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BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00185211
First received: September 9, 2005
Last updated: December 4, 2013
Last verified: December 2013
Results First Received: July 23, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Intervention: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The full analysis set includes all 468 participants (particip.) with at least one administration of study drug in the placebo-controlled original study 92012, using treatment groups as randomized according to the minimization procedure regardless of the kind of study treatment (IFNB-1b/placebo) received. 19 subjects did not consent to the Follow-up

Reporting Groups
  Description
Initial IFNB-1b (Interferon Beta-1b) Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
Initial Placebo Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)

Participant Flow for 2 periods

Period 1:   Placebo-controlled Study (92012)
    Initial IFNB-1b (Interferon Beta-1b)   Initial Placebo
STARTED   292   176 
COMPLETED   271   166 
NOT COMPLETED   21   10 
Adverse Event                8                0 
Lost to Follow-up                3                2 
Withdrawal by Subject                9                7 
fulfilled local def. and McDonald crit.                0                1 
Adverse event, then subject's withdrawal                1                0 

Period 2:   Follow-up Study (91031 - This Study)
    Initial IFNB-1b (Interferon Beta-1b)   Initial Placebo
STARTED   261 [1]   157 [2] 
COMPLETED   235   123 
NOT COMPLETED   26   34 
Adverse Event                5                6 
Lack of Efficacy                1                0 
Lost to Follow-up                6                4 
Physician Decision                1                0 
Pregnancy                0                1 
Withdrawal by Subject                13                21 
other disease modif. treatment                0                2 
[1] 10 of the 271 subjects completing the placebo-controlled study did not consent to the Follow-up.
[2] 9 of the 166 subjects completing the placebo-controlled study did not consent to the Follow-up.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Initial IFNB-1b (Interferon Beta-1b) Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
Initial Placebo Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
Total Total of all reporting groups

Baseline Measures
   Initial IFNB-1b (Interferon Beta-1b)   Initial Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 292   176   468 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.8  (7.6)   30.7  (7.1)   30.7  (7.4) 
Gender 
[Units: Participants]
     
Female   207   124   331 
Male   85   52   137 
Number of T2 lesions detected in screening MRI (Magnet-Resonance Imaging) [1] 
[Units: Participants]
     
2 to 4 T2 lesions   42   25   67 
5 to 8 T2 lesions   43   28   71 
at least 9 T2 lesions   207   123   330 
[1] Only patients with at least two clinically silent lesions on the T2-weighted brain MRI scan with a size of at least 3 mm, at least one of which is ovoid or periventricular or infratentorial, were included. Number of T2 lesions with the three categories was used in the minimization procedure.
Number of participants with steroid use during the first clinical demyelinating event [1] 
[Units: Participants]
     
Steroid Use   209   123   332 
No Steroid Use   83   53   136 
[1] The allocation of participants to the treatment arms was according to a minimization procedure with an element of randomization to minimize imbalances of treatment groups with respect to e.g. steroid use during first clinical demyelinating event. Steroid treatment was at the discretion of the investigator.
Type of onset of disease (classification of first demyelinating event) [1] 
[Units: Participants]
     
monofocal disease   153   93   246 
multifocal disease   139   83   222 
[1] On the basis of the central classification of the patient’s symptoms and signs, the first event was classified as either monofocal (a single central nervous system (CNS) lesion suffices to explain the patient’s symptoms and signs) or multifocal (the patient’s symptoms and signs can only be explained by multiple (i.e. more than one) CNS lesions.


  Outcome Measures
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1.  Primary:   Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With CDMS at Selected Points in Time   [ Time Frame: up to 60 months after start of treatment ]

2.  Primary:   Time to Confirmed Expanded Disability Status Scale (EDSS) Progression Represented by Kaplan-Meier Estimates of the Cumulative Percentage of Participants With Confirmed EDSS Progression at Selected Points in Time   [ Time Frame: up to 60 months after start of treatment ]

3.  Primary:   Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60   [ Time Frame: 60 months after start of treatment ]

4.  Secondary:   Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald Criteria   [ Time Frame: up to 60 months after start of treatment ]

5.  Secondary:   Relapse-based Efficacy Domain: Hazard Ratio for Recurrent Relapses   [ Time Frame: up to 60 months after start of treatment ]

6.  Secondary:   Relapse-based Efficacy Domain (Supportive): Annualized Relapse Rate   [ Time Frame: up to 60 months after start of treatment ]

7.  Secondary:   Disability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60   [ Time Frame: 60 months after start of treatment ]

8.  Secondary:   MRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60   [ Time Frame: up to 60 months after start of treatment ]

9.  Secondary:   MRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60   [ Time Frame: 60 months after start of treatment ]

10.  Secondary:   MRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60   [ Time Frame: 60 months after start of treatment ]

11.  Secondary:   MRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60   [ Time Frame: 60 months after start of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Participant Flow: Subject with "Other" as reason for not completing a study period are presented according to the NIH pre-specified categories as far as possible.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


Publications of Results:

Other Publications:

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00185211     History of Changes
Other Study ID Numbers: 91031
305207 ( Other Identifier: Company Internal )
Study First Received: September 9, 2005
Results First Received: July 23, 2009
Last Updated: December 4, 2013