A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Phase 3 – large-scale trial before approval
Conditions:
Multiple Sclerosis
Sponsor: Hoffmann-La Roche
trial.available_in:
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Overview
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.
Who can participate
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
Locations
32
Argentina (1)
Hospital Español
Ciudad Autonoma Bs As
Australia (1)
Royal North Shore Hospital
St Leonards , New South Wales
Belarus (1)
Grodno University Hospital
Grodno , Brest Oblast
Brazil (1)
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goinia , Goiás
Bulgaria (1)
MHAT Avis Medica OOD Department of Neurology
Pleven
Canada (1)
Calgary MS Clinic
Calgary , Alberta
Croatia (1)
General Hospital Varazdin
Varaždin
Czech Republic (1)
Fakultni nemocnice Brno
Brno
Estonia (1)
West Tallinn Central Hospital
Tallinn
Finland (1)
Tammer Tutka Oy
Tampere
France (1)
CHU CAEN - Hôpital de la Côte de Nacre
Caen , Calvados
Germany (1)
Universitaetsklinikum Tuebingen
Tübingen , Baden-Wurttemberg
Hungary (1)
S-Medicon Egeszsegugyi Szolgaltato Kft.
Budapest
Israel (1)
Hadassah University Hospital - Ein Kerem
Jerusalem
Italy (1)
Azienda Socio Sanitaria Territoriale della Valle Olona (pres
Gallarate , Aosta Valley
Latvia (1)
Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology
Riga
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
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