Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
Brief Summary: This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.

The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.


Options:
A: Relapse Rate: Number of Confirmed Relapses During the Double Blind Study Period (Up to Month 24)
B: Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks and 48 Weeks as Measured Using Expanded Disability Status Scale (EDSS) (Baseline up to 4 years); Percentage of Participants With 24-Week and 48-Week Confirmed Disability Improvement (CDI) During the Year 1 Treatment Period, as Measured Using EDSS (At Weeks 24 and 48 during Year 1); Percentage of Participants Event-Free for CDP Sustained for at Least 24 and 48 Weeks at Year 1, as Measured Using EDSS (Year 1 (Weeks 24 and 48)); Percentage of Participants With 24-Week and 48-Week CDI During the Year 2 Treatment Period, as Measured Using EDSS (At Weeks 48, 72 and 96 during Year 2); Percentage of Participants Event-free for CDP Sustained for at Least 24 and 48 Weeks at Year 2, as Measured Using EDSS (Year 2 (Weeks 72 and 96)); Percentage of Participants With 24-Week and 48-Week CDI at Year 4, as Measured Using EDSS (At Weeks 144, 168 and 192 during Year 4); Percentage of Participants Event-free for CDP Sustained for at Least 24 and 48 Weeks at Year 4, as Measured Using EDSS (Year 4 (Weeks 168 and 192)); Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS (Year 1 (Week 48)); Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS (Year 2 (Week 96)); Percentage of Participants Who Have Improved, Stable, or Worsened Disability at Year 3, As Measured Using EDSS (Year 3); Percentage of Participants Who Have Improved, Stable, or Worsened Disability at Year 4, As Measured Using EDSS (Year 4); Mean Change From Baseline in EDSS Score at Week 24 (From Baseline to Week 24); Mean Change From Baseline in EDSS Score at Week 48 (From Baseline to Week 48); Mean Change From Baseline in EDSS Score at Week 72 (From Baseline to Week 72); Mean Change From Baseline in EDSS Score at Week 96 (Baseline, Week 96); Mean Change From Baseline in EDSS Score at Week 120 (Baseline, Week 120); Mean Change From Baseline in EDSS Score at Week 144 (Baseline, Week 144); Mean Change From Baseline in EDSS Score at Week 168 (Baseline, Week 168); Mean Change From Baseline in EDSS Score at Week 192 (Baseline, Week 192); Percentage of Participants Without Protocol-Defined Event of Disease Activity (Baseline up to 4 years); Percentage of Participants Without Relapse (Baseline up to 4 years); Annualized Relapse Rate (Baseline up to 4 years); Sub Study: Number of Participants With IRRs Occurring During or Within 24 Hours Following the First Infusion After Randomization to the Shorter Infusion Substudy (Week 24 through Week 144)
C: Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core) (Month 6 (Core)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12 (Month 12 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60 (Month 60 (extension)); Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study (Last observation (Up to 80 months in average))
D: Total Number of Gadolinium-Enhancing T1 Lesions (Week 12 to Week 24)

Answer: B