to understand the purpose of the study
Sex/Gender
Sexes Eligible for Study: All
Ages 23 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   Norway,   Poland,   Slovenia,   Spain,   Sweden,   Switzerland
Removed Location Countries Portugal,   United Kingdom
 
Administrative Information
NCT Number NCT00544037
Other Study ID Numbers 91713
311129 ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Global Medical Affairs Therapeutic Area Head, Byer Healthcare AG
Original Responsible Party Not Provided
Current Study Sponsor Bayer
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date March 2012