Phase 3
Completed N=468
BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study
Source: ClinicalTrials.gov NCT00185211 ↗Enrolled (actual)
468
Serious AEs
22.0%
Results posted
Nov 2010
Primary outcomePrimary: 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 — 26.9; 45.0; 36.7; 51.2 cum. percentage of particip. with CDMS — p=0.0027
Summary
This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).
Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
26.9; 45.0; 36.7; 51.2; 46.2; 57.3 | 0.0027 sig |
| 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 |
12.8; 19.9; 16.8; 25.3; 24.9; 28.9 | 0.1768 |
| PRIMARY Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Month 60 |
125; 125 | 0.8880 |
| SECONDARY Relapse-based Efficacy Domain: Time to Multiple Sclerosis (MS) According to McDonald Criteria |
9.4; 6 | 0.000006 sig |
| SECONDARY Relapse-based Efficacy Domain: Hazard Ratio for Recurrent Relapses |
0.797 | 0.1265 |
| SECONDARY Relapse-based Efficacy Domain (Supportive): Annualized Relapse Rate |
0.2139; 0.2695 | 0.0141 sig |
| SECONDARY Disability-based Efficacy Domain: Multiple Sclerosis Functional Composite (MSFC) at Month 60 |
0.226; 0.225 | 0.6078 |
| SECONDARY MRI (Magnet-Resonance Imaging)-Based Efficacy Domain: Cumulative Number of Newly Active Lesions at Month 60 |
4; 7 | 0.0062 sig |
| SECONDARY MRI-based Efficacy Domain: Absolute Change of T2 Lesion Volume From Screening MRI to Month 60 |
-123.0; -194.5 | 0.7801 |
| SECONDARY MRI-based Efficacy Domain: Absolute Change of Volume of Black Holes From Screening MRI to Month 60 |
0; 0 | 0.6619 |
| SECONDARY MRI-based Efficacy Domain: Percentage Change of Brain Volume From Screening MRI to Month 60 |
-2.281; -1.771 | 0.1208 |
Eligibility Criteria
Inclusion Criteria
- Patients who have reached scheduled end of study in BENEFIT, either by developing CDMS or by completing 24 months
Exclusion Criteria
- No participation in the initial BENEFIT study
Data sourced from ClinicalTrials.gov (NCT00185211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.