The OCREVUS RMS patient 8
OCREVUS was studied for 2 years with an additional 2 years of open-label extension (OLE)
Patient demographics reflect the OCREVUS patient at trial baseline
and the Rebif patient at OLE initiation.
Controlled-period design: Two randomized, double-blind, double-dummy, active comparator-controlled clinical trials of identical design vs Rebif® (interferon β-1a) in 1656 patients (OCREVUS; OPERA I [n=410], OPERA II [n=417]; Rebif; OPERA I [n=411], OPERA II [n=418]) with RMS treated for 96 weeks. Both studies included patients who had experienced ≥1 relapse within the prior year, or 2 relapses within the prior 2 years, and had an EDSS score between 0 and 5.5. The primary outcome of both studies was the annualized relapse rate. 8
OLE-period design: Patients who completed the OPERA trials in either treatment arm (OCREVUS or Rebif) were permitted to enter the OLE after a 4-week screening period. Patients who received Rebif during the controlled period continued to receive Rebif during the OLE screening period until their first infusion of OCREVUS. In the OLE phase, the first 600 mg dose of OCREVUS was administered as two 300 mg infusions given 2 weeks apart. 8
OLE=open-label extension; EDSS=Expanded Disability Status Scale.
Well-balanced studies of RMS patients
RMS Patient Demographics 1,2