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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507633-21-01 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab | Experimental | Participants will receive ocrelizumab at the currently approved dose of 600 mg, IV infusion or 920 mg, SC injection as per the schedule in the parent study until access to the treatment becomes locally available, unacceptable safety concern, death or withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | Ocrelizumab will be administered at the approved dose of 600 mg, IV infusion or 920 mg, SC injection, according to the regimen in the parent study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a) | PROMISnq PFMS-15a includes 15 items that evaluate the impact of MS on a participant's physical functioning, including mobility, upper limb function and activities of daily living. Nine items assess the degree of difficulty in completing physical activities using a 5-point verbal rating scale ranging from 5="without any difficulty" to 1="unable to do". Four items assess physical function limitations, rated from 5="not at all" to 1="cannot do". Two items assess the amount of difficulty associated with selected physical activities, rated from 5="no difficulty" to 1="can't do". Scores are reported as a standardized T-score metric, with higher scores reflecting better physical functioning. | Baseline up to 5 years |
| Number of Eligible Participants who Have Received Access to Ocrelizumab in the Study | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | Up to 5 years | |
| Number of Participants With Adverse Events (AEs) Leading to Discontinuation | Up to 5 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: MN45053 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. Only) | global-roche-genentech-trials@gene.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens Hopital Sud | Recruiting | Amiens Cedex1 | 80054 | France | ||
| CHU de Besancon Hopital Jean Minjoz |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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|
| Number of Participants With Adverse Events of Special Interest (AESIs) |
| Up to 5 years |
| Recruiting |
| Besançon |
| 25030 |
| France |
| Groupe Hospitalier Pellegrin | Recruiting | Bordeaux | 33076 | France |
| CHU Brest Hopital La Cavale Blanche | Recruiting | Brest | 29609 | France |
| Hopital neurologique Pierre Wertheimer - CHU Lyon | Recruiting | Bron | 69677 | France |
| CHU De Caen | Recruiting | Caen | 14033 | France |
| Hopital Gabriel Montpied CHU de Clermont-Ferrand | Withdrawn | Clermont-Ferrand | 63003 | France |
| CH St Vincent de Paul | Recruiting | Lille | 59000 | France |
| Hopital Gui de Chauliac | Recruiting | Montpellier | 34295 | France |
| Hopital Nord Laennec | Recruiting | Nantes | 44093 | France |
| Hôpital Pasteur | Recruiting | Nice | 06002 | France |
| GroupeHospitalo-Universitaire Caremeau | Recruiting | Nîmes | 30029 | France |
| Hopital de Hautepierre | Recruiting | Strasbourg | 67098 | France |
| NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH | Recruiting | Ulm | 89073 | Germany |
| Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz | Recruiting | Westerstede | 26655 | Germany |
| Deutsche Klinik für Diagnostik | Recruiting | Wiesbaden | 65191 | Germany |
| Krasnoyarsk State Medical Academy | Recruiting | Krasnoyarsk | Krasnoyarsk Krai | 660022 | Russia |
| FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency | Recruiting | Krasnoyarsk | Krasnoyarsk Krai | 660037 | Russia |
| City Clinical Hospital #24 | Recruiting | Moscow | Moscow Oblast | 127015 | Russia |
| Federal center of brain research and neurotechnologies | Recruiting | Moskva | Moscow Oblast | 117997 | Russia |
| National Center of Social Significant Disease | Recruiting | Saint Petersburg | Sankt-Peterburg | 197110 | Russia |
| LLC Osnova | Recruiting | Saint Petersburg | Sankt-Peterburg | 197341 | Russia |
| N.P. Bechtereva Institute of the Human Brain | Recruiting | Saint Petersburg | Sankt-Peterburg | 197376 | Russia |
| City Hospital #40 of Kurortniy Administrative District | Recruiting | Saint Petersburg | Sankt-Peterburg | 197706 | Russia |
| SHI Sverdlovsk Regional Clinical Hospital #1 | Recruiting | Yekaterinburg | Sverdlovsk Oblast | 620102 | Russia |
| Vertebronevrologiya LLC | Recruiting | Kazan' | Tatarstan Republic | 420043 | Russia |
| Ulyanovsk Regional Clinical Hospital | Recruiting | Ulyanovsk | Ulyanovsk Oblast | 432063 | Russia |
| Center of Cardiology and Neurology | Recruiting | Kirov | 610007 | Russia |
| Regional clinical hospital named after prof. S.V. Ochapovsky | Recruiting | Krasnodar | 350086 | Russia |
| FSBIH Siberian Regional Medical Centre of FMBA of Russia | Recruiting | Novosibirsk | 630007 | Russia |
| Perm SMA n.a. academ. E.A. Vagner | Recruiting | Perm | 614990 | Russia |
| 5th Cherkasy City Center of Primary Health Care | Recruiting | Cherkasy | 18029 | Ukraine |
| Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.? | Recruiting | Chernihiv | 14029 | Ukraine |
| Bukovinsky SMU RMI Chernivtsi RCH | Recruiting | Chernivtsi | 58002 | Ukraine |
| SI USSRI of Medical and Social Problems of Disabilities of MOHU | Recruiting | Dnipro | 49027 | Ukraine |
| Regional Clinical Hospital | Recruiting | Ivano-Frankivsk | 76008 | Ukraine |
| St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU | Recruiting | Kharkiv | 61068 | Ukraine |
| Medical Center Dopomoga Plus | Recruiting | Kyiv | 02123 | Ukraine |
| Medical Center of Private Execution First Private Clinic | Recruiting | Kyiv | 03037 | Ukraine |
| Volyn Regional Clinical Hospital | Recruiting | Lutsk | 43005 | Ukraine |
| Lvivska oblasna tsentralna likarnia | Recruiting | Lviv | 79010 | Ukraine |
| Medical Clinical Research Center of Medical Center LLC Health Clinic | Recruiting | Vinnytsi | 21009 | Ukraine |
| LCC "Medical center "Unimed" | Recruiting | Zaporizhzhia | 69035 | Ukraine |
| Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council | Recruiting | Zaporizhzhia | 69600 | Ukraine |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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