An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Ocrelizumab
  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.

Первичные конечные точки

• 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) [Срок оценки: Baseline up to 5 years]
• Number of Eligible Participants who Have Received Access to Ocrelizumab in the Study [Срок оценки: Up to 5 years]

Вторичные конечные точки (3)

• Number of Participants With Serious Adverse Events (SAEs) [Срок оценки: Up to 5 years]
• Number of Participants With Adverse Events (AEs) Leading to Discontinuation [Срок оценки: Up to 5 years]
• Number of Participants With Adverse Events of Special Interest (AESIs) [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 15 центров

• Krasnoyarsk State Medical Academy — Krasnoyarsk
• FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency — Krasnoyarsk
• City Clinical Hospital #24 — Moscow
• Federal center of brain research and neurotechnologies — Moskva
• National Center of Social Significant Disease — Saint Petersburg
• LLC Osnova — Saint Petersburg
• N.P. Bechtereva Institute of the Human Brain — Saint Petersburg
• City Hospital #40 of Kurortniy Administrative District — Saint Petersburg
• … и ещё 7 центров

Франция · 13 центров

• CHU Amiens Hopital Sud — Amiens Cedex1
• CHU de Besancon Hopital Jean Minjoz — Besançon
• Groupe Hospitalier Pellegrin — Bordeaux
• CHU Brest Hopital La Cavale Blanche — Brest
• Hopital neurologique Pierre Wertheimer - CHU Lyon — Bron
• CHU De Caen — Caen
• Hopital Gabriel Montpied CHU de Clermont-Ferrand — Clermont-Ferrand
• CH St Vincent de Paul — Lille
• … и ещё 5 центров

Украина · 13 центров

• 5th Cherkasy City Center of Primary Health Care — Cherkasy
• Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.? — Chernihiv
• Bukovinsky SMU RMI Chernivtsi RCH — Chernivtsi
• SI USSRI of Medical and Social Problems of Disabilities of MOHU — Dnipro
• Regional Clinical Hospital — Ivano-Frankivsk
• St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU — Kharkiv
• Medical Center Dopomoga Plus — Kyiv
• Medical Center of Private Execution First Private Clinic — Kyiv
• … и ещё 5 центров

Германия · 3 центра

• NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH — Ulm
• Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz — Westerstede
• Deutsche Klinik für Diagnostik — Wiesbaden

Идентификаторы

NCT: NCT06675955 · MN45053 · 2023-507633-21-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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