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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Rebif (Drug); Rebif placebo (Drug); ocrelizumab (Drug); ocrelizumab placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

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 weeks plus Rebif placebo subcutaneously (sc) three times weekly, or, in group B, Rebif 8. 8 mcg (Weeks 1+2)/22 mcg (Weeks 3+4)/44 mcg (Week 5 and following) sc three times weekly plus ocrelizumab placebo iv every 24 weeks. Anticipated time on study treatment is 96 weeks.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Annualized protocol-defined relapse rate by 2 years in patients with relapsing MS

Secondary outcome:

Time to onset of sustained disability progression for at least 12 weeks

Time to onset of sustained disability progression for at least 24 weeks

Proportion of relapse-free patients

Change in total T2 lesion volume as detected by brain MRI

Total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI

Change in Multiple Sclerosis Functional Composite Scale (MSFCS) score

Change in brain volume as detected by brain MRI

Safety: Incidence of adverse events

Pharmacokinetics: Exposure to ocrelizumab (area under the concentration - time curve)

Immunogenicity: Human anti-human antibodies (HAHA) levels

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

- 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

Locations and Contacts

Buenos Aires C1425BWO, Argentina

Ciudad Autonoma Bs As 1405, Argentina

Ciudad de Buenos Airesa C1013AAB, Argentina

San Juan 5400, Argentina

Grodno 230017, Belarus

Minsk 220114, Belarus

Minsk 220116, Belarus

Vitebsk 210032, Belarus

Vitebsk 210037, Belarus

Charleroi 6000, Belgium

Edegem 2650, Belgium

Kortrijk 8500, Belgium

Sarajevo 71 000, Bosnia and Herzegovina

Tuzla 75000, Bosnia and Herzegovina

Sofia 1113, Bulgaria

Sofia 1233, Bulgaria

Sofia 1309, Bulgaria

Sofia 1431, Bulgaria

Bogota 000472, Colombia

Pula 52100, Croatia

Varazdin 42000, Croatia

Zagreb 10000, Croatia

Brno 613 00, Czech Republic

Havirov 736 00, Czech Republic

Pardubice 532 03, Czech Republic

Praha 4 - Krc 140 59, Czech Republic

Teplice 415 29, Czech Republic

Zlin 762 75, Czech Republic

Bron 69500, France

Creteil 94010, France

Dijon Cedex 21079, France

Lommé 59462, France

Paris 75651, France

Poissy 78300, France

Reims 51092, France

Rennes 35033, France

Rouen 76031, France

Toulouse 31059, France

Aschaffenburg 63739, Germany

Bamberg 96049, Germany

Berlin 10243, Germany

Berlin 12163, Germany

Bonn 53117, Germany

Düsseldorf 40225, Germany

Essen 45122, Germany

Essen 45138, Germany

Frankfurt 60528, Germany

Grevenbroich 41515, Germany

Heidelberg 69120, Germany

Köln 51109, Germany

Marburg 35043, Germany

Minden 32429, Germany

Mittweida 09648, Germany

Muenchen 81377, Germany

München 81675, Germany

Siegen 57072, Germany

Ulm 89078, Germany

Ulm 89081, Germany

Dublin 4, Ireland

Aguascalientes 20127, Mexico

Chihuahua 31238, Mexico

Culiacan 80020, Mexico

Culiacan 80270, Mexico

Guadalajara 44620, Mexico

Mexico 03100, Mexico

Monterrey 64710, Mexico

Tlalnepantla 54055, Mexico

Bergen 5021, Norway

Tønsberg 3103, Norway

Bydgoszcz 85-021, Poland

Jaroslaw 37-500, Poland

Katowice 40-595, Poland

Katowice 40-749, Poland

Krakow 31-505, Poland

Lodz 90-153, Poland

Lodz 93-121, Poland

Lublin 20-954, Poland

Olsztyn 10-561, Poland

Szczecin 71-252, Poland

Warszawa 01-697, Poland

Barnaul 656024, Russian Federation

Kazan 420101, Russian Federation

Kirov 610014, Russian Federation

Krasnoyarsk 660022, Russian Federation

Nizniy Novgorod 603155, Russian Federation

Perm 614990, Russian Federation

Pyatigorsk 357538, Russian Federation

Saint-Petersburg 197022, Russian Federation

Saratov 410012, Russian Federation

Yaroslavl 150030, Russian Federation

Banska Bystrica 974 04, Slovakia

Banska Bystrica 975 17, Slovakia

Levoca 054 01, Slovakia

Martin 036 59, Slovakia

Nove Zamky 940 34, Slovakia

Presov 081 81, Slovakia

Alicante 03010, Spain

Barcelona 08003, Spain

Barcelona 08035, Spain

Girona 17007, Spain

Madrid 28007, Spain

Madrid 28040, Spain

Malaga 29010, Spain

Valencia 46010, Spain

Göteborg 413 45, Sweden

