At a glance
ClinicalIndex Comparison Record- ✓Completed BENEFIT trial (either by developing CDMS or by 24-month mark)
- ✕Did not participate in the initial BENEFIT study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months.
In Brief
A Phase 3 clinical trial evaluating Interferon beta-1b (Betaseron, BAY86-5046) for Multiple Sclerosis. Completed, enrolled 468 participants across 94 sites in 20 countries.
Detailed 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.
Study Details
Timeline
Interventions
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 treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)