A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
- Autoimmune Disorder
- Multiple Sclerosis (MS)
Completed
- A Coruña
- Aarhus
- Ancona
- Ankara
- Augsburg
- Barcelona
- Barletta
- Basel
- Berg
- Bergamo
- Bergen
- Berlin
- Besançon
- Birmingham
- Bochum
- Bologna
- Bonn
- Bordeaux
- Breda
- Bron
- Bruxelles
- Buchholz in der Nordheide
- Böblingen
- Cagliari
- Castelló de la Plana
- Catania
- Chieti
- Clermont-Ferrand
- Coppito
- Cork
- Cádiz
- Drammen
- Dresden
- Dublin
- Dublin 4
- Düsseldorf
- Edegem
- Edinburgh
- El Palmar
- Erbach
- Exeter
- Firenze
- Frankfurt am Main
- Freiburg im Breisgau
- Gallarate
- Geleen
- Genova
- Gent
- Girona
- Glasgow
- Glostrup
- Göteborg
- Hamburg
- Hannover
- Heidelberg
- Hennigsdorf
- Hlavní město Praha
- Inverness
- İstanbul
- Itzehoe
- İzmir
- Jihlava
- Jihomoravský kraj
- Jönköping
- Kassel
- Kocaeli
- Kogarah
- L'Hospitalet de Llobregat
- La Louvière
- Lausanne
- Lazio
- Leeds
- Leipzig
- Leuven
- Lille
- Lleida
- Lombardy
- London
- Madrid
- Magdeburg
- Mainz
- Marburg
- Marseille
- Mersin
- Milano
- Montichiari
- Montpellier
- München
- Münster
- Nantes
- Naples
- Napoli
- Neuruppin
- Newcastle upon Tyne
- Nice
- Nieuwegein
- Odense
- Oldenburg in Holstein
- Oviedo
- Padova
- Palermo
- Paris
- Pavia
- Pelt
- Perugia
- Potsdam
- Pozuelo de Alarcón
- Pozzilli
- Reims
- Roma
- Rotterdam
- Salford
- Samsun
- San Giovanni Rotondo
- Sevilla
- Sheffield
- sicilia
- Siena
- Steenokkerzeel
- Stockholm
- Strasbourg
- Stuttgart
- Swansea
- Sønderborg
- Tallinn
- Tampere
- Tartu
- Tilburg
- Toulouse
- Tours
- Trabzon
- Truro
- Turku
- Tübingen
- Ulm
- València
- Verona
- Vigo
- Westerstede
NCT02861014 2015-005597-38 MA30005
Trial Summary
The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.
An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment
Eligibility Criteria
- Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
- Have a length of disease duration, from first symptom, of less than (<) 10 years
- Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
- Suboptimal disease control while on a DMT
- Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
- For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
- Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
- Inability to complete an Magnetic Resonance Imaging (MRI) procedure
- Known presence of other neurological disorders
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- History or currently active primary or secondary immunodeficiency
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- History of opportunistic infections
- History or known presence of recurrent or chronic infection
- History of malignancy
- Congestive heart failure
- Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds
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