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CompletedNCT00676715Updated Dec 31, 2024Results posted

A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

A Phase 2 interventional study of Placebo and Ocrelizumab in Multiple Sclerosis, Relapsing-Remitting, sponsored by Genentech, Inc.. Completed at 84 sites in 18 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex (interferon beta-1a) controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS).

02

Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting
03

In context

Multiple Sclerosis, Relapsing-Remitting

615 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.

This study's enrollment of 220 is above the median of 72 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 517 studies on the registry; 22 are open to participants now.

Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.

First submitted after Genentech, Inc. became part of Hoffmann-La Roche.

Browse Genentech, Inc. studies →All Hoffmann-La Roche studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
  • Relapsing-remitting multiple sclerosis (MS)
  • Ages 18-55 years inclusive
  • For sexually active female and male participants of reproductive potential, use of reliable means of contraception

Exclusion criteria

Exclusion Criteria:

  • Secondary or primary progressive multiple sclerosis at screening
  • Incompatibility with MRI
  • Contra-indications to or intolerance of oral or IV corticosteroids
  • Known presence of other neurologic disorders
  • Pregnancy or lactation
  • Lack of peripheral venous access
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal
  • Congestive heart failure
  • Known active bacterial, viral, fungal, mycobacterial infection or other infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
  • History or known presence of recurrent or chronic infection
  • 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)
  • History of alcohol or drug abuse within 24 weeks prior to randomization
  • History of or currently active primary or secondary immunodeficiency
  • History of coagulation disorders
  • Treatment with any investigational agent within 4 weeks of screening
  • Receipt of a live vaccine within 6 weeks prior to randomization
  • Incompatibility with Avonex use
  • Previous treatment with rituximab
  • Previous treatment with lymphocyte-depleting therapies except mitoxantrone
  • Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization
  • Treatment with beta interferons, glatiramer acetate, IV immunoglobulin, plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization
  • Systemic corticosteroid therapy within 4 weeks prior to randomization
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
220 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Participants received two intravenous (IV) infusions of matching placebo separated by 14 days in Cycle 1, followed by two infusions of ocrelizumab 300 mg separated by 14 days in cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4. Each cycle was of 168 days.

    Drug: Placebo

  • Experimental
    Ocrelizumab 600 mg

    Participants two IV infusions of ocrelizumab 300 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 600 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.

    Drug: Ocrelizumab

  • Experimental
    Ocrelizumab 1000 mg

    Participants received two IV infusions of ocrelizumab 1000 mg separated by 14 days in Cycle 1, followed by an infusion of ocrelizumab 1000 mg on Day 1 and an infusion of placebo on Day 15 of Cycle 2. A single infusion of ocrelizumab 1000 mg was administered on Day 1 of Cycle 3 and a single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycle 4. Each cycle was of 168 days.

    Drug: Ocrelizumab

  • Active comparator
    Avonex

    Participants received weekly intramuscular injections of Avonex 30 microgram (mcg) in Cycle 1, followed by two infusions of OCR 300 mg separated by 14 days in Cycle 2. A single infusion of ocrelizumab 600 mg was administered on Day 1 of Cycles 3 and 4. Each cycle was of 168 days.

    Drug: Avonex

Interventions

  • DrugPlacebo

    Placebo matching to ocrelizumab administered as IV infision in Cycle 1 Day 1.

  • DrugOcrelizumab

    Ocrelizumab 300 mg was administered in cycle 1 followed by an infusion of ocrelizumab 600 mg on Day 1. A single infusion of ocrelizumab 600 mg was administered on Day 1 of cycles 3 and 4.

    Also known as: RO4964913

  • DrugAvonex

    Avonex was administered weekly intramuscular injections of 30 mcg in cycle 1 Day 1.

    Also known as: Interferon-beta-alpha1

06

What researchers measure

Primary outcomes

  1. Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain

    Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.

    Time frame: Week 12 to Week 24

Secondary outcomes

  1. Annualized Protocol Defined Relapse Rate at Week 24

    Adjusted annualized relapse rate for geographical region is reported here. The relapse rate was calculated as the total number of relapses for each participant divided by the total number of patient-years.

