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A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 8, 2011
Last updated: October 25, 2016
Last verified: October 2016
This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with Rebif (interferon beta-1a) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either in Group A, ocrelizumab 600 milligram (mg) intravenously (IV) every 24 weeks plus Rabif placebo subcutaneously (SC) 3 times weekly, or, in Group B, Rebif 8.8 microgram (mcg) (Weeks 1 and 2), 22 mcg (Weeks 3 and 4), and 44 mcg (Week 5 and thereafter) SC 3 times weekly plus ocrelizumab placebo IV every 24 weeks. Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single group, active treatment open label extension, providing they fulfill the eligibility criteria.

Condition Intervention Phase
Relapsing Multiple Sclerosis
Drug: Ocrelizumab
Drug: Ocrelizumab Placebo
Drug: Rebif
Drug: Rebif placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Annualized Protocol-defined Relapse Rate at 96 Weeks [ Time Frame: 96 weeks ]

Secondary Outcome Measures:
  • Time to Onset of Confirmed Disability Progression for at least 12 weeks as Assessed by Expanded Disability Status Scale (EDSS) Score [ Time Frame: 96 weeks ]
    Confirmed disability progression is to be confirmed for at least 12 weeks after the initial event of neurological worsening occurring during the 96-week treatment period.

  • Total Number of T1 Gadolinium Enhanced Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) [ Time Frame: Weeks 24, 48, and 96 ]
  • Total Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ]
  • Percentage of Participants With Confirmed Disability Improvement for at least 12 weeks as Assessed by EDSS Score [ Time Frame: 96 weeks ]
    Confirmed disability improvement for at least 12 weeks with the initial event of neurological improvement occurring during the 96-week treatment period.

  • Time to Onset of Confirmed Disability Progression for at least 24 weeks as Assessed by EDSS Score [ Time Frame: 96 weeks ]
    Confirmed disability progression is to be confirmed for at least 24 weeks after the initial event of neurological worsening occurring during the 96-week treatment period.

  • Total Number of New T1-Hypointense Lesions as Detected by Brain MRI [ Time Frame: Weeks 24, 48, and 96 ]
  • Change From Baseline in Multiple Sclerosis Functional Composite Scale (MSFCS) Score at Week 96 [ Time Frame: Baseline, Week 96 ]
  • Percentage Change in Brain Volume as Detected by Brain MRI From Week 24 to Week 96 [ Time Frame: Week 24, Week 96 ]
  • Change From Baseline in Short Form-36 Physical Component Summary (SF-36 PCS) Score at Week 96 [ Time Frame: Baseline, Week 96 ]
  • Percentage of Participants With no Evidence of Disease Activity (NEDA) at Week 96 as Assessed by Neurological Symptoms and MRI [ Time Frame: Week 96 ]
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 96 ]
  • Exposure to Ocrelizumab (Area Under the Concentration - Time Curve) [ Time Frame: Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Week 84 and 96 visits ]
  • Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab [ Time Frame: Baseline up to Week 96 ]

Enrollment: 835
Study Start Date: September 2011
Estimated Study Completion Date: January 2020
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ocrelizumab
Ocrelizumab 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment dose and as single infusions of 600 mg on Day 1 for each 24-week treatment dose, thereafter) every 24 weeks. Placebo injections matching Rebif SC three times per week. Planned duration of double-blind treatment is 96 weeks.
Drug: Ocrelizumab
Ocrelizumab 600 mg (given as dual infusions of ocrelizumab 300 mg on Days 1 and 15 of the first 24-week treatment dose and as single infusions of 600 mg on Day 1 for each 24-week treatment dose, thereafter) every 24 weeks.
Other Name: RO4964913
Drug: Rebif placebo
Rebif dummy placebo SC according to schedule in Rebif active group.
Active Comparator: Rebif
Rebif 8.8 mcg (Weeks 1 and 2), 22 mcg (Weeks 3 and 4), 44 mcg (Week 5 and thereafter) SC injection 3 times per week. Placebo infusions matching ocrelizumab infusions every 24 weeks. Planned duration of double-blind treatment is 96 weeks.
Drug: Ocrelizumab Placebo
Ocrelizumab dummy placebo iv according to schedule in ocrelizumab active group.
Drug: Rebif
Rebif 8.8 mcg (Weeks 1 and 2), 22 mcg (Weeks 3 and 4), 44 mcg (Week 5 and thereafter) SC injection 3 times per week.
Other Name: Interferon beta-1a


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
  • At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
  • Neurologic stability for greater than or equal to (>/=) 30 days prior to both screening and baseline
  • Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive

Exclusion Criteria:

  • Primary progressive multiple sclerosis
  • Disease duration of more than 10 years in patients with EDSS score less than or equal to (</=) 2.0 at screening
  • Contraindications for MRI
  • Known presence of other neurological disorders which may mimic multiple sclerosis
  • Pregnancy or lactation
  • Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of or currently active primary or secondary immunodeficiency
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus [HIV], syphilis, tuberculosis)
  • History of progressive multifocal leukoencephalopathy
  • Contraindications to or intolerance of oral or IV corticosteroids
  • Contraindications to Rebif or incompatibility with Rebif use
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Please refer to this study by its identifier: NCT01412333

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United States, Arizona
Phoenix, Arizona, United States, 85006
Phoenix, Arizona, United States, 85050
Sun City, Arizona, United States, 85351
Tucson, Arizona, United States, 85704
United States, California
San Francisco, California, United States, 94143
Stanford, California, United States, 94305
Torrance, California, United States, 90502
United States, Colorado
Denver, Colorado, United States, 80262
Ft. Collins, Colorado, United States, 80524
United States, Connecticut
Derby, Connecticut, United States, 06418
Fairfield, Connecticut, United States, 06824
United States, Florida
Bradenton, Florida, United States, 34205
Hollywood, Florida, United States, 33021
Maitland, Florida, United States, 32751
Miami, Florida, United States, 33136
Orlando, Florida, United States, 32806
Sarasota, Florida, United States, 34292
Tampa, Florida, United States, 33613-4706
United States, Georgia
Atlanta, Georgia, United States, 30327
United States, Indiana
Ft. Wayne, Indiana, United States, 46805
Indianapolis, Indiana, United States, 46256
United States, Kansas
Kansas City, Kansas, United States, 66160
Lenexa, Kansas, United States, 66214
United States, Kentucky
Lexington, Kentucky, United States, 40513
Louisville, Kentucky, United States, 40207
United States, Massachusetts
Boston, Massachusetts, United States, 02135
Worcester, Massachusetts, United States, 01655
United States, Michigan
Ann Arbor, Michigan, United States, 48109-0666
Detroit, Michigan, United States, 48201
United States, Minnesota
Golden Valley, Minnesota, United States, 55422
United States, New Jersey
Freehold, New Jersey, United States, 07728
Newark, New Jersey, United States, 07103
Teaneck, New Jersey, United States, 07666
Toms River, New Jersey, United States, 08755
United States, New York
Latham, New York, United States, 12210
New York, New York, United States, 10065
Patchogue, New York, United States, 11772
Plainview, New York, United States, 11803
Rochester, New York, United States, 14642
Stony Brook, New York, United States, 11790
United States, North Carolina
Charlotte, North Carolina, United States, 28204
Raleigh, North Carolina, United States, 27607-6520
United States, Ohio
Akron, Ohio, United States, 44320
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Greenville, South Carolina, United States, 29607
United States, Tennessee
Cordova, Tennessee, United States, 38018
Knoxville, Tennessee, United States, 37934
Nashville, Tennessee, United States, 37205
United States, Texas
Dallas, Texas, United States, 75390
Houston, Texas, United States, 77030
Lubbock, Texas, United States, 79410
Round Rock, Texas, United States, 78681
San Antonio, Texas, United States, 78212
San Antonio, Texas, United States, 78229
United States, Washington
Seattle, Washington, United States, 98122
Buenos Aires, Argentina, C1425BWO
Ciudad Autonoma Bs As, Argentina, 1405
Ciudad de Buenos Airesa, Argentina, C1013AAB
San Juan, Argentina, 5400
Grodno, Belarus, 230017
Minsk, Belarus, 220114
Minsk, Belarus, 220116
Vitebsk, Belarus, 210032
Vitebsk, Belarus, 210037
Charleroi, Belgium, 6000
Edegem, Belgium, 2650
Kortrijk, Belgium, 8500
Bosnia and Herzegovina
Sarajevo, Bosnia and Herzegovina, 71 000
Tuzla, Bosnia and Herzegovina, 75000
Belo Horizonte, MG, Brazil, 30150-221
Juiz de Fora, MG, Brazil, 36025-330
Rio de Janeiro, RJ, Brazil, 20270-004
Campinas, SP, Brazil, 13083-888
Sao Paulo, SP, Brazil, 05403-000
Sofia, Bulgaria, 1113
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1309
Sofia, Bulgaria, 1431
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Gatineau, Quebec, Canada, J9J 0A5
Greenfield Park, Quebec, Canada, J4V 2J2
Montreal, Quebec, Canada, H3A 2B4
Montréal, Quebec, Canada, H1T 2M4
Bogota, Colombia, 000472
Pula, Croatia, 52100
Varazdin, Croatia, 42000
Zagreb, Croatia, 10000
Czech Republic
Brno, Czech Republic, 613 00
Havirov, Czech Republic, 736 00
Pardubice, Czech Republic, 532 03
Praha 4 - Krc, Czech Republic, 140 59
Teplice, Czech Republic, 415 29
Zlin, Czech Republic, 762 75
Bron, France, 69500
Creteil, France, 94010
Dijon Cedex, France, 21079
Lommé, France, 59462
Paris, France, 75651
Poissy, France, 78300
Reims, France, 51092
Rennes, France, 35033
Rouen, France, 76031
Toulouse, France, 31059
Aschaffenburg, Germany, 63739
Bamberg, Germany, 96049
Berlin, Germany, 10243
Berlin, Germany, 12163
Bonn, Germany, 53117
Düsseldorf, Germany, 40225
Essen, Germany, 45122
Essen, Germany, 45138
Frankfurt, Germany, 60528
Grevenbroich, Germany, 41515
Heidelberg, Germany, 69120
Köln, Germany, 51109
Marburg, Germany, 35043
Minden, Germany, 32429
Mittweida, Germany, 09648
Muenchen, Germany, 81377
München, Germany, 81675
Siegen, Germany, 57072
Ulm, Germany, 89073
Ulm, Germany, 89081
Dublin 4, Ireland, 4
Roma, Lazio, Italy, 00133
Roma, Lazio, Italy, 00168
Genova, Liguria, Italy, 16132
Milano, Lombardia, Italy, 20133
Montichiari, Lombardia, Italy, 25018
Torrette - Ancona, Marche, Italy, 60100
Biella, Piemonte, Italy, 13900
Orbassano, Piemonte, Italy, 10043
Acquaviva delle Fonti, Puglia, Italy, 70021
Bari, Puglia, Italy, 70124
San Giovanni Rotondo, Puglia, Italy, 71013
Cefalu, Sicilia, Italy, 90015
Aguascalientes, Mexico, 20127
Chihuahua, Mexico, 31238
Culiacan, Mexico, 80020
Culiacan, Mexico, 80270
Guadalajara, Mexico, 44620
Mexico, Mexico, 03100
Monterrey, Mexico, 64710
Tlalnepantla, Mexico, 54055
Bergen, Norway, 5021
Tønsberg, Norway, 3103
Bydgoszcz, Poland, 85-021
Jaroslaw, Poland, 37-500
Katowice, Poland, 40-595
Katowice, Poland, 40-749
Krakow, Poland, 31-505
Lodz, Poland, 90-153
Lodz, Poland, 90-324
Lublin, Poland, 20-954
Olsztyn, Poland, 10-561
Szczecin, Poland, 71-252
Warszawa, Poland, 01-697
Russian Federation
Barnaul, Russian Federation, 656024
Kazan, Russian Federation, 420101
Kirov, Russian Federation, 610014
Krasnoyarsk, Russian Federation, 660022
Nizniy Novgorod, Russian Federation, 603155
Perm, Russian Federation, 614990
Pyatigorsk, Russian Federation, 357538
Saint-Petersburg, Russian Federation, 197022
Saratov, Russian Federation, 410012
Yaroslavl, Russian Federation, 150030
Banska Bystrica, Slovakia, 974 04
Banska Bystrica, Slovakia, 975 17
Levoca, Slovakia, 054 01
Martin, Slovakia, 036 59
Nove Zamky, Slovakia, 940 34
Presov, Slovakia, 081 81
Badalona, Barcelona, Spain, 08916
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Alicante, Spain, 03010
Barcelona, Spain, 08003
Barcelona, Spain, 08035
Girona, Spain, 17007
Madrid, Spain, 28007
Madrid, Spain, 28040
Malaga, Spain, 29010
Valencia, Spain, 46010
Göteborg, Sweden, 413 45
Stockholm, Sweden, 14186
Stockholm, Sweden, 171 76
Umea, Sweden, 901 85
Ankara, Turkey, 06100
Istanbul, Turkey, 34096
Istanbul, Turkey, 34098
Istanbul, Turkey, 34394
Istanbul, Turkey, 34668
Izmir, Turkey, 35100
Izmir, Turkey, 35340
Kocaeli, Turkey, 41380
Samsun, Turkey, 55139
Trabzon, Turkey, 61080
Yenisehir-Izmir, Turkey, 35120
Chernihiv, Ukraine, 14029
Dnipropetrovsk, Ukraine, 49102
Donetsk, Ukraine, 83045
Donetsk, Ukraine, 83114
Ivano-Frankivsk, Ukraine, 76008
United Kingdom
Brighton, United Kingdom, BN2 5BE
Exeter, United Kingdom, EX2 5DW
London, United Kingdom, SE5 9NT
Plymouth, United Kingdom, PL6 8DH
Stoke on Trent, United Kingdom, ST4 6QG
Swansea, United Kingdom, SA6 6NL
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT01412333     History of Changes
Other Study ID Numbers: WA21093
2010-020315-36 ( EudraCT Number )
Study First Received: August 8, 2011
Last Updated: October 25, 2016

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic processed this record on May 25, 2017