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Last updated: 1 Mar 2016

Ocrelizumab

Summary
Trade name: 
Ocrevus
(25)
U.S. FDA grants Breakthrough Therapy Designation for Roche’s investigational medicine ocrelizumab in primary progressive multiple sclerosis
Roche, 17 Feb 2016
Accessed on 23 Feb 2016 from http://www.roche.com/investors/updates/inv-update-2016-02-17.htm.
Class: 
Immunosuppressor
(4)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Target: 
B cells
(4)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
CD20
(4)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Status for MS: 
Phase III trials
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Administration: 
Intravenous
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
(11)
A Study of Efficacy and Safety of Ocrelizumab in Patients with Relapse-Remitting Multiple Sclerosis
ClinicalTrials.gov, 14 Nov 2011
Accessed on 7 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00676715.
Commercial: 
Clinical trials have been funded by Hoffmann-La Roche Ltd and Biogen Idec
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
Genentech, a wholly-owned member of the Roche Group, is now fully responsible for development and commercialization of ocrelizumab in MS; Biogen Idec will receive royalties on sales of ocrelizumab in the US (21 October 2010)
(24)
Biogen Idec and Genentech announce restructuring of anti-CD20 collaboration agreement
Roche, 21 Oct 2010
Accessed on 3 Nov 2015 from http://www.roche.com/investors/updates/inv-update-2010-10-21b.htm.
Biogen Idec, which originally funded trials for ocrelizumab, has changed its name to Biogen (23 March 2015)
(20)
Biogen Idec Becomes Biogen
Biogen, 23 Mar 2015
Accessed on 7 Apr 2015 from http://biogen.newshq.businesswire.com/press-release/corporate/biogen-idec-becomes-biogen.
Granted Breakthrough Therapy Designation by the US Food and Drug Administration for treating PPMS; this designation aims to speed the development and review of ocrelizumab (17 February 2016)
(25)
U.S. FDA grants Breakthrough Therapy Designation for Roche’s investigational medicine ocrelizumab in primary progressive multiple sclerosis
Roche, 17 Feb 2016
Accessed on 23 Feb 2016 from http://www.roche.com/investors/updates/inv-update-2016-02-17.htm.
Names
Name: 
Ocrelizumab
Trade name: 
Ocrevus
(25)
U.S. FDA grants Breakthrough Therapy Designation for Roche’s investigational medicine ocrelizumab in primary progressive multiple sclerosis
Roche, 17 Feb 2016
Accessed on 23 Feb 2016 from http://www.roche.com/investors/updates/inv-update-2016-02-17.htm.
Synonyms: 
Ocrelizumab
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
PR070769
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
PRO-70769
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
UNII-A10SJL62JY
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
rhuMAb 2H7
(1)
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.
OCRE
(4)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Systematic name: 
Immunoglobulin G1, anti (human CD20 (antigen)) (human mouse monoclonal 2H7 γ1 chain), disulfide with human mouse monoclonal 2H7 κ chain, dimer
(2)
American Medical Association fact sheet on ocrelizumab
American Medical Aassociation
Accessed on 9 Dec 2011 from www.ama-assn.org/resources/doc/usan/ocrelizumab.doc.
Physiology
Class: 
Immunosuppressor
(4)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Target: 
B cells
(4)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
CD20
(4)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Properties: 
Humanized, recombinant, type 1 monoclonal IgG antibody
(5)
CD20-targeted therapy: a breakthrough in the treatment of non-Hodgkin's lymphoma.
van Meerten T, Hagenbeek A
Neth J Med. 2009 Jul-Aug; 67(7):251-9. PMID: 19687518. Abstract
Molecular weight, 148 kDa
(2)
American Medical Association fact sheet on ocrelizumab
American Medical Aassociation
Accessed on 9 Dec 2011 from www.ama-assn.org/resources/doc/usan/ocrelizumab.doc.

