Clinical Trial Protocol Registry

Trial information

A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis

Status:
Recruiting
Protocol number:
WA25046
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
A Phase III, multicentre, randomized, parallel-group, double-blind, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis
Brief summary:
This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in patients with primary progressive multiple sclerosis. Eligible patients will be randomized 2 : 1 to receive either ocrelizumab (300 mg intravenously, 2 infusions separated by 14 days in each treatment cycle) or placebo. The blinded treatment period will be at least 120 weeks, followed by open label treatment for patients in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Anticipated time on study treatment is up to 5.5 years. Target sample size is 630.
Study phase:
III
Study type:
Interventional; Treatment; Randomized; Parallel; Safety/efficacy study
Conditions:
  • Multiple Sclerosis, Primary Progressive
Intervention type:
Drug
Intervention name:
ocrelizumab
Primary outcome:
  1. Efficacy: Time to onset of sustained disability progression, defined as an increase in Expanded Disability Status Scale (EDSS) score that is sustained for at least 12 weeks Time frame: up to 5.5 years
Key secondary outcomes:
  1. Time to sustained disability progression, defined as an increase in EDSS score that is sustained for at least 24 weeks Time frame: up to 5.5 years
  2. Change in timed 25-foot walk Time frame: from baseline to Week 120
  3. Change in total volume of T2 lesions on magnetic resonance imaging (MRI) scans of the brain Time frame: from baseline to Week 180
  4. Safety and tolerability: Incidence of adverse events Time frame: up to 5.5 years
Inclusion criteria:
  • Adult patients, 18-55 years of age
  • Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
  • Expanded Disability Status Scale (EDSS) 3 to 6.5 points
  • Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS >/= 5.0
  • Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose
Exclusion criteria:
  • History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
  • Contraindications for Magnetic Resonance Imaging (MRI)
  • Known presence of other neurologic disorders
  • Known active infection or history of or presence of recurrent or chronic infection
  • History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
  • Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
  • Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Gender:
Males or Females
Age limits:
Min: 18 years Max: 55 years
Accepts healthy volunteers:
No
Anticipated start date:
March, 2011
Trial registration date:
28.06.2010
Date last updated:
06.05.2013
This trial is being conducted at the following locations:
Australia
  • FITZROY
  • HEIDELBERG
  • HOBART
Austria
  • INNSBRUCK
  • LINZ
  • SALZBURG
  • VILLACH
  • WIEN
Belgium
  • LA LOUVIERE
  • LEUVEN
  • SIJSELE-DAMME
Brazil
  • BELO HORIZONTE
  • GOIÂNIA
  • PORTO ALEGRE
  • RIO DE JANEIRO
Bulgaria
  • PLEVEN
  • SOFIA
Canada
  • CALGARY, AB
  • VANCOUVER, BC
  • WINNIPEG, MB
  • OTTAWA, ON
  • TORONTO, ON
  • GREENFIELD PARK, QC
  • MONTREAL, QC
Czech Republic
  • BRNO
  • PRAHA 2
  • TEPLICE
Denmark
  • SONDERBORG
Finland
  • HELSINKI
  • TAMPERE
  • TURKU
France
  • BESANCON
  • BORDEAUX
  • CAEN
  • CLERMONT-FERRAND
  • LILLE
  • LYON
  • MARSEILLE
  • MONTPELLIER
  • NANCY
  • NANTES
  • NICE
  • NIMES
  • PARIS
  • POISSY
  • REIMS
  • STRASBOURG
  • TOULOUSE
Germany
  • BAYREUTH
  • BERG
  • BERLIN
  • BOCHUM
  • DRESDEN
  • DÜSSELDORF
  • FRANKFURT
  • GIEßEN
  • HEIDELBERG
  • KÖLN
  • LEIPZIG
  • MARBURG
  • MUNICH
  • MÜNSTER
  • REGENSBURG
  • TÜBINGEN
  • ULM
  • WIESBADEN
Greece
  • ATHENS
  • THESSALONIKI
Hungary
  • BUDAPEST
  • ESZTERGOM
  • PÉCS
  • SZEGED
  • VESZPREM
Israel
  • ASHKELON
  • HAIFA
  • PETACH TIKVA
  • RAMAT-GAN
  • SAFED
  • TEL AVIV
Italy
  • CAGLIARI
  • GENOVA
  • MILANO
  • ORBASSANO
Lithuania
  • KAUNAS
  • KLAIPEDA
  • SIAULIAI
Mexico
  • AGUASCALIENTES
  • MEXICO
  • MEXICO CITY
  • MONTERREY
Netherlands
  • ROTTERDAM
  • SITTARD-GELEEN
New Zealand
  • HAMILTON
  • WELLINGTON
Norway
  • OSLO
Peru
  • BELLAVISTA
  • LIMA
  • SAN ISIDRO
Poland
  • BIALYSTOK
  • JAROSLAW
  • KATOWICE
  • KONSKIE
  • LODZ
  • LUBLIN
  • PLEWISKA
  • POZNAN
Portugal
  • ALMADA
  • AMADORA
  • COIMBRA
  • LISBOA
  • PORTO
Romania
  • BUCHAREST
  • CAMPULUNG
  • TARGU MURES
  • TIMISOARA
Russian Federation
  • KAZAN
Spain
  • ALICANTE
  • BARCELONA
  • BILBAO
  • GIRONA
  • MADRID
  • MALAGA
  • SAN SEBASTIAN
  • SANTIAGO DE COMPOSTELA
  • SEVILLA
Switzerland
  • BASEL
  • LUGANO
  • ZÜRICH
Turkey
  • ANKARA
  • EDIRNE
  • KOCAELI
U.S.A.
  • PHOENIX, AZ
  • SCOTTSDALE, AZ
  • NEWPORT BEACH, CA
  • OAKLAND, CA
  • SACRAMENTO, CA
  • SAN FRANCISCO, CA
  • AURORA, CO
  • BRADENTON, FL
  • MAITLAND, FL
  • MIAMI, FL
  • TAMPA, FL
  • VERO BEACH, FL
  • ATLANTA, GA
  • CHICAGO, IL
  • KANSAS CITY, KS
  • LENEXA, KS
  • DETROIT, MI
  • FARMINGTON HILLS, MI
  • MINNEAPOLIS, MI
  • GOLDEN VALLEY, MN
  • ST. LOUIS, MO
  • ADVANCE, NC
  • CHARLOTTE, NC
  • RALEIGH, NC
  • TEANECK, NJ
  • ALBUQUERQUE, NM
  • ALBANY, NY
  • MINEOLA, NY
  • NEW YORK, NY
  • PATCHOGUE, NY
  • ROCHESTER, NY
  • STONY BROOK, NY
  • COLUMBUS, OH
  • OKLAHOMA CITY, OK
  • TUALATIN, OR
  • PHILADELPHIA, PA
  • PROVIDENCE, RI
  • MEMPHIS, TN
  • DALLAS, TX
  • HOUSTON, TX
  • ROUND ROCK, TX
  • HENRICO, VA
  • SEATTLE, WA
  • MILWAUKEE, WI
Ukraine
  • CHERNIVTSI
  • DNIPROPETROVSK
  • KHARKIV
  • KHARKOV
  • KIEV
  • KYIV
  • LUTSK
  • LVIV
  • ODESA
  • TERNOPIL
  • VINNYTSYA
United Kingdom
  • LIVERPOOL
  • LONDON
  • NEWCASTLE UPON TYNE
  • NOTTINGHAM
Uruguay
  • INDIANAPOLIS

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