An Open-Label, Multicenter Extension Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Ocrelizumab in Patients With Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and Without Access to a Post-Trial Access Program
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study will evaluate the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the safety and tolerability of ocrelizumab.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies \[Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), BP46016/MINTAKA, CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)\] at the time of roll-over and who do not have access to the ocrelizumab treatment locally.
• The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study.
• Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in participants of childbearing potential.
Locations
Other Locations
France
CHU Amiens Hopital Sud
RECRUITING
Amiens Cedex1
Groupe Hospitalier Pellegrin
RECRUITING
Bordeaux
Hopital neurologique Pierre Wertheimer - CHU Lyon
RECRUITING
Bron
CHU De Caen
RECRUITING
Caen
Hopital Gabriel Montpied CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
Hopital Gui de Chauliac
RECRUITING
Montpellier
Hôpital Pasteur
RECRUITING
Nice
GroupeHospitalo-Universitaire Caremeau
RECRUITING
Nîmes
Germany
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
RECRUITING
Ulm
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
RECRUITING
Westerstede
Deutsche Klinik für Diagnostik
RECRUITING
Wiesbaden
Ukraine
5th Cherkasy City Center of Primary Health Care
RECRUITING
Cherkasy
Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?
RECRUITING
Chernihiv
Bukovinsky SMU RMI Chernivtsi RCH
RECRUITING
Chernivtsi
SI USSRI of Medical and Social Problems of Disabilities of MOHU
RECRUITING
Dnipro
Regional Clinical Hospital
RECRUITING
Ivano-frankivsk
Medical Center Dopomoga Plus
RECRUITING
Kyiv
Medical Center of Private Execution First Private Clinic
RECRUITING
Kyiv
Lvivska oblasna tsentralna likarnia
RECRUITING
Lviv
LCC Medical center Unimed
RECRUITING
Zaporizhzhia
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
RECRUITING
Zaporizhzhia
Contact Information
Primary
Reference Study ID Number: MN45053 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date:2024-12-13
Estimated Completion Date:2029-12-31
Participants
Target number of participants:500
Treatments
Experimental: Ocrelizumab
Participants will receive ocrelizumab at the same dose and schedule as the parent study until access to the treatment becomes locally available, unacceptable safety concern, death or withdrawal of consent.