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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 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 C1204AAD, Argentina

Captial Federal 1181, Argentina

Ciudad Autonoma Bs As C1209AAB, Argentina

Rosario 2000, Argentina

Linz 4021, Austria

Salzburg 5020, Austria

St. P├Âlten 3100, Austria

Wien 1090, Austria

Brugge 8000, Belgium

Bruxelles 1200, Belgium

Roeselare B-8800, Belgium

Pleven 5800, Bulgaria

Sofia 1113, Bulgaria

Sofia 1142, Bulgaria

Sofia 1407, Bulgaria

Sofia 1606, Bulgaria

Valparaiso 2340000, Chile

Brno 656 91, Czech Republic

Hradec Kralove 500 05, Czech Republic

Jihlava 58633, Czech Republic

Pardubice 532 03, Czech Republic

Prague 12808, Czech Republic

Teplice 415 29, Czech Republic

Tallinn 10138, Estonia

Tallinn 10617, Estonia

Tartu 51014, Estonia

Helsinki 00290, Finland

Tampere 33520, Finland

Bordeaux 33076, France

Clermont Ferrand 63003, France

Nancy 54035, France

Nimes 30900, France

Strasbourg 67098, France

Bayreuth 95445, Germany

Berlin 10365, Germany

Berlin 12157, Germany

Berlin 12163, Germany

Berlin 12351, Germany

Berlin 13088, Germany

Berlin 13347, Germany

Dresden 01307, Germany

Hamburg 22291, Germany

Hannover 30559, Germany

Mainz 55131, Germany

M├╝nster 48149, Germany

Neuburg 86633, Germany

Oldenburg 26122, Germany

Prien 83209, Germany

Regensburg 93053, Germany

Rostock 18147, Germany

T├╝bingen 72076, Germany

Westerstede 26655, Germany

Budapest 1076, Hungary

Budapest 1036, Hungary

Budapest 1033, Hungary

Budapest 1086, Hungary

Budapest 1145, Hungary

Budapest 1204, Hungary

Esztergom 2500, Hungary

Gyor 9024, Hungary

Haifa 31048, Israel

Haifa 34362, Israel

Ramat-Gan 52621, Israel

Zefat 13100, Israel

Riga 1015, Latvia

Riga LV-1002, Latvia

Kaunas 50009, Lithuania

Klaipeda 92288, Lithuania

Vilnius 08661, Lithuania

Mexico 03600, Mexico

Monterrey 64460, Mexico

Monterrey 64000, Mexico

Nieuwegein 3430 EM, Netherlands

Sittard-Geleen 6162 BG, Netherlands

Hamilton 3240, New Zealand

Callao 04, Peru

Lima 18, Peru

Lima, Peru

Pueblo Libre Lima 21, Peru

Gdansk 80-803, Poland

Katowice 40-588, Poland

Katowice 40-595, Poland

Plewiska 62-064, Poland

Almada 2801-951, Portugal

Amadora 2720-276, Portugal

Braga 4710-243, Portugal

Coimbra 3041-801, Portugal

Lisboa 1649-035, Portugal

Ekaterinburg 620102, Russian Federation

Kemerovo 650066, Russian Federation

Moscow 115682, Russian Federation

Mosow 129128, Russian Federation

Novosibirsk 630007, Russian Federation

Novosibirsk 630090, Russian Federation

Samara 443099, Russian Federation

Smolensk 214018, Russian Federation

St. Petersburg 194354, Russian Federation

St. Petersburg 194044, Russian Federation

Tyumen 625000, Russian Federation

Belgrade 11040, Serbia

Kragujevac 34000, Serbia

NIS 18000, Serbia

Bratislava 851 07, Slovakia

Bratislava 826 06, Slovakia

Bratislava 813 69, Slovakia

Nitra 949 11, Slovakia

Zilina 010 01, Slovakia

Zilina 012 07, Slovakia

Durban 4319, South Africa

Johannesburg 2010, South Africa

Madrid 28222, Spain

Sevilla 41009, Spain

Basel 4031, Switzerland

Bern 3010, Switzerland

Lugano 6900, Switzerland

Mannouba 2010, Tunisia

Monastir 5000, Tunisia

Sfax 3029, Tunisia

Tunis 1006, Tunisia

Tunis 1008, Tunisia

Donetsk 83099, Ukraine

Kharkov 61068, Ukraine

Kyiv 03110, Ukraine

Lviv 79010, Ukraine

Vinnytsya 21005, Ukraine

Liverpool L9 7LJ, United Kingdom

London E1 1BD, United Kingdom

Birmingham, Alabama 35233, United States

Phoenix, Arizona 85004, United States

La Jolla, California 92037, United States

Los Angeles, California 90027, United States

Newport Beach, California 92663, United States

Pasadena, California 91105, United States

Sacramento, California 95816, United States

Sacramento, California 95817, United States

San Francisco, California 94143, United States

Maitland, Florida 32751, United States

Melbourne, Florida 32901, United States

Pembroke Pines, Florida 33026, United States

South Miami, Florida 33143, United States

Tampa, Florida 33609, United States

Tampa, Florida 33613-4706, United States

Goiania, GO 74140-040, Brazil

Atlanta, Georgia 30309, United States

Atlanta, Georgia 30322, United States

Atlanta, Georgia 30342, United States

Chicago, Illinois 60611, United States

Evanston, Illinois 60201, United States

Northbrook, Illinois 60062, United States

Avon, Indiana 46123, United States

Des Moines, Iowa 50314, United States

Roma, Lazio 00189, Italy

Gallarate, Lombardia 21013, Italy

Milano, Lombardia 20132, Italy

Scarbrough, Maine 04074, United States

Baltimore, Maryland 21201, United States

Boston, Massachusetts 02114, United States

Clinton TWP, Michigan 48035, United States

Farmington Hills, Michigan 48334, United States

Golden Valley, Minnesota 55422, United States

Jackson, Mississippi 39216, United States

Chesterfield, Missouri 63017, United States

St. Louis, Missouri 63110, United States

St. Louis, Missouri 63131, United States

Omaha, Nebraska 68198-3255, United States

Albuquerque, New Mexico 87131, United States

St. Leonards, New South Wales 2065, Australia

Albany, New York 12208, United States

Amherst, New York 14226, United States

Buffalo, New York 14203, United States

Cedarhurst, New York 11516, United States

Advance, North Carolina 27006, United States

Chapel Hill, North Carolina 27599, United States

Charlotte, North Carolina 28203, United States

Charlotte, North Carolina 28207, United States

Cincinnati, Ohio 45219, United States

Columbus, Ohio 43212, United States

Oklahoma City, Oklahoma 73104, United States

Portland, Oregon 97225, United States

Tualatin, Oregon 97062, United States

Philadelphia, Pennsylvania 19141, United States

Pittsburgh, Pennsylvania 15232, United States

Porto Alegre, RS 90110-270, Brazil

East Providence, Rhode Island 02915, United States

Joinville, SC 89201-165, Brazil

Santa Cruz De Tenerife, Tenerife 38010, Spain

Houston, Texas 77030, United States

Lubbock, Texas 79410, United States

Padova, Veneto 35128, Italy

Burlington, Vermont 05401, United States

Bilbao, Vizcaya 48013, Spain

Tacoma, Washington 98405, United States

Additional Information

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

Page last updated: August 23, 2015

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