BENEFIT Extension Study

• ClinicalTrials.gov Identifier: NCT00544037
• Recruitment Status: Completed
• First Posted: October 16, 2007
• Last Update Posted: March 5, 2012
• Sponsor: Bayer
• 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
• 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.

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