Relapsing Multiple SclerorsisPhase 3NCT02688985

Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)

A Phase 3 study testing Ocrelizumab, Lumbar Puncture and Methyloprednisolone in people with Relapsing Multiple Sclerorsis and Multiple Sclerosis, Primary Progressive, run by Genentech, Inc. at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Relapsing Multiple Sclerorsis, Multiple Sclerosis, Primary Progressive
What is being tested?: Ocrelizumab, Lumbar Puncture and Methyloprednisolone
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 131 participants
Where: 17 sitesin 4 countries
Study dates: 29 Apr 2016to 11 Apr 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

General Inclusion Criteria:
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1 percent (%) per year during the treatment period and for at least 24 weeks after the last dose of study treatment or until their B-cells have repleted, whichever is longer
Diagnosis of RMS in accordance with the 2010 revised McDonald criteria
Expanded Disability Status Scale (EDSS) score of 0 to 5.5 points, inclusive, at Screening
Disease duration from the onset of multiple sclerosis symptoms less than (<) 15 years in participants with an EDSS score greater than (>) 5.0 at Screening
Either treatment-naive or receiving treatment with disease-modifying therapies, including prior use of interferon (IFN)-beta-1a (Avonex®, Rebif®), IFN-beta-1b (Betaseron®/Betaferon), or glatiramer acetate (Copaxone®).

Show all 15Show fewer

At least one clinically documented relapse in the past year and/or at least one T1-weighted Gadolinium (Gd)-enhancing lesion in the past year and/or at least one new T2 lesion in the past year at the time of enrollment
Inclusion Criteria Specific to RMS Cohort Arm 4 Participants:
Must meet inclusion criteria for the RMS cohort
Separate signed Informed Consent Form for the RMS Delayed Time to Start Control Arm (Arm 4)
Must be willing to remain on the same dose and regimen of current standard of care, or no treatment if treatment-naïve, for 12 weeks after study enrollment The treating and/or study physician must agree that the participant is eligible to remain on the same dose and regimen of their current standard of care at Screening, or to receive no treatment if the participant is treatment-naïve, for 12 weeks after study enrollment
Diagnosis of PPMS in accordance with the 2010 revised McDonald criteria
EDSS score of 3.0 - 6.5 points, inclusive, at Screening
Disease duration from the onset of multiple sclerosis symptoms <10 years in participants with an EDSS at Screening less than or equal to (</=) 5.0
Documented history of either elevated immunoglobulin G (IgG) Index or one or more IgG oligoclonal bands (OCBs) detected by isoelectric focusing

Who cannot join

Diagnosis of secondary progressive multiple sclerosis without relapses for at least 1 year
History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, tuberculosis)
History of recurrent aspiration pneumonia requiring antibiotic therapy
History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved with documented clean margins on pathology)
History of or currently active primary or secondary immunodeficiency
History of coagulation disorders

Show all 25Show fewer

History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
History of alcohol or other drug abuse within 24 weeks prior to enrollment
Known presence or history of other neurologic disorders Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including chronic obstructive pulmonary disease), renal, hepatic, endocrine, gastrointestinal, or any other significant disease
Congestive heart failure (according to New York Heart Association III or IV functional severity)
Known active bacterial, viral, fungal, mycobacterial infection, or any major episode of infection requiring hospitalization or treatment with IV antibiotics
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Contraindications or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label
Contraindication for LP
Previous treatment with B cell-targeted therapies (such as rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
Previous treatment with natalizumab/Tysabri®, alemtuzumab, anti-CD4 agents, cladribine, teriflunomide, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
Treatment with fingolimod/Gilenya®, dimethyl fumarate/Tecfidera®, or similar treatment within 6 months prior to enrollment
Receipt of a live vaccine within 6 weeks prior to enrollment
Systemic corticosteroid therapy within 4 weeks prior to Baseline
Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for multiple sclerosis (such as treatment for chronic cerebrospinal venous insufficiency)
Certain laboratory abnormalities or findings at Screening
Inability to complete an MRI
Lack of peripheral venous access
Pregnant or lactating, or intending to become pregnant during the study
Diagnosis of PPMS or secondary progressive multiple sclerosis without relapses

Trial locations and contacts

17 sites in 4 countries.

