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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01412333
First received: August 8, 2011
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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 patients with relapsing multiple sclerosis. Patients will be randomized to receive either in group A, ocrelizumab 600 mg intravenously (iv) every 24 wee ks plus Rebif placebo subcutaneously (sc) three times weekly, or, in group B, R ebif 8.8 mcg (Weeks 1+2)/22 mcg (Weeks 3+4)/44 mcg (Week 5 and following) sc thr ee times weekly plus ocrelizumab placebo iv every 24 weeks. Anticipated time on study treatment is 96 weeks.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: Rebif
Drug: Rebif placebo
Drug: ocrelizumab
Drug: ocrelizumab placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 by 2 years in patients with relapsing MS [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to onset of sustained disability progression for at least 12 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Time to onset of sustained disability progression for at least 24 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Proportion of relapse-free patients [ Time Frame: Week 96 ] [ Designated as safety issue: No ]
  • Change in total T2 lesion volume as detected by brain MRI [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
  • Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Change in Multiple Sclerosis Functional Composite Scale (MSFCS) score [ Time Frame: from baseline to Week 96 ] [ Designated as safety issue: No ]
  • Change in brain volume as detected by brain MRI [ Time Frame: from Week 24 to Week 96 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Exposure to ocrelizumab (area under the concentration - time curve) [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity: Human anti-human antibodies (HAHA) levels [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Enrollment: 835
Study Start Date: September 2011
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Rebif placebo
Rebif dummy placebo sc according to schedule in Rebif active group B
Drug: ocrelizumab
600 mg iv every 24 weeks (dual infusions of 300 mg on Day 1 and 15 of Cycle 1, single infusion of 600 mg on Day 1 of each following cycle), 96 weeks
Active Comparator: B Drug: Rebif
8.8 mcg (Weeks 1+2) / 22 mcg (Weeks 3+4) / 44mcg (Week 5 and following) subcutaneously 3 times weekly, 96 weeks
Other Name: Rebif
Drug: ocrelizumab placebo
Ocrelizumab dummy placebo iv according to schedule in ocrelizumab active group A

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, 18-55 years of age inclusive
  • 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 >/= 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 </= 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 (e.g. hepatitis B or C, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412333

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85050
Phoenix, Arizona, United States, 85006
Sun City, Arizona, United States, 85351
Tucson, Arizona, United States, 85741
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
Knoxville, Tennessee, United States, 37934
Memphis, Tennessee, United States, 38120
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, 78229
San Antonio, Texas, United States, 78212
United States, Washington
Seattle, Washington, United States, 98122
Argentina
Buenos Aires, Argentina, C1425BWO
Ciudad Autonoma Bs As, Argentina, 1405
Ciudad de Buenos Airesa, Argentina, C1013AAB
San Juan, Argentina, 5400
Belarus
Grodno, Belarus, 230017
Minsk, Belarus, 220114
Minsk, Belarus, 220116
Vitebsk, Belarus, 210032
Vitebsk, Belarus, 210037
Belgium
Charleroi, Belgium, 6000
Edegem, Belgium, 2650
Kortrijk, Belgium, 8500
Bosnia and Herzegovina
Sarajevo, Bosnia and Herzegovina, 71 000
Tuzla, Bosnia and Herzegovina, 75000
Brazil
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
Bulgaria
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1309
Sofia, Bulgaria, 1113
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
Colombia
Bogota, Colombia, 000472
Croatia
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
France
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
Germany
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, 89078
Ulm, Germany, 89081
Ireland
Dublin, Ireland, 4
Italy
Roma, Lazio, Italy, 00168
Roma, Lazio, Italy, 00133
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
Mexico
Aguascalientes, Mexico, 20127
Chihuahua, Mexico, 31238
Culiacan, Mexico, 80270
Culiacan, Mexico, 80020
Guadalajara, Mexico, 44620
Mexico, Mexico, 03100
Monterrey, Mexico, 64710
Tlalnepantla, Mexico, 54055
Norway
Bergen, Norway, 5021
Tønsberg, Norway, 3103
Poland
Bydgoszcz, Poland, 85-021
Jaroslaw, Poland, 37-500
Katowice, Poland, 40-684
Katowice, Poland, 40-595
Krakow, Poland, 31-505
Lodz, Poland, 90-153
Lodz, Poland, 93-121
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
Slovakia
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
Spain
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, 28040
Madrid, Spain, 28007
Malaga, Spain, 29010
Valencia, Spain, 46010
Sweden
Göteborg, Sweden, 413 45
Stockholm, Sweden, 171 76
Stockholm, Sweden, 14186
Umeå, Sweden, 901 85
Turkey
Ankara, Turkey, 06100
Istanbul, Turkey, 34096
Istanbul, Turkey, 34394
Istanbul, Turkey, 34098
Istanbul, Turkey, 34668
Izmir, Turkey, 35340
Izmir, Turkey, 35100
Kocaeli, Turkey, 41380
Samsun, Turkey, 55139
Trabzon, Turkey, 61080
Yenisehir-Izmir, Turkey, 35120
Ukraine
Chernihiv, Ukraine, 14029
Dnipropetrovsk, Ukraine, 49102
Donetsk, Ukraine, 83114
Donetsk, Ukraine, 83045
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 8BX
Stoke on Trent, United Kingdom, ST4 6QG
Swansea, United Kingdom, SA6 6NL
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01412333     History of Changes
Other Study ID Numbers: WA21093
Study First Received: August 8, 2011
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Interferon beta 1a
Interferon-beta
Adjuvants, Immunologic
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014