Mechanisms/Effects

Human: 
Compared to rituximab (which also targets B cells and CD20), binds to a different (but overlapping) epitope of the large extracellular loop of CD20
(4)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Depletes B cells via antibody-dependent cell-mediated toxicity (ADCC) and complement-dependent cytotoxicity (CDC)
(4)
Treating multiple sclerosis with monoclonal antibodies: a 2010 update.
Buttmann M
Expert Rev Neurother. 2010 May; 10(5):791-809. PMID: 20420497. Abstract
Compared to rituximab, induces more ADCC and less CDC, which could reduce infusion-related toxicity
(6)
New therapies in the management of rheumatoid arthritis.
Buch MH, Emery P
Curr Opin Rheumatol. 2011 May; 23(3):245-51. PMID: 21427579. Abstract
Depletes B cells in patients with rheumatoid arthritis, and B cell recovery after initial depletion is more rapid at lower doses
(17)
Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a phase I/II randomized, blinded, placebo-controlled, dose-ranging study.
Genovese MC, Kaine JL, Lowenstein MB, Del Giudice J, Baldassare A, Schechtman J, Fudman E, Kohen M, Gujrathi S, Trapp RG, et al.
Arthritis Rheum. 2008 Sep; 58(9):2652-61. PMID: 18759293. Abstract
Animal: 
Toxicology and rate of B cell recovery have been investigated in monkeys
(16)
Depletion of B cells by a humanized anti-CD20 antibody PRO70769 in Macaca fascicularis.
Vugmeyster Y, Beyer J, Howell K, Combs D, Fielder P, Yang J, Qureshi F, Sandlund B, Kawaguchi L, Dummer W, et al.
J Immunother. 2005 May-Jun; 28(3):212-9. PMID: 15838377. Abstract
Regulatory and Commercial Status
Status for MS: 
Phase III trials
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Highest status achieved (for any condition): 
Phase III
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Phase III program for rheumatoid arthritis was suspended in 2010 because of safety concerns
(10)
Roche and Biogen Idec decide to suspend Ocrelizumab treatment - Rheumatoid Arthritis development programme on hold
Roche/Biogen Idec, 8 Mar 2010
Accessed on 7 Dec 2011 from http://www.roche.com/media/media_releases/med-cor-2010-03-08.htm.
Other uses: 
Phase III trials for rheumatoid arthritis and systemic lupus erythematosus was discontinued in 2010 because of safety concerns (serious infections, some fatal, and opportunistic infections) by the Data and Safety Monitoring Board
(10)
Roche and Biogen Idec decide to suspend Ocrelizumab treatment - Rheumatoid Arthritis development programme on hold
Roche/Biogen Idec, 8 Mar 2010
Accessed on 7 Dec 2011 from http://www.roche.com/media/media_releases/med-cor-2010-03-08.htm.
In trials for B-cell lymphoma
(15)
Ocrelizumab, a humanized monoclonal antibody against CD20 for inflammatory disorders and B-cell malignancies.
Hutas G
Curr Opin Investig Drugs. 2008 Nov; 9(11):1206-15. PMID: 18951300. Abstract
A modified version of the antibody, PRO131921, with improved binding to FCγRIIIa, has been tested in relapsed or refractory chronic lymphocytic leukemia and indolent non-Hodgkins lymphoma
(5)
CD20-targeted therapy: a breakthrough in the treatment of non-Hodgkin's lymphoma.
van Meerten T, Hagenbeek A
Neth J Med. 2009 Jul-Aug; 67(7):251-9. PMID: 19687518. Abstract
Administration: 
Intravenous
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
(11)
A Study of Efficacy and Safety of Ocrelizumab in Patients with Relapse-Remitting Multiple Sclerosis
ClinicalTrials.gov, 14 Nov 2011
Accessed on 7 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00676715.
Negative effects: 
In 24-week data announced in 2010, 1.8% of the lower-dose group and 5.5% of the higher-dose group experienced serious adverse events
(14)
MS Drugs in Development: Firategrast, Ocrelizumab, and Ofatumumab
Medscape Today, 27 Oct 2010
Accessed on 7 Dec 2011 from http://www.medscape.com/viewarticle/731299.
Infusion-related reactions
(13)
Phase II Study with Ocrelizumab Shows Significant Reduction in Disease Activity for Multiple Sclerosis Patients
Genentech, 15 Oct 2010
Accessed on 7 Dec 2011 from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12987.
One patient in the high-dose group of Phase II 24-week study died of acute-onset thrombotic microangiopathy
(14)
MS Drugs in Development: Firategrast, Ocrelizumab, and Ofatumumab
Medscape Today, 27 Oct 2010
Accessed on 7 Dec 2011 from http://www.medscape.com/viewarticle/731299.
Serious opportunistic infections in rheumatoid arthritis trial
(10)
Roche and Biogen Idec decide to suspend Ocrelizumab treatment - Rheumatoid Arthritis development programme on hold
Roche/Biogen Idec, 8 Mar 2010
Accessed on 7 Dec 2011 from http://www.roche.com/media/media_releases/med-cor-2010-03-08.htm.
Commercial: 
Clinical trials have been funded by Hoffmann-La Roche Ltd and Biogen Idec
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
Genentech, a wholly-owned member of the Roche Group, is now fully responsible for development and commercialization of ocrelizumab in MS; Biogen Idec will receive royalties on sales of ocrelizumab in the US (21 October 2010)
(24)
Biogen Idec and Genentech announce restructuring of anti-CD20 collaboration agreement
Roche, 21 Oct 2010
Accessed on 3 Nov 2015 from http://www.roche.com/investors/updates/inv-update-2010-10-21b.htm.
Biogen Idec, which originally funded trials for ocrelizumab, has changed its name to Biogen (23 March 2015)
(20)
Biogen Idec Becomes Biogen
Biogen, 23 Mar 2015
Accessed on 7 Apr 2015 from http://biogen.newshq.businesswire.com/press-release/corporate/biogen-idec-becomes-biogen.
Granted Breakthrough Therapy Designation by the US Food and Drug Administration for treating PPMS; this designation aims to speed the development and review of ocrelizumab (17 February 2016)
(25)
U.S. FDA grants Breakthrough Therapy Designation for Roche’s investigational medicine ocrelizumab in primary progressive multiple sclerosis
Roche, 17 Feb 2016
Accessed on 23 Feb 2016 from http://www.roche.com/investors/updates/inv-update-2016-02-17.htm.
Key Clinical Trials
Placebo-controlled Trials: 
Trial name: 
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis (ORATORIO) (press release, September 2015; meeting abstract, February 2016)
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
(12)
Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years
Genentech, 19 Oct 2011
Accessed on 5 Dec 2011 from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13627.
(22)
Roche’s ocrelizumab first investigational medicine to show efficacy in people with primary progressive multiple sclerosis in large Phase III study
Roche, 28 Sep 2015
Accessed on 29 Sep 2015 from http://www.roche.com/media/store/releases/med-cor-2015-09-28b.htm.
(26)
Phase III study: Ocrelizumab significantly reduces disease activity in PPMS patients
News-Medical.net, 27 Feb 2016
Accessed on 1 Mar 2016 from http://www.news-medical.net/news/20160227/Phase-III-study-Ocrelizumab-significantly-reduces-disease-activity-in-PPMS-patients.aspx.
Phase: 
Phase III trial
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
Study Design: 
Company-funded, randomized, parallel-group, multicenter, multinational placebo-controlled study evaluating the efficacy and safety of ocrelizumab [600 mg (two 300 mg doses two weeks apart) via intravenous infusion every six months] on delaying the progression of disability (primary endpoint)
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
(22)
Roche’s ocrelizumab first investigational medicine to show efficacy in people with primary progressive multiple sclerosis in large Phase III study
Roche, 28 Sep 2015
Accessed on 29 Sep 2015 from http://www.roche.com/media/store/releases/med-cor-2015-09-28b.htm.
Disease Stage: 
PPMS
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
Enrollment/Number of Patients: 
732
(22)
Roche’s ocrelizumab first investigational medicine to show efficacy in people with primary progressive multiple sclerosis in large Phase III study
Roche, 28 Sep 2015
Accessed on 29 Sep 2015 from http://www.roche.com/media/store/releases/med-cor-2015-09-28b.htm.
Duration: 
120 weeks to 5.5 years
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
Status/Outcome: 
Recruitment began September 2011
(7)
A Study of Ocrelizumab in Patients with Primary Progressive Multiple Sclerosis
ClinicalTrials.gov, 17 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01194570.
; ocrelizumab delayed the progression of disability (an increase in the Expanded Disability Status Scale score that is sustained for ≥12 weeks), indicating that the trial met its primary endpoint (press release, September 2015)
(22)
Roche’s ocrelizumab first investigational medicine to show efficacy in people with primary progressive multiple sclerosis in large Phase III study
Roche, 28 Sep 2015
Accessed on 29 Sep 2015 from http://www.roche.com/media/store/releases/med-cor-2015-09-28b.htm.
; ocrelizumab reduced the risk of 12-week and 24-week confirmed disability progression by 24% and 25%, respectively; in individuals with T1 gadolinium-enhancing lesions at baseline, ocrelizumab reduced the risk of 12-week and 24-week confirmed disability progression by 35% and 33%, respectively, and in those without such lesions at baseline, the drug reduced the risk by 16% and 19% (meeting abstract, February 2016)
(26)
Phase III study: Ocrelizumab significantly reduces disease activity in PPMS patients
News-Medical.net, 27 Feb 2016
Accessed on 1 Mar 2016 from http://www.news-medical.net/news/20160227/Phase-III-study-Ocrelizumab-significantly-reduces-disease-activity-in-PPMS-patients.aspx.
Head-to-Head Trials: 
Trial name: 
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis (OPERA I) (press release, June 2015; meeting report, October 2015)
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
(12)
Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years
Genentech, 19 Oct 2011
Accessed on 5 Dec 2011 from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13627.
(21)
Genentech’s ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif®) in Two Phase III Studies in Multiple Sclerosis
Genentech, 29 Jun 2015
Accessed on 30 Jun 2015 from http://www.gene.com/media/press-releases/14597/2015-06-29/genentechs-ocrelizumab-significantly-red.
(23)
Ocrelizumab Bests Interferon in Relapsing-Remitting MS
Fiore K, MedPage Today, 9 Oct 2015
Accessed on 13 Oct 2015 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/54020.
Phase: 
Phase III trial
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
Study Design: 
Company-funded, randomized, double-blind, double-dummy parallel-group, multicenter, multinational study comparing the effect of ocrelizumab (600 mg) to interferon beta-1a on annualized relapse rate (ARR; primary endpoint); participants received either intravenous ocrelizumab (600 mg every 24 weeks) plus subcutaneous interferon beta-1a placebo 3x per week or interferon beta-1a 3x per week plus ocrelizumab placebo every 24 weeks
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
Disease Stage: 
RRMS
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
Enrollment/Number of Patients: 
Estimated enrollment, 800
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
Duration: 
96 weeks
(8)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 27 Jan 2012
Accessed on 20 Feb 2012 from http://clinicaltrials.gov/ct2/show/NCT01412333.
Status/Outcome: 
Ocrelizumab was associated with reduced ARR, disability progression, and lesion number as compared with interferon beta-1a (press release, June 2015)
(21)
Genentech’s ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif®) in Two Phase III Studies in Multiple Sclerosis
Genentech, 29 Jun 2015
Accessed on 30 Jun 2015 from http://www.gene.com/media/press-releases/14597/2015-06-29/genentechs-ocrelizumab-significantly-red.
; compared with interferon beta-1a, ocrelizumab reduced the ARR by ~50% over 2 years (0.292 versus 0.156) and slowed disease progression by a relative 40% (meeting report, October 2015)
(23)
Ocrelizumab Bests Interferon in Relapsing-Remitting MS
Fiore K, MedPage Today, 9 Oct 2015
Accessed on 13 Oct 2015 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/54020.
Trial name: 
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis (OPERA II) (press release, June 2015; meeting report, October 2015)
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
(12)
Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years
Genentech, 19 Oct 2011
Accessed on 5 Dec 2011 from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13627.
(21)
Genentech’s ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif®) in Two Phase III Studies in Multiple Sclerosis
Genentech, 29 Jun 2015
Accessed on 30 Jun 2015 from http://www.gene.com/media/press-releases/14597/2015-06-29/genentechs-ocrelizumab-significantly-red.
(23)
Ocrelizumab Bests Interferon in Relapsing-Remitting MS
Fiore K, MedPage Today, 9 Oct 2015
Accessed on 13 Oct 2015 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/54020.
Phase: 
Phase III trial
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Study Design: 
Company-funded, randomized, double-blind, double-dummy parallel-group, multicenter, multinational study comparing the effect of ocrelizumab (600 mg) to interferon beta-1a on annualized relapse rate (primary endpoint); participants received either intravenous ocrelizumab (600 mg every 24 weeks) plus subcutaneous interferon beta-1a placebo 3x per week or interferon beta-1a 3x per week plus ocrelizumab placebo every 24 weeks
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Disease Stage: 
RRMS
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Enrollment/Number of Patients: 
Estimated enrollment, 800
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Duration: 
96 weeks
(9)
A Study of Ocrelizumab in Comparison with Interferon Beta 1a (Rebif) in Patients with Relapsing Multiple Sclerosis
ClinicalTrials.gov, 1 Jun 2015
Accessed on 30 Jun 2015 from http://clinicaltrials.gov/ct2/show/NCT01247324.
Status/Outcome: 
Ocrelizumab was associated with reduced annualized relapse rate, disability progression, and lesion number as compared with interferon beta-1a (press release, June 2015)
(21)
Genentech’s ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif®) in Two Phase III Studies in Multiple Sclerosis
Genentech, 29 Jun 2015
Accessed on 30 Jun 2015 from http://www.gene.com/media/press-releases/14597/2015-06-29/genentechs-ocrelizumab-significantly-red.
; compared with interferon beta-1a, ocrelizumab reduced the ARR by ~50% over 2 years (0.290 versus 0.155) and slowed disease progression by a relative 40% (meeting report, October 2015)
(23)
Ocrelizumab Bests Interferon in Relapsing-Remitting MS
Fiore K, MedPage Today, 9 Oct 2015
Accessed on 13 Oct 2015 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/54020.
Trial name: 
Kappos et al., Lancet, November 2011 trial
(11)
A Study of Efficacy and Safety of Ocrelizumab in Patients with Relapse-Remitting Multiple Sclerosis
ClinicalTrials.gov, 14 Nov 2011
Accessed on 7 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00676715.
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
Phase: 
Phase II trial
(11)
A Study of Efficacy and Safety of Ocrelizumab in Patients with Relapse-Remitting Multiple Sclerosis
ClinicalTrials.gov, 14 Nov 2011
Accessed on 7 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00676715.
(12)
Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years
Genentech, 19 Oct 2011
Accessed on 5 Dec 2011 from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13627.
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
Study Design: 
Company-funded, multicenter, randomized, parallel, double-blind, placebo-controlled trial to test the efficacy and safety of low-dose (600 mg) or high-dose (2000 mg) ocrelizumab, given in two doses on day 1 and day 15, versus interferon beta-1a (30 microg one time per week, intramuscularly); the primary outcome measure was the total number of gadolinium-enhancing T1 lesions at weeks 12, 16, 20, and 24
(11)
A Study of Efficacy and Safety of Ocrelizumab in Patients with Relapse-Remitting Multiple Sclerosis
ClinicalTrials.gov, 14 Nov 2011
Accessed on 7 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00676715.
(12)
Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years
Genentech, 19 Oct 2011
Accessed on 5 Dec 2011 from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13627.
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
Disease Stage: 
RRMS
(11)
A Study of Efficacy and Safety of Ocrelizumab in Patients with Relapse-Remitting Multiple Sclerosis
ClinicalTrials.gov, 14 Nov 2011
Accessed on 7 Dec 2011 from http://clinicaltrials.gov/ct2/show/NCT00676715.
(12)
Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years
Genentech, 19 Oct 2011
Accessed on 5 Dec 2011 from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13627.
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
Enrollment/Number of Patients: 
220 patients
(12)
Phase II Study Showed Ocrelizumab Maintained Significant Reduction in Disease Activity for Multiple Sclerosis Patients for Almost Two Years
Genentech, 19 Oct 2011
Accessed on 5 Dec 2011 from http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13627.
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
Duration: 
Initial phase, 24 weeks
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
Status/Outcome: 
At 24 weeks, the 600 mg dose of ocrelizumab was associated with an 89% reduction in the number of gadolinium-enhancing lesions as compared to placebo, and the 2000 mg dose a 96% reduction; both doses reduced the number of lesions better than interferon beta-1a
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
Other Trials: 
Trial name: 
Extension of Kappos et al., Lancet, November 2011 trial; meeting report, March 2013
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
(19)
MS research gears up for new drugs
Gever J, MedPage Today, 26 Mar 2013
Accessed on 5 Apr 2013 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/38102.
Phase: 
Extension of Phase II trial
(19)
MS research gears up for new drugs
Gever J, MedPage Today, 26 Mar 2013
Accessed on 5 Apr 2013 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/38102.
Study Design: 
Patients originally received placebo, low-dose (600 mg), or high-dose (2000 mg) ocrelizumab, given in two doses on day 1 and day 15, or interferon beta-1a (30 microg one time per week, intramuscularly); from week 24 through 72, patients who had received placebo, interferon beta-1a, or 600 mg ocrelizumab were given 600 mg ocrelizumab every 24 weeks, whereas those who had received 2000 mg ocrelizumab were given 1000 mg every 24 weeks; from week 73 to 96, all patients were given the 600 mg per 24 weeks dose; for the final 48 weeks, no drug was given
(18)
Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial.
Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, et al.
Lancet. 2011 Nov 19; 378(9805):1779-87. Epub 2011 Oct 31. PMID: 22047971. Abstract
(19)
MS research gears up for new drugs
Gever J, MedPage Today, 26 Mar 2013
Accessed on 5 Apr 2013 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/38102.
Disease Stage: 
RRMS
(19)
MS research gears up for new drugs
Gever J, MedPage Today, 26 Mar 2013
Accessed on 5 Apr 2013 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/38102.
Enrollment/Number of Patients: 
Of the original 218 patients, 168 remained in the study for the full 144 weeks
(19)
MS research gears up for new drugs
Gever J, MedPage Today, 26 Mar 2013
Accessed on 5 Apr 2013 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/38102.
Duration: 
144 weeks
(19)
MS research gears up for new drugs
Gever J, MedPage Today, 26 Mar 2013
Accessed on 5 Apr 2013 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/38102.
Status/Outcome: 
Gadolinium-enhancing lesion numbers were reduced to zero by week 48, and stayed at zero through week 120, in the patients receiving either dose of ocrelizumab (from mean levels of 1.5 to 4 in the four original groups of patients); lesion number rose to a mean of 0.3 in the final scan; adjusted annualized relapse rates, weeks 96 to 144, were as follows: 0.116 (original placebo group); 0.082 (original low-dose ocrelizumab group); 0.352 (original high-dose ocrelizumab group); 0.076 (original interferon beta-1a group)
(19)
MS research gears up for new drugs
Gever J, MedPage Today, 26 Mar 2013
Accessed on 5 Apr 2013 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/38102.
References
ChemIDplus Advanced
United States National Library of Medicine
Accessed on 29 Jul 2013 from http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp.

Note: Compound name must be entered under "Substance Identification" and then "Names and Synonyms" selected to view synonyms.

MS research gears up for new drugs
Gever J, MedPage Today, 26 Mar 2013
Accessed on 5 Apr 2013 from http://www.medpagetoday.com/clinical-context/MultipleSclerosis/38102.
Biogen Idec Becomes Biogen
Biogen, 23 Mar 2015
Accessed on 7 Apr 2015 from http://biogen.newshq.businesswire.com/press-release/corporate/biogen-idec-becomes-biogen.
DOI: 
doi/10.7493/msdf.10.550.1