Country

City, postcode or hospital

17 sites in 4 countries

United States12 sites

University Of Colorado
Aurora, Colorado, 80045
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Ohio State University
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-0001
Empire Neurology, PC
Latham, New York, 12210
Yale University School of Medicine ; Pulmonary & Critical Care
New Haven, Connecticut, 06510
Weill Cornell MC-NY Presbyter; Dept. of Neurology/Neuroscience, Judith Jaffe Multiple Sclerosis Ctr
New York, New York, 63110
Oklahoma Medical Research Foundation; MS Center of Excellence
Oklahoma City, Oklahoma, 73104
Stanford University
Palo Alto, California, 94303
University of California at San Francisco
San Francisco, California, 94115
Washington University; Wash Uni. Sch. Of Med
St Louis, Missouri, 63110
University of Massachusetts Medical School
Worcester, Massachusetts, 01655

Other trials in United States

Canada2 sites

McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal, Quebec, H3A 2B4
University of British Columbia Hospital Site; Djavad Mowafaghian Centre for Brain Health
Vancouver, British Columbia, V6T 1Z3

Other trials in Canada

Germany2 sites

Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37075

Other trials in Germany

Sweden1 site

Karolinska Universitetssjukhuset, Solna
Stockholm, 113 41

Other trials in Sweden

About this study

Official title: An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis

This is an open-label, multicenter, biomarker study designed to be hypothesis-generating in order to better understand the mechanism of action of ocrelizumab and B-cell biology in RMS or PPMS. The study will be conducted in two cohorts i.e. RMS cohort (4 arm group) and PPMS cohort (one arm group). RMS cohort: Ocrelizumab will be administered as two intravenous (IV) infusions of 300 milligrams (mg) on Days 1 and 15. Subsequent doses will be given as single 600-mg infusions at Weeks 24 and 48. Participants will be randomized in 1:1:1 ratio to receive lumbar puncture (LP) post-treatment at Week 12, 24, or 52 following the first dose of ocrelizumab in three arm groups. A fourth RMS arm with delayed treatment start (Arm 4 [control group]) will not be a part of the randomization and will be recruited separately, wherein treatment with ocrelizumab will be delayed for 12 weeks from pre-treatment baseline. PPMS cohort: Ocrelizumab 600 mg will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks. Participants will receive a LP at the start of the study before dosing with ocrelizumab and second LP at Week 52 following the first dose of ocrelizumab. A long-term extension will be conducted for participants that complete the study and continue to receive ocrelizumab. Treatment with ocrelizumab in the entire study will continue for approximately 4.5 years after the first infusion.

Conditions: Relapsing Multiple Sclerorsis, Multiple Sclerosis, Primary Progressive
Being tested: Ocrelizumab, Lumbar Puncture, Methyloprednisolone, Antihistamine
Medical subject headings: Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OcrelizumabDrug
Also called RO4964913
Ocrelizumab will be administered as IV infusion.
Lumbar PunctureProcedure or surgery
Participants will receive LP as specified in individual arms. Lumbar puncture is optional at week 52, except for RMS Cohort Arm 3 and PPMS Cohort. In addition, the lumbar punctures in the Long Term Extension phase is every other year.
MethyloprednisoloneDrug
Participants will receive 100 mg of IV methylprenisolone (or an equivalent) prior to ocrelizumab infusion.
AntihistamineDrug
Participants will receive an antihistamine, such as diphenhydramine, prior to ocrelizumab infusion.

Study groups in NCT02688985
Study group	Role	What they receive
RMS Cohort Arm 1: Ocrelizumab + LP	Experimental	Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72. Receives: Drug: Ocrelizumab; Procedure: Lumbar Puncture; Drug: Methyloprednisolone; Drug: Antihistamine
RMS Cohort Arm 2: Ocrelizumab + LP	Experimental	Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72. Receives: Drug: Ocrelizumab; Procedure: Lumbar Puncture; Drug: Methyloprednisolone; Drug: Antihistamine
RMS Cohort Arm 3: Ocrelizumab + LP	Experimental	Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72. Receives: Drug: Ocrelizumab; Procedure: Lumbar Puncture; Drug: Methyloprednisolone; Drug: Antihistamine
RMS Cohort Arm 4: Ocrelizumab + LP	Experimental	Ocrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72. Receives: Drug: Ocrelizumab; Procedure: Lumbar Puncture; Drug: Methyloprednisolone; Drug: Antihistamine
PPMS Cohort: Ocrelizumab + LP	Experimental	For the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period. Receives: Drug: Ocrelizumab; Procedure: Lumbar Puncture; Drug: Methyloprednisolone; Drug: Antihistamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Levels of NfL (Neurofilament Light) in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Primary Analysis was based on following data-cut off:
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
Measured: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
Change in Number of CD19+ B Cells in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
Measured: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
Measured: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 201611 Apr 2023