Stockholm 14186, Sweden

Stockholm 171 76, Sweden

Umeå 901 85, Sweden

Ankara 06100, Turkey

Istanbul 34394, Turkey

Istanbul 34098, Turkey

Istanbul 34668, Turkey

Istanbul 34096, Turkey

Izmir 35100, Turkey

Izmir 35340, Turkey

Kocaeli 41380, Turkey

Samsun 55139, Turkey

Trabzon 61080, Turkey

Yenisehir-Izmir 35120, Turkey

Chernihiv 14029, Ukraine

Dnipropetrovsk 49102, Ukraine

Donetsk 83045, Ukraine

Donetsk 83114, Ukraine

Ivano-Frankivsk 76008, Ukraine

Brighton BN2 5BE, United Kingdom

Exeter EX2 5DW, United Kingdom

London SE5 9NT, United Kingdom

Plymouth PL6 8DH, United Kingdom

Stoke on Trent ST4 6QG, United Kingdom

Swansea SA6 6NL, United Kingdom

Truro TR1 3LJ, United Kingdom

Calgary, Alberta T2N 2T9, Canada

Edmonton, Alberta T6G 2C8, Canada

Phoenix, Arizona 85006, United States

Phoenix, Arizona 85050, United States

Sun City, Arizona 85351, United States

Tucson, Arizona 85704, United States

Badalona, Barcelona 08916, Spain

L'Hospitalet de Llobregat, Barcelona 08907, Spain

Vancouver, British Columbia V6T 2B5, Canada

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Stanford, California 94305, United States

Torrance, California 90502, United States

Denver, Colorado 80262, United States

Ft. Collins, Colorado 80524, United States

Derby, Connecticut 06418, United States

Fairfield, Connecticut 06824, United States

Bradenton, Florida 34205, United States

Hollywood, Florida 33021, United States

Maitland, Florida 32751, United States

Miami, Florida 33136, United States

Orlando, Florida 32806, United States

Sarasota, Florida 34292, United States

Tampa, Florida 33613-4706, United States

Atlanta, Georgia 30327, United States

Ft. Wayne, Indiana 46805, United States

Indianapolis, Indiana 46256, United States

Kansas City, Kansas 66160, United States

Lenexa, Kansas 66214, United States

Lexington, Kentucky 40513, United States

Louisville, Kentucky 40207, United States

Roma, Lazio 00133, Italy

Roma, Lazio 00168, Italy

Genova, Liguria 16132, Italy

Milano, Lombardia 20133, Italy

Montichiari, Lombardia 25018, Italy

Belo Horizonte, MG 30150-221, Brazil

Juiz de Fora, MG 36025-330, Brazil

Torrette - Ancona, Marche 60100, Italy

Boston, Massachusetts 02135, United States

Worcester, Massachusetts 01655, United States

Ann Arbor, Michigan 48109-0666, United States

Detroit, Michigan 48201, United States

Golden Valley, Minnesota 55422, United States

Freehold, New Jersey 07728, United States

Newark, New Jersey 07103, United States

Teaneck, New Jersey 07666, United States

Toms River, New Jersey 08755, United States

Latham, New York 12210, United States

New York, New York 10065, United States

Patchogue, New York 11772, United States

Plainview, New York 11803, United States

Rochester, New York 14642, United States

Stony Brook, New York 11790, United States

Charlotte, North Carolina 28204, United States

Raleigh, North Carolina 27607-6520, United States

Akron, Ohio 44320, United States

Ottawa, Ontario K1H 8L6, Canada

Toronto, Ontario M5B 1W8, Canada

Philadelphia, Pennsylvania 19104, United States

Willow Grove, Pennsylvania 19090, United States

Biella, Piemonte 13900, Italy

Orbassano, Piemonte 10043, Italy

Acquaviva delle Fonti, Puglia 70021, Italy

Bari, Puglia 70124, Italy

San Giovanni Rotondo, Puglia 71013, Italy

Gatineau, Quebec J9J 0A5, Canada

Greenfield Park, Quebec J4V 2J2, Canada

Montreal, Quebec H3A 2B4, Canada

Montréal, Quebec H1T 2M4, Canada

Rio de Janeiro, RJ 20270-004, Brazil

Campinas, SP 13083-888, Brazil

Sao Paulo, SP 05403-000, Brazil

Cefalu, Sicilia 90015, Italy

Greenville, South Carolina 29607, United States

Knoxville, Tennessee 37934, United States

Memphis, Tennessee 38120, United States

Nashville, Tennessee 37205, United States

Dallas, Texas 75390, United States

Houston, Texas 77030, United States

Lubbock, Texas 79410, United States

Round Rock, Texas 78681, United States

San Antonio, Texas 78212, United States

San Antonio, Texas 78229, United States

Seattle, Washington 98122, United States

Additional Information

Starting date: September 2011
Last updated: August 17, 2015

Page last updated: August 23, 2015

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