    Time frame: Week 24

  2. Percentage of Participants Who Remained Relapse Free at Week 24

    Percentage of participants who remained relapse free at week 24 were reported. Percentages have been rounded off to the first decimal.

    Time frame: Week 24

  3. Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24

    Change from baseline in total volume of T2 lesions on MRI scans of the brain at Week 24 was reported.

    Time frame: Baseline, Week 24

  4. Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain

    Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.

    Time frame: Weeks 4 to Week 24

  5. Total Number of Gadolinium-Enhancing T1 Lesions

    Total number of gadolinium-enhancing T1 lesions from Week 4 to Week 24 were reported.

    Time frame: Weeks 4 to Week 24

07

Results

Posted May 11, 2017

Participant flow

A total of 220 participants were randomized, of which 218 received study treatment. Participants took part in the study at 79 investigative sites across 18 countries from July 17, 2008, to November 08, 2023.

Treatment Period (TP)
Participant flow — Treatment Period (TP)
MilestonePlacebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mg
Started54555554
Completed48464346
Not completed69128
Withdrew: Adverse event0322
Withdrew: Death0010
Withdrew: Failure to return1000
Withdrew: Violation of selection criteria at entry0010
Withdrew: Refused treatment/did not cooperate1231
Withdrew: Withdrew consent3333
Withdrew: Insufficient therapeutic response1121
Withdrew: Administrative0001
Treatment-free Period (TFP)
Participant flow — Treatment-free Period (TFP)
MilestonePlacebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mg
Started49485049
Completed35323035
Not completed14162014
Withdrew: Withdrawal by subject3345
Withdrew: Reason not provided81087
Withdrew: Lost to follow-up2262
Withdrew: Adverse event0010
Withdrew: Death1110
Open Label Extension (OLE)
Participant flow — Open Label Extension (OLE)
MilestonePlacebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mg
Started29321924
Completed22211114
Not completed711810
Withdrew: Reason not provided3414
Withdrew: Lost to follow-up0011
Withdrew: Withdrawal by subject2433
Withdrew: Adverse event0310
Withdrew: Death2022

Outcome measures

PrimaryTotal Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain

Mean of total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 12, 16, 20, 24 was determined using average imputation method.

Time frame:
Week 12 to Week 24
Reported as:
Mean · lesions
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain
lesionsPlacebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mg
Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain5.6 ± 12.530.6 ± 1.520.2 ± 0.656.9 ± 16.01
Statistical analysis
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 600 mg / Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = <0.0001
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 1000 mg/ Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = <0.0001
  • Placebo / Ocrelizumab 600 mg vs Avonex / Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = 0.7496
SecondaryAnnualized Protocol Defined Relapse Rate at Week 24

Adjusted annualized relapse rate for geographical region is reported here. The relapse rate was calculated as the total number of relapses for each participant divided by the total number of patient-years.

Time frame:
Week 24
Reported as:
Number · relapses per year
Annualized Protocol Defined Relapse Rate at Week 24
relapses per yearPlacebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mg
Annualized Protocol Defined Relapse Rate at Week 240.557 (0.370 to 0.839)0.127 (0.054 to 0.299)0.213 (0.110 to 0.414)0.364 (0.220 to 0.602)
Statistical analysis
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 600 mg / Ocrelizumab 600 mg · Poisson model · p = 0.0019
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 1000 mg/ Ocrelizumab 600 mg · Poisson model · p = 0.0136
  • Placebo / Ocrelizumab 600 mg vs Avonex / Ocrelizumab 600 mg · Poisson model · p = 0.1814
SecondaryPercentage of Participants Who Remained Relapse Free at Week 24

Percentage of participants who remained relapse free at week 24 were reported. Percentages have been rounded off to the first decimal.