First posted23 Feb 2016 (estimated)
Study start29 Apr 2016
Primary completion11 Apr 2023
Study completion11 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Relapsing Multiple SclerorsisStudies of the same condition, open and under way.
More trials run by Genentech, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 131 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02688985
Sponsor's protocol ID: ML29966
Other IDs: 2015-004616-37, 2015
Status last verified: May 2024
First submitted: 18 Feb 2016
Last updated: 4 Jun 2024
Results posted: Yes, on ClinicalTrials.gov

Publications

MacMillan EL, Russell-Schulz B, Alejo G, Harp C, Cameron B, Winger R, Jia S, Herman A, Kassam J, Waine M, Vavasour IM, Cross H, Tam R, Traboulsee AL, Carruthers R, Kolind SH. Longitudinal magnetic resonance spectroscopy study of metabolite changes over 2 years in relapsing and primary progressive multiple sclerosis treated with ocrelizumab. Mult Scler. 2026 Jun 30:13524585261456964. doi: 10.1177/13524585261456964. Online ahead of print.
PubMed 42376811

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Patients With Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis
ClinicalTrials.gov ID: NCT02688985
Acronym / sponsor ID: ML29966
Conditions: Relapsing Multiple Sclerorsis, Multiple Sclerosis, Primary Progressive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 131 participants (actual)
Lead sponsor: Genentech, Inc.Industry (pharma, biotech, devices)
Study start: 29 Apr 2016 (actual)
Primary completion: 11 Apr 2023 (actual)
Study completion: 11 Apr 2023 (actual)
First posted: 23 Feb 2016 (estimated)
Results: Posted 4 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
RMS Cohort Arm 1: Ocrelizumab + LP	Experimental	Drug: Ocrelizumab, Procedure: Lumbar Puncture, Drug: Methyloprednisolone, Drug: AntihistamineParticipants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 12. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
RMS Cohort Arm 2: Ocrelizumab + LP	Experimental	Drug: Ocrelizumab, Procedure: Lumbar Puncture, Drug: Methyloprednisolone, Drug: AntihistamineParticipants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 24. Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
RMS Cohort Arm 3: Ocrelizumab + LP	Experimental	Drug: Ocrelizumab, Procedure: Lumbar Puncture, Drug: Methyloprednisolone, Drug: AntihistamineParticipants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP before the start of dosing (Week 1, treatment baseline) with ocrelizumab and a second LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
RMS Cohort Arm 4: Ocrelizumab + LP	Experimental	Drug: Ocrelizumab, Procedure: Lumbar Puncture, Drug: Methyloprednisolone, Drug: AntihistamineOcrelizumab treatment will be delayed for 12 weeks from pre-treatment baseline. Participants with RMS will receive ocrelizumab as two 300-mg IV infusion on Days 1 and 15 then as single infusion of 600 mg on Weeks 24 and 48. Participants will receive a LP at Week -12 (pre-treatment baseline) and a second LP before the start of dosing (Week 1, treatment baseline). Participants will be asked to have an additional optional LP at Week 52. Participants that complete the study and continue to receive ocrelizumab will receive single infusions every 24 weeks starting from Week 72.
PPMS Cohort: Ocrelizumab + LP	Experimental	Drug: Ocrelizumab, Procedure: Lumbar Puncture, Drug: Methyloprednisolone, Drug: AntihistamineFor the PPMS cohort, ocrelizumab will be administered as two 300-mg IV infusions separated by 14 days at a scheduled interval of every 24 weeks during the treatment period and then as a single 600-mg dose every 24 weeks starting week 72 during the Long-Term Extension period.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (15 listed)

For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1 percent (%) per year during the treatment period and for at least 24 weeks after the last dose of study treatment or until their B-cells have repleted, whichever is longer
Diagnosis of RMS in accordance with the 2010 revised McDonald criteria
Expanded Disability Status Scale (EDSS) score of 0 to 5.5 points, inclusive, at Screening
Disease duration from the onset of multiple sclerosis symptoms less than (<) 15 years in participants with an EDSS score greater than (>) 5.0 at Screening
Either treatment-naive or receiving treatment with disease-modifying therapies, including prior use of interferon (IFN)-beta-1a (Avonex®, Rebif®), IFN-beta-1b (Betaseron®/Betaferon), or glatiramer acetate (Copaxone®).

Key exclusion criteria (25 listed)

Diagnosis of secondary progressive multiple sclerosis without relapses for at least 1 year
History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, tuberculosis)
History of recurrent aspiration pneumonia requiring antibiotic therapy
History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved with documented clean margins on pathology)
History of or currently active primary or secondary immunodeficiency

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OcrelizumabAlso: RO4964913Ocrelizumab will be administered as IV infusion.	Drug	PPMS Cohort: Ocrelizumab + LP, RMS Cohort Arm 1: Ocrelizumab + LP, RMS Cohort Arm 2: Ocrelizumab + LP, RMS Cohort Arm 3: Ocrelizumab + LP, RMS Cohort Arm 4: Ocrelizumab + LP
Lumbar PunctureParticipants will receive LP as specified in individual arms. Lumbar puncture is optional at week 52, except for RMS Cohort Arm 3 and PPMS Cohort. In addition, the lumbar punctures in the Long Term Extension phase is every other year.	Procedure or surgery	PPMS Cohort: Ocrelizumab + LP, RMS Cohort Arm 1: Ocrelizumab + LP, RMS Cohort Arm 2: Ocrelizumab + LP, RMS Cohort Arm 3: Ocrelizumab + LP, RMS Cohort Arm 4: Ocrelizumab + LP
MethyloprednisoloneParticipants will receive 100 mg of IV methylprenisolone (or an equivalent) prior to ocrelizumab infusion.	Drug	PPMS Cohort: Ocrelizumab + LP, RMS Cohort Arm 1: Ocrelizumab + LP, RMS Cohort Arm 2: Ocrelizumab + LP, RMS Cohort Arm 3: Ocrelizumab + LP, RMS Cohort Arm 4: Ocrelizumab + LP
AntihistamineParticipants will receive an antihistamine, such as diphenhydramine, prior to ocrelizumab infusion.	Drug	PPMS Cohort: Ocrelizumab + LP, RMS Cohort Arm 1: Ocrelizumab + LP, RMS Cohort Arm 2: Ocrelizumab + LP, RMS Cohort Arm 3: Ocrelizumab + LP, RMS Cohort Arm 4: Ocrelizumab + LP

Primary outcome

Change in Levels of NfL (Neurofilament Light) in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Time frame: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
Primary Analysis was based on following data-cut off: Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
Change in Number of CD19+ B Cells in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab
Time frame: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks
Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab
Time frame: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)
Arm 1: Baseline to post-treatment at 12 weeks Arm 2: Baseline to post-treatment at 24 weeks Arm 3: Baseline to post-treatment at 52 weeks Arm 4: Baseline to post-treatment at 12 weeks PPMS Cohort: Baseline to post-treatment at 52 weeks

Results and safety

Results posted to the registry on 4 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RMS Cohort Arm 1: Ocrelizumab + LP	23	0
RMS Cohort Arm 2: Ocrelizumab + LP	31	0
RMS Cohort Arm 3: Ocrelizumab + LP	28	0
RMS Cohort Arm 4: Ocrelizumab + LP	18	0
PPMS Cohort: Ocrelizumab + LP	31	1

Primary outcome: Change in Levels of NfL (Neurofilament Light) in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab

Time frame: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240). Mean (Standard Deviation). Unit: pg/mL

Measure	RMS Cohort Arm 1: Ocrelizumab + LP n = 21	RMS Cohort Arm 2: Ocrelizumab + LP n = 25	RMS Cohort Arm 3: Ocrelizumab + LP n = 22	RMS Cohort Arm 4: Ocrelizumab + LP n = 16	PPMS Cohort: Ocrelizumab + LP n = 28
Primary Analysis	-1232.97 (2060.37)	-1169.13 (1739.49)	-1008.13 (1132.68)	-931.83 (2816.27)	261.85 (1175.72)
LTE phase Week 144	-2331.89 (3334.80)	-644.50 (1371.39)	-1287.58 (1822.72)	-2544.33 (3807.94)	-925.32 (2507.97)
LTE phase Week 240	-2499.98 (3606.71)	-791.51 (1150.89)	-1060.33 (1678.95)	-5488.70 (4350.46)	-1221.33 (2738.19)

Population analysed: The ITT population is defined as all patients enrolled in the study who received at least one dose of Ocrevus

Primary outcome: Change in Number of CD19+ B Cells in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab

Time frame: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240). Mean (Standard Deviation). Unit: cells/μL

Measure	RMS Cohort Arm 1: Ocrelizumab + LP n = 21	RMS Cohort Arm 2: Ocrelizumab + LP n = 25	RMS Cohort Arm 3: Ocrelizumab + LP n = 22	RMS Cohort Arm 4: Ocrelizumab + LP n = 16	PPMS Cohort: Ocrelizumab + LP n = 28
Primary Analysis	-0.22 (0.26)	-0.15 (0.36)	-0.13 (0.32)	-0.18 (0.37)	-0.09 (0.11)
LTE phase Week 144	-0.11 (0.08)	-0.14 (0.20)	-0.06 (0.23)	0.15 (0.10)	-0.01 (0.09)
LTE phase Week 240	-0.08 (0.09)	-0.20 (0.26)	-0.02 (0.01)	-0.04 (0.05)	0.01 (0.03)

Population analysed: The ITT population is defined as all patients enrolled in the study who received at least one dose of Ocrevus

Primary outcome: Change From Baseline in Number of CD3+ T-Cells in CSF Post-Treatment With Ocrelizumab

Time frame: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240). Mean (Standard Deviation). Unit: cells/μL

Measure	RMS Cohort Arm 1: Ocrelizumab + LP n = 21	RMS Cohort Arm 2: Ocrelizumab + LP n = 25	RMS Cohort Arm 3: Ocrelizumab + LP n = 22	RMS Cohort Arm 4: Ocrelizumab + LP n = 16	PPMS Cohort: Ocrelizumab + LP n = 28
Primary Analysis	-6.61 (10.48)	-1.92 (3.15)	-1.46 (2.67)	-1.98 (5.10)	-3.25 (4.32)
LTE phase Week 144	-3.45 (2.33)	1.78 (9.76)	-0.83 (4.64)	2.25 (0.17)	-3.62 (5.56)
LTE phase Week 240	-3.00 (3.16)	-3.47 (2.31)	-1.41 (1.30)	-1.67 (2.42)	-1.37 (0.54)

Population analysed: The ITT population is defined as all patients enrolled in the study who received at least one dose of Ocrevus

Adverse events

Time frame: From baseline up to 5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RMS Cohort Arm 1: Ocrelizumab + LP	5 of 23 (21.7%)	23 of 23 (100%)	1 of 23
RMS Cohort Arm 2: Ocrelizumab + LP	5 of 31 (16.1%)	28 of 31 (90.3%)	0 of 31
RMS Cohort Arm 3: Ocrelizumab + LP	1 of 28 (3.6%)	27 of 28 (96.4%)	0 of 28
RMS Cohort Arm 4: Ocrelizumab + LP	5 of 18 (27.8%)	17 of 18 (94.4%)	0 of 18
PPMS Cohort: Ocrelizumab + LP	9 of 31 (29%)	31 of 31 (100%)	1 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42376811MacMillan EL, Russell-Schulz B, Alejo G, Harp C, Cameron B, Winger R, Jia S, Herman A, Kassam J, Waine M, Vavasour IM, Cross H, Tam R, Traboulsee AL, Carruthers R, Kolind SH. Longitudinal magnetic resonance spectroscopy study of metabolite changes over 2 years in relapsing and primary progressive multiple sclerosis treated with ocrelizumab. Mult Scler. 2026 Jun 30:13524585261456964. doi: 10.1177/13524585261456964. Online ahead of print.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

17 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada, Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Levels of NfL (Neurofilament Light) in CSF From Treatment Baseline to Post-Treatment With Ocrelizumab (time frame: From Baseline to post-treatment (Week 12, 24, 52 according to randomization and Weeks 144 and 240)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688985, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.