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 (34) 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
CHU de Besancon Hopital Jean Minjoz
RECRUITING
Besançon
Groupe Hospitalier Pellegrin
RECRUITING
Bordeaux
CHU Brest Hopital La Cavale Blanche
RECRUITING
Brest
Hopital neurologique Pierre Wertheimer - CHU Lyon
RECRUITING
Bron
CHU De Caen
RECRUITING
Caen
Hopital Gabriel Montpied CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
CH St Vincent de Paul
RECRUITING
Lille
Hopital Gui de Chauliac
RECRUITING
Montpellier
Hôpital Pasteur
RECRUITING
Nice
GroupeHospitalo-Universitaire Caremeau
RECRUITING
Nîmes
Hopital de Hautepierre
RECRUITING
Strasbourg
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
Russian Federation
Vertebronevrologiya LLC
RECRUITING
Kazan'
Center of Cardiology and Neurology
RECRUITING
Kirov
Regional clinical hospital named after prof. S.V. Ochapovsky
RECRUITING
Krasnodar
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
RECRUITING
Krasnoyarsk
City Clinical Hospital #24
RECRUITING
Moscow
FSBIH Siberian Regional Medical Centre of FMBA of Russia
RECRUITING
Novosibirsk
City Hospital #40 of Kurortniy Administrative District
RECRUITING
Saint Petersburg
Ulyanovsk Regional Clinical Hospital
RECRUITING
Ulyanovsk
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
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU
RECRUITING
Kharkiv
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.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov