Select Your Region
Global
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
- Autoimmune Disorder
- Multiple Sclerosis (MS)
- Primary Progressive Multiple Sclerosis (PPMS)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- _iauliai
- Aguascalientes
- Albuquerque
- alicante--alacant-
- Almada
- Amadora
- Ashkelon
- Athina
- Aurora
- Barcelona
- Basel
- Bayreuth
- Bellavista
- Berg
- Berkeley
- Berlin
- Bilbo
- Bochum
- Bordeaux
- Brno-Bohunice
- Bron
- București
- Budapest
- Caen
- Cagliari
- Calgary
- Charlotte
- Chernivtsi
- Ciudad de México
- Clermont-Ferrand
- Coimbra
- Columbus
- Câmpulung
- Dallas
- Damme
- Detroit
- Dnipro
- Donostia
- Dresden
- Düsseldorf
- East Providence
- Esztergom
- Farmington
- Fitzroy
- Frankfurt am Main
- Geleen
- Genova
- Gießen
- Girona
- Goiás
- Hamilton
- Heidelberg
- Helsinki
- Hlavní město Praha
- Hobart
- Houston
- Indianapolis
- Innsbruck
- Jerusalem
- Kansas City
- Katowice
- Kaunas
- Kazan
- Kharkiv
- Klaipėda
- ko_skie
- Kyiv
- Köln
- L'viv
- La Louvière
- Leipzig
- Lille
- Lima
- Linz
- Lisboa
- Liverpool
- Lombardia
- London
- Longueuil
- Lublin
- Lugano
- Luts'k
- Madrid
- Marseille
- Memphis
- Miami
- Minas Gerais
- Mineola
- Minneapolis
- Monterrey
- Montpellier
- Montréal
- Málaga
- München
- Münster
- Nancy
- New York
- Newcastle upon Tyne
- Newport Beach
- Nice
- Nottingham
- Nîmes
- Odesa
- Oklahoma City
- Oslo
- Ottawa
- Paris
- Patchogue
- Petah Tikva
- Philadelphia
- Phoenix
- Poissy
- Porto
- Pécs
- Raleigh
- Ramat Gan
- Regensburg
- Reims
- Richmond
- Rio de Janeiro
- Rio Grande do Sul
- Rotterdam
- Sacramento
- Saint-Herblain
- Salzburg
- San Francisco
- San Isidro
- Sanatorio San Luigi
- Santiago de Compostela
- Scottsdale
- Seattle
- Sevilla
- Sofia
- St. Louis
- Strasbourg
- Szeged
- Tampere
- Teaneck
- Tel Aviv-Yafo
- teplice-1
- Timișoara
- Toronto
- Toulouse
- Tsfat
- Turku
- Târgu Mureș
- Tübingen
- Ulm
- Vancouver
- Vero Beach
- Veszprém
- Vinnytsia
- Wellington
- Wien
- Wiesbaden
- Winnipeg
- Łódź
- Πειραιας
Trial Identifier:
NCT01194570 2010-020338-25 WA25046
Trial Summary
This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01194570, WA25046, 2010-020338-25
Trial Identifier
Ocrelizumab, Placebo
Treatments
Multiple Sclerosis, Primary Progressive
Condition
Official 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
Eligibility Criteria
All
Gender
≥18 Years & ≤ 55 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria)
- EDSS at screening from 3 to 6.5 points
- Disease duration from onset of MS symptoms less than (<) 15 years if EDSS greater than (>) 5.0; <10 years if EDSS greater than or equal to (>/=) 5.0
- Sexually active male and female participants 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 MS, secondary progressive, or progressive relapsing MS at screening
- Inability to complete an MRI (contraindications for 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-cluster of differentiation 4 (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
For the latest version of this information please go to www.forpatients.roche.com