Time frame:
Week 24
Reported as:
Number · percentage of participants
Percentage of Participants Who Remained Relapse Free at Week 24
percentage of participantsPlacebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mg
Percentage of Participants Who Remained Relapse Free at Week 2475.9 (64.5 to 87.3)85.5 (76.1 to 94.8)87.3 (78.5 to 96.1)77.8 (66.7 to 88.9)
Statistical analysis
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 600 mg / Ocrelizumab 600 mg · Cochran-Mantel-Haenszel chi-square test · p = 0.1978 · Relative risk (rr): 0.60 · 95% CI 0.27 to 1.34Cochran-Mantel-Haenszel (CMH) chi-square test stratified by geographical region only.
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 1000 mg/ Ocrelizumab 600 mg · CMH chi-square test · p = 0.1310 · Relative risk (rr): 0.53 · 95% CI 0.23 to 1.22CMH chi-square test stratified by geographical region only.
  • Placebo / Ocrelizumab 600 mg vs Avonex / Ocrelizumab 600 mg · CMH chi-square tes · p = 0.8206 · Relative risk (rr): 0.92 · 95% CI 0.46 to 1.84CMH chi-square test stratified by geographical region only.
SecondaryChange From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24

Change from baseline in total volume of T2 lesions on MRI scans of the brain at Week 24 was reported.

Time frame:
Baseline, Week 24
Reported as:
Mean · cubic millimeter (mm^3)
Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24
cubic millimeter (mm^3)Placebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mg
Baseline8950.84 ± 9776.26113972.61 ± 19930.15813178.30 ± 14271.38313209.11 ± 17206.511
Change at Week 24-112.31 ± 1464.206-878.84 ± 2756.839-600.89 ± 2105.9641040.06 ± 4510.140
Statistical analysis
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 600 mg / Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = 0.1391Van Elteren test is stratified by region only.
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 1000 mg/ Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = 0.1596Van Elteren test is stratified by region only.
  • Placebo / Ocrelizumab 600 mg vs Avonex / Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = 0.4740Van Elteren test is stratified by region only.
SecondaryTotal Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain

Total number of new gadolinium-enhancing T1 lesions observed by MRI scans of the brain were reported.

Time frame:
Weeks 4 to Week 24
Reported as:
Mean · lesions
Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain
lesionsPlacebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mg
Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain5.1 ± 11.990.8 ± 1.950.8 ± 2.166.2 ± 13.79
Statistical analysis
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 600 mg / Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = <0.0001Van Elteren test is stratified by region only.
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 1000 mg/ Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = <0.0001Van Elteren test is stratified by region only.
  • Placebo / Ocrelizumab 600 mg vs Avonex / Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = 0.4985Van Elteren test is stratified by region only.
SecondaryTotal Number of Gadolinium-Enhancing T1 Lesions

Total number of gadolinium-enhancing T1 lesions from Week 4 to Week 24 were reported.

Time frame:
Weeks 4 to Week 24
Reported as:
Mean · lesions
Total Number of Gadolinium-Enhancing T1 Lesions
lesionsPlacebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mg
Total Number of Gadolinium-Enhancing T1 Lesions8.7 ± 17.542.5 ± 5.101.8 ± 5.2610.3 ± 22.15
Statistical analysis
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 600 mg / Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = 0.0004Van Elteren test is stratified by region only.
  • Placebo / Ocrelizumab 600 mg vs Ocrelizumab 1000 mg/ Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = <0.0001Van Elteren test is stratified by region only.
  • Placebo / Ocrelizumab 600 mg vs Avonex / Ocrelizumab 600 mg · Van Elteren Test (stratified) · p = 0.2725Van Elteren test is stratified by region only.

Adverse events

Collected over Up to 787 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo/Ocrelizumab 600mg3/54 (5.6%)11/54 (20.4%)52/54 (96.3%)
Ocrelizumab 600mg/Ocrelizumab 600mg1/55 (1.8%)17/55 (30.9%)47/55 (85.5%)
Ocrelizumab 1000mg/Ocrelizumab 600mg3/55 (5.5%)16/55 (29.1%)45/55 (81.8%)
Avonex/Ocrelizumab 600 mg2/54 (3.7%)16/54 (29.6%)45/54 (83.3%)
Ocrelizumab 600 mg Open Label Extension (OLE)6/103 (5.8%)28/103 (27.2%)85/103 (82.5%)
Most frequent serious events
Showing 10 of 73
Most frequent serious events
EventPlacebo/Ocrelizumab 600mgOcrelizumab 600mg/Ocrelizumab 600mgOcrelizumab 1000mg/Ocrelizumab 600mgAvonex/Ocrelizumab 600 mgOcrelizumab 600 mg Open Label Extension (OLE)
COVID-19 PNEUMONIAInfections and infestations3/543/550/550/546/103
URINARY TRACT INFECTIONInfections and infestations0/540/553/550/543/103
COVID-19Infections and infestations1/541/550/552/544/103
PNEUMONIAInfections and infestations2/541/551/550/544/103
MULTIPLE SCLEROSIS RELAPSENervous system disorders0/540/550/552/540/103
SEPSISInfections and infestations1/540/551/550/542/103
BACK PAINMusculoskeletal and connective tissue disorders1/541/551/550/542/103
MULTIPLE SCLEROSIS PSEUDO RELAPSENervous system disorders0/540/551/551/542/103
ACUTE RESPIRATORY FAILURERespiratory, thoracic and mediastinal disorders1/540/550/551/542/103
CARDIAC ARRESTCardiac disorders0/540/550/551/541/103
Most frequent other events
Showing 10 of 68
Most frequent other events
EventPlacebo/Ocrelizumab 600mgOcrelizumab 600mg/Ocrelizumab 600mgOcrelizumab 1000mg/Ocrelizumab 600mgAvonex/Ocrelizumab 600 mgOcrelizumab 600 mg Open Label Extension (OLE)
INFUSION RELATED REACTIONInjury, poisoning and procedural complications29/5425/5529/5520/5423/103
MULTIPLE SCLEROSIS RELAPSENervous system disorders26/5419/5521/5529/5428/103
HEADACHENervous system disorders15/549/5510/5512/547/103
NASOPHARYNGITISInfections and infestations10/5415/5512/559/5420/103
URINARY TRACT INFECTIONInfections and infestations14/5410/5515/5510/5423/103
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations10/5414/5511/557/5415/103
COVID-19Infections and infestations12/547/555/552/5426/103
INFLUENZA LIKE ILLNESSGeneral disorders1/542/552/5511/543/103
FATIGUEGeneral disorders5/547/5511/554/548/103
BACK PAINMusculoskeletal and connective tissue disorders9/545/554/557/546/103

Baseline characteristics

The safety population included all participants who received any study drug and underwent at least one assessment of safety.

Age, Continuous
Age, Continuous(years)Placebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mgTotal
Mean38.0 ± 8.835.6 ± 8.538.5 ± 8.738.1 ± 9.337.6 ± 8.8
Sex: Female, Male
Sex: Female, Male(Participants)Placebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mgTotal
Female36353832141
Male1820172277
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mgTotal
Hispanic or Latino667726
Not Hispanic or Latino48494847192
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo / Ocrelizumab 600 mgOcrelizumab 600 mg / Ocrelizumab 600 mgOcrelizumab 1000 mg/ Ocrelizumab 600 mgAvonex / Ocrelizumab 600 mgTotal
American Indian or Alaska Native01001
Asian10001
Native Hawaiian or Other Pacific Islander00000
Black or African American03216
White52515353209
More than one race00000
Unknown or Not Reported10001
08

Study locations

84 sites
  • Phoenix Neurological Associates Ltd
    Phoenix, Arizona 85006, United States
  • Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
  • East Bay Physicians Med Group;Sutter East Bay Med Foundation
    Berkeley, California 94705, United States
  • University of California San Francisco
    San Francisco, California 94117, United States
  • Advanced Neurology of Colorado, LLC
    Fort Collins, Colorado 80528, United States
  • Bradenton Research Center
    Bradenton, Florida 34205, United States
  • MS Center of Vero Beach
    Vero Beach, Florida 32960, United States
  • Shepherd Center; Multiple Sclerosis Center
    Atlanta, Georgia 30309, United States
  • University of Chicago; Neurology
    Chicago, Illinois 60637, United States
  • Kansas University Medical Center
    Kansas City, Kansas 66103, United States
  • John Hopkins University
    Baltimore, Maryland 21205, United States
  • Michigan Institute for Neurological Disorders
    Farmington Hills, Michigan 48334, United States
  • Dartmouth-Hitchcock Medical Center; Dept of Neurology
    Lebanon, New Hampshire 03756, United States
  • Columbia University Medical Center; The Neurological Institute of New York
    New York, New York 10032, United States
  • Island Neurological Associates, P.C.
    Plainview, New York 11803, United States
  • Suny At Stony Brook; Department Of Neurology
    Stony Brook, New York 11794, United States
  • The Neurological Institute PA
    Charlotte, North Carolina 28204, United States
  • Clinical Research of Winston Salem
    Winston-Salem, North Carolina 27103, United States
  • Cleveland Clinic
    Cleveland, Ohio 44106, United States
  • Ohio State University Med Ctr; MS Center
    Columbus, Ohio 43221, United States
  • Legacy Health System; Clinical Research & Tech Ctr
    Tualatin, Oregon 97062, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37212, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
  • Integra Clinical Research, Llc
    San Antonio, Texas 78229, United States
  • Fletcher Allen Health Care/University of Vermont
    Burlington, Vermont 5405, United States
  • University of Virginia - Fontain Research Park
    Charlottesville, Virginia 22903, United States
  • UZ Antwerpen
    Edegem, 2650, Belgium
  • First MHAT; Clinic of Neurology
    Sofia, 1000, Bulgaria
  • Shat of Cardiovascular Diseases; Clinic of Neurology
    Sofia, 1309, Bulgaria
  • ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
    Sofia, 1407, Bulgaria
  • UMHAT Tzaritza Yoanna Sofia; CLINIC OF NEUROLOGY
    Sofia, 1527, Bulgaria
  • CCB Medical institute, Ministry of Interior Sofia; CLINIC OF NEUROLOGY
    Sofia, 1606, Bulgaria
  • Military Medical Academy; Neurology
    Sofia, 1606, Bulgaria
  • Uni of British Columbia Hospital; Ms Clinical Research Group
    Vancouver, British Columbia V6T 2B5, Canada
  • St. Michael'S Hospital
    Toronto, Ontario M5B 1W8, Canada
  • McGill University; Montreal Neurological Institute; Neurological and Psychiatric
    Montreal, Quebec H3A 2B4, Canada
  • Fakultni Nemocnice Ostrava; Klinika hematoonkologie FNO a LF OU
    Ostrava, 708 52, Czechia
  • Krajska Nemocnice Pardubice Neurologicka Klinika
    Pardubice, 532 03, Czechia
  • Fakultni nemocnice Motol; Neurologicka klinika
    Prague, 150 06, Czechia
  • Nemocnice Teplice; Neurologicke Oddeleni - Ms Centrum
    Teplice, 415 29, Czechia
  • Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
    Aarhus N, 8200, Denmark
  • Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
    Bordeaux, 33076, France
  • CHU De Caen; Service De Neurologie Dejerine
    Caen, 14033, France
  • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
    Clermont-Ferrand, 63003, France
  • CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge
    Nîmes, 30029, France
  • St. Joseph-Krankenhaus
    Berlin, 13088, Germany
  • Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
    Berlin, 13347, Germany
  • Asklepios Klinik Nord-Heidberg; Neurologie
    Hamburg, 22417, Germany
  • Universitatsklinikum Marburg; Zentrum für Nervenheilkunde, Klinik für Psychiatrie+Psychotherapie
    Marburg, 35039, Germany
  • Ospedale S.Andrea-Universita di Roma; Centro Sclerosi Multipla
    Rome, Lazio 00189, Italy
  • Hospital CIMA, Sta. Engracia
    Monterrey, Nuevo León 64060, Mexico
  • Instituto Biomedico De Investigacion A.C.
    Aguascalientes, 20127, Mexico
  • Unidad de Investigacion CIMA SC
    Chihuahua City, 31200, Mexico
  • Hospital Cima Chihauhau
    Chihuahua City, 31328, Mexico
  • Spitalul Clinic Colentina; Clinica de Neurologie
    Bucharest, 020125, Romania
  • Spitalul Clinic Judetean de Urgenta Targu Mures; Clinica Neurologie
    Târgu Mureş, 540136, Romania
  • Central Clinical Hospital #2 N.A. Semashko OAO RJHD
    Moskva, Moscow Oblast 107150, Russia
  • Municipal City Hospital #33; Neurology
    Nizhny Novgorod, Niznij Novgorod 603076, Russia
  • SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
    Yekaterinburg, Sverdlovsk Oblast 620102, Russia
  • LLC Research Medical Complex Vashe Zdorovie
    Kazan', Tatarstan Republic 4420029, Russia
  • Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
    Tyumen, Tyumen Oblast 625048, Russia
  • MRC for Oncology and Neurology; Neurology
    Novosibirsk, 630090, Russia
  • Clinical Center of Serbia; Institute of Neurology
    Belgrade, 11000, Serbia
  • Clinical Center Nis; Clinic for Mental Health
    Niš, 18000, Serbia
  • Clinic of Neurology
    Nova Sad, 21000, Serbia
  • Fakultna Nemocnica F. D. Roosevelta; Ii. Neurologicka Klinika Szu
    Banská Bystrica, 975 17, Slovakia
  • Fakultna Nemocnica, Pracovisko Stare Mesto; Neurology
    Bratislava, 813 69, Slovakia
  • Fakultna Nemocnica Paterua, Pracovisko Trieda Snp1 Kosice; Neurologicka Klinika
    Košice, 041 66, Slovakia
  • Fakultna Nemocnica Nitra; Neurologicka Klinika
    Nitra, 949 01, Slovakia
  • Nemocnica s Poliklinikou Spisska Nova Ves, a.s.
    Spišská Nová Ves, 05201, Slovakia
  • Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
    Barcelona, 08035, Spain
  • Hospital Clinic i Provincial; Servicio de Neurologia
    Barcelona, 08036, Spain
  • Hospital Ramon y Cajal; Servicio de Neurologia
    Madrid, 28034, Spain
  • Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
    Málaga, 29010, Spain
  • Hospital Universitario Virgen Macarena; Servicio de Neurologia
    Seville, 41009, Spain
  • Hospital Universitario La Fe; Unidad de Esclerosis Multiple
    Valencia, 46026, Spain
  • Universitätsspital Basel; Neurologie
    Basel, 4031, Switzerland
  • Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology
    Kharkiv, 61068, Ukraine
  • City Clin.Hosp #4; Dept. of Neurology
    Kyiv, 03110, Ukraine
  • Ukr.State Inst. of Med and Social Probl. Disab; Dept of Neur and Border states
    Propetrovsk, 49027, Ukraine
  • Vin.Reg.Psych.Hosp.N.A Yuschenko O.I., Vnmu N.A. Pyrogov; Department of Nervous Diseases
    Vinnytsia, 21005, Ukraine
  • Walton Centre NHS Foundation Trust, Neuroscience Research Centre; CLINICAL TRIALS UNIT
    Liverpool, L9 7LJ, United Kingdom
  • Uni Hospital Queens Medical Centre; Neurology
    Nottingham, NG7 2UH, United Kingdom
  • Royal Hallamshire Hospital; Neurology
    Sheffield, S10 2JF, United Kingdom
09

References and documents

Publications

  • Kappos L, Li D, Calabresi PA, O'Connor P, Bar-Or A, Barkhof F, Yin M, Leppert D, Glanzman R, Tinbergen J, Hauser SL. Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet. 2011 Nov 19;378(9805):1779-87. doi: 10.1016/S0140-6736(11)61649-8. Epub 2011 Oct 31. PubMed 22047971 ↗
10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2008 to primary completion in Mar 2012, 43 months.

Results were first posted in May 2017, 5 years 2 months after primary completion. A results delay was requested in Mar 2013.

Of 23 phase 2 interventional studies under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 68. This study's 43 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2008
First posted
May 13, 2008
StartActual
Jul 17, 2008
Primary completionActual
Mar 9, 2012
CompletionActual
Nov 8, 2023
Results delay requested
Mar 25, 2013
Results first posted
May 11, 2017
Last update
Dec 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00676715
Lead sponsor
Genentech, Inc.
Collaborators
Roche Pharma AG
Responsible party
Sponsor
First posted
May 13, 2008
Start date
Jul 17, 2008
Primary completion
Mar 9, 2012
Completion
Nov 8, 2023
Results posted
May 11, 2017
Last update
Dec 31, 2024

Study contacts

Clinical Trials
study director · Genentech, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ocrelizumab

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