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A rollover study to evaluate the long-term safety and efficacy of ocrelizumab in patients with multiple sclerosis
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
- Autoimmune Disorder
- Multiple Sclerosis (MS)
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:
Active, not recruiting
This trial runs in
Cities
- Abington
- Aguascalientes
- Albuquerque
- Almada
- ambert
- Atlanta
- Aurora
- Banskobystrický kraj
- Barcelona
- Barnaul
- Basel
- Bayreuth
- Bergen
- Berlin
- Bilbo
- Bonn
- Bordeaux
- Boston
- Braga
- Bratislavský kraj
- Brescia
- Brno
- Brno-Bohunice
- Bron
- Brugge
- Bruxelles
- București
- Budapest
- Buenos Aires
- Burlington
- bzl
- Caen
- Calgary
- Charlotte
- Chernihiv
- Chicago
- Chihuahua
- Cincinnati
- Ciudad de México
- Coimbra
- Columbus
- Conflans-Sainte-Honorine
- Culiacán Rosales
- Câmpulung
- Detroit
- Dnipro
- Dresden
- Düsseldorf
- Edegem
- Edmonton
- eeklo
- Essen
- Exeter
- Farmington
- Fitzroy
- Frankfurt
- Gallarate
- Gatineau
- Gdańsk
- Geleen
- Genova
- Gießen
- Guadalajara
- Göteborg
- Hamilton
- Havířov
- Hickory
- Hlavní město Praha
- Houston
- Hrodna
- Indianapolis
- Innsbruck
- İstanbul
- Ivano-Frankivs'k
- Jerusalem
- jihlava-1
- Kansas City
- Katowice
- Kaunas
- Kazan
- Kemerovo
- Kharkiv
- Kirov
- Klaipėda
- Knoxville
- Kragujevac
- Kraków
- Královéhradecký kraj
- Kyiv
- L'Hospitalet de Llobregat
- Laguna Hills
- Leipzig
- Lille
- Linz
- Lisbon
- Liverpool
- Lombardia
- London
- Longueuil
- Lubbock
- Lublin
- Lugano
- Lviv
- Madrid
- Majadahonda
- Manouba
- Memphis
- Miami
- Milano
- Minneapolis
- Minsk
- Mittweida
- Monastir
- Monterrey
- Montréal
- Moscow
- Moskva
- Málaga
- München
- Münster
- Nancy
- Newark
- Newcastle upon Tyne
- Nice
- Nizhny Novgorod
- Niš
- Northbrook
- Nottingham
- Novosibirsk
- Odesa
- Oklahoma City
- Olsztyn
- Omaha
- Orlando
- Ottawa
- Palo Alto
- Pardubice
- Patchogue
- Pennsylvania
- Perm
- Petah Tikva
- Phoenix
- Pleven
- Plewiska
- Ponderano
- Portland
- Providence
- Pyatigorsk
- Pécs
- Raleigh
- Ramat Gan
- Regensburg
- Rio de Janeiro
- Rio Grande do Sul
- Roeselare
- Roma
- Round Rock
- Rīga
- Saint Petersburg
- Saint-Herblain
- Salt
- Samara
- Samsun
- San Antonio
- San Francisco
- Sanatorio San Luigi
- Sankt-Peterburg
- Santa Catarina
- Santiago de Compostela
- Saransk
- Seattle
- Sevilla
- sicilia
- Siemianowice Śląskie
- Smolensk
- Sofia
- St Leonards
- St. Louis
- State of Mexico
- State of São Paulo
- Stavropol
- Stockholm
- Stockholms län
- Stony Brook
- Strasbourg
- Swansea
- Tacoma
- Tallinn
- Tampa
- Tampere
- Tartu
- Teaneck
- Tel Aviv-Yafo
- teplice-1
- therapeutica
- Toronto
- Torrette
- Trabzon
- tyumen
- Tübingen
- Ulm
- Vancouver
- vara_din
- Vero Beach
- Vilnius
- Vinnytsia
- Vitebsk
- Warszawa
- Westerstede
- Wien
- windsor
- Yekaterinburg
- Zagreb
- Łódź
- Žilinský kraj
Trial Identifier:
NCT05269004 2023-505974-14-00 MN43964
Trial Summary
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT05269004, MN43964, 2023-505974-14-00
Trial Identifier
Ocrelizumab
Treatments
Multiple Sclerosis
Condition
Official Title
A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet
Exclusion Criteria
- Concurrent participation in any clinical trial (other than the Parent study)
- Unable or unwilling to comply with the requirements of the protocol
For the latest version of this information please go to www.forpatients.roche.com