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Global
This is an Extension Study of the Roche P-trial to Investigate Safety and Effectiveness of a Single Ocrelizumab Dose in Participants With Multiple Sclerosis (MS)
- Autoimmune Disorder
- Multiple Sclerosis (MS)
Please note that the recruitment status of the trial at your site may differ.
Trial Status:
Recruiting
This trial runs in
Cities
- 's-Hertogenbosch
- A Coruña
- Aalborg
- Aarhus
- aci-castello
- Amsterdam
- Ankara
- Bergamo
- Besançon
- Bologna
- Bordeaux
- Braga
- Bratislava Region
- Bratislavský kraj
- Brugge
- Budapest
- Buenos Aires
- Bydgoszcz
- Cagliari
- Caserta
- Castelló de la Plana
- Catania
- Cefalù
- Chieti
- Chihuahua
- Ciudad de México
- claviers
- Clermont-Ferrand
- Coimbra
- Coppito
- Culiacán Rosales
- Dublin 4
- Edegem
- El Palmar
- Esztergom
- Firenze
- Gallarate
- Gdańsk
- Geleen
- Genova
- Glasgow
- Glostrup
- Gonesse
- Gothenburg
- Gouda
- Hatay
- Hlavní město Praha
- İstanbul
- Karlstad
- Katowice
- Kraków
- L'Hospitalet de Llobregat
- La Louvière
- La Tronche
- Lazio
- Ljubljana
- Lleida
- Lombardia
- Lombardy
- London
- Loures
- Lublin
- luik
- Madrid
- Maribor
- Milano
- molise
- Montichiari
- Montréal
- Nancy
- Naples
- Napoli
- Newcastle upon Tyne
- Nice
- Nîmes
- Ottawa
- Padova
- Palermo
- Paraná
- Pavia
- Pelt
- Perugia
- Poissy
- Porto
- Porto Alegre
- Pozzilli
- Rio Grande do Sul
- Roma
- Rome
- Rosario
- Rouen
- Saint-Herblain
- Salford
- Samsun
- San Giovanni Rotondo
- Sevilla
- sicilia
- Siena
- Sofia
- South Carolina
- Stavanger
- Stockholm
- Swansea
- São Paulo
- Toronto
- Torrette
- Toulon
- Trabzon
- Trnavský kraj
- València
- Vancouver
- Verona
- Vigo
- Warszawa
- Zagreb
- Łódź
Trial Identifier:
NCT03599245 2017-004886-29 MN39158
Trial Summary
This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT03599245,MN39158,2017-004886-29
Trial Identifier
Ocrelizumab
Treatments
Multiple Sclerosis
Condition
Official Title
A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials
Eligibility Criteria
All
Gender
≥18 Years & ≤ 65 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Signed Informed Consent Form
- Able to comply with the study protocol, in the investigator's judgment
- Completed the treatment period of Roche sponsored ocrelizumab P-trials
Exclusion Criteria
- Hypersensitivity to ocrelizumab or to any of its excipients.
- Participantss in a severely immunocompromised state until the condition resolves.
- Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation.
- Existence of a contra-indication as per SmPC
- Prohibited concomitant medication as specified in protocol
- Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study
For the latest version of this information please go to www.forpatients.roche.com