| Спонсоры |
Ведущий спонсор: Hoffmann-La Roche Коллаборационист: PPD |
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| Источник | Hoffmann-La Roche |
| Краткое содержание | This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks. |
| Подробное описание | This Phase III randomized, double-blind, double-dummy, multicenter study will evaluate the safety and efficacy of ocrelizumab administered by IV infusion every 24 weeks compared with fingolimod taken orally daily, in children and adolescents with Multiple Sclerosis aged between 10 and < 18 years. The study plans to enroll 233 patients in a 1:1 randomization (ocrelizumab:fingolimod), globally. This study consists of a double-blind, double dummy period in which patients will be treated with either active ocrelizumab or active fingolimod for at least 96 weeks. Patients who complete the double-blind period will be offered the possibility to enter an optional open-label extension treatment period of at least 144 weeks with ocrelizumab. |
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| Общий статус | Recruiting | ||||||||||||||
| Дата начала | 2022-01-31 | ||||||||||||||
| Дата завершения | 2029-11-05 | ||||||||||||||
| Дата первичного завершения | 2025-06-30 | ||||||||||||||
| Фаза | Phase 3 | ||||||||||||||
| Тип исследования | Interventional | ||||||||||||||
| Первичный результат |
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| Вторичный результат |
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| Регистрация | 233 |
| Состояние |
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| Вмешательство |
Тип вмешательства: Drug Название вