Table 1.

Completed ocrelizumab in MS trials to date, with details on trial design and significant results

Trial	Phase	Design	Population	Sample Size	Ocrelizumab Dosage	Duration	Outcomes	Adverse Events
NCT0067671557	II	Randomized, double-blind, placebo-controlled	RRMS	220	600 mg (given at 300 mg 2W apart) first cycle, then 600 mg second cycle 2,000 mg (given as 1,000 mg 2W apart) first cycle, then 1,000 mg second cycle	48 weeks	• 80% and 73% reduction in ARR for 600 mg and 2,000 mg, respectively • 89% and 96% reduction in # of GEL for 600 mg and 2,000 mg, respectively	• 47%–66% experienced AE • 2% in 600 mg group experienced serious AE vs 4%–6% in 2,000 mg group • 35% and 44% experienced IRR in 600 mg and 2,000 mg, respectively • No opportunistic infections
OPERA I/II108	III	Randomized, double-blind, IFNβ-1a controlled	RRMS	821 + 835	600 mg IV Q24W	96 weeks	• 46% and 47% reduction in ARR • 43% and 37% risk reduction to CDP at 12 and 24 weeks • 94% and 95% reduction in # of GEL • 77% and 83% reduction in # of new/enlarging T2 lesions	• 83.3% experienced AE • 6.9% serious AE • IRR most common AE (34.3%) • No significant difference to IFN
ORATORIO110	III	Randomized, double-blind, placebo-controlled	PPMS	732	600 mg IV Q24W (given as 300 mg 2W apart)	120 weeks	• 24% and 25% risk reduction of CDP for 12 and 24 weeks, respectively • 3.4% decrease in T2 lesion volume • 17.5% reduced rate of brain atrophy	• 20.4% serious AE • IRR most common AE (39.9%) • No significant difference to placebo

Abbreviations: AE, adverse event; IV, intravenous; ARR, annualized relapse rate; RRMS, relapsing–remitting multiple sclerosis; GEL, gadolinium-enhancing lesions; CDP, confirmed disability progression; PPMS, primary-progressive multiple sclerosis; Q24W, every 24 weeks; 2W, 2 weeks; IRR, infusion-related reaction.