An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Recruiting · NCT06675955 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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. From Protocol Version 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- Study treatment is commercially marketed in the participant's country for the participant-specific disease and is reasonably accessible to the participant
- Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant
- Permanent premature discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
- Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
- Immunocompromised state
- Known active malignancy or are being actively monitored for recurrence of malignancy
- Known presence of other neurological disorders
Where it is running
44 locations listed.
- CHU Amiens Hopital Sud - Amiens Cedex1, France
- CHU de Besancon Hopital Jean Minjoz - Besançon, France
- Groupe Hospitalier Pellegrin - Bordeaux, France
- CHU Brest Hopital La Cavale Blanche - Brest, France
- Hopital neurologique Pierre Wertheimer - CHU Lyon - Bron, France
- CHU De Caen - Caen, France
- 5th Cherkasy City Center of Primary Health Care - Cherkasy, Ukraine
- Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.? - Chernihiv, Ukraine
- Bukovinsky SMU RMI Chernivtsi RCH - Chernivtsi, Ukraine
- Hopital Gabriel Montpied CHU de Clermont-Ferrand - Clermont-Ferrand, France
- SI USSRI of Medical and Social Problems of Disabilities of MOHU - Dnipro, Ukraine
- Regional Clinical Hospital - Ivano-Frankivsk, Ukraine
- St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU - Kharkiv, Ukraine
- Center of Cardiology and Neurology - Kirov, Russia
- Regional clinical hospital named after prof. S.V. Ochapovsky - Krasnodar, Russia
- Medical Center Dopomoga Plus - Kyiv, Ukraine
- Medical Center of Private Execution First Private Clinic - Kyiv, Ukraine
- CH St Vincent de Paul - Lille, France
- Volyn Regional Clinical Hospital - Lutsk, Ukraine
- Lvivska oblasna tsentralna likarnia - Lviv, Ukraine
- Hopital Gui de Chauliac - Montpellier, France
- Hopital Nord Laennec - Nantes, France
- Hôpital Pasteur - Nice, France
- FSBIH Siberian Regional Medical Centre of FMBA of Russia - Novosibirsk, Russia
- GroupeHospitalo-Universitaire Caremeau - Nîmes, France
- Perm SMA n.a. academ. E.A. Vagner - Perm, Russia
- Hopital de Hautepierre - Strasbourg, France
- NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH - Ulm, Germany
- Medical Clinical Research Center of Medical Center LLC Health Clinic - Vinnytsi, Ukraine
- Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz - Westerstede, Germany
- Deutsche Klinik für Diagnostik - Wiesbaden, Germany
- LCC "Medical center "Unimed" - Zaporizhzhya, Ukraine
- Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council - Zaporizhzhya, Ukraine
- Krasnoyarsk State Medical Academy - Krasnoyarsk, Krasnoyarsk Krai, Russia
- FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency - Krasnoyarsk, Krasnoyarsk Krai, Russia
- City Clinical Hospital #24 - Moscow, Moscow Oblast, Russia
- Federal center of brain research and neurotechnologies - Moskva, Moscow Oblast, Russia
- National Center of Social Significant Disease - Saint Petersburg, Sankt-Peterburg, Russia
- LLC Osnova - Saint Petersburg, Sankt-Peterburg, Russia
- N.P. Bechtereva Institute of the Human Brain - Saint Petersburg, Sankt-Peterburg, Russia
- City Hospital #40 of Kurortniy Administrative District - Saint Petersburg, Sankt-Peterburg, Russia
- SHI Sverdlovsk Regional Clinical Hospital #1 - Yekaterinburg, Sverdlovsk Oblast, Russia
- Vertebronevrologiya LLC - Kazan', Tatarstan Republic, Russia
- Ulyanovsk Regional Clinical Hospital - Ulyanovsk, Ulyanovsk Oblast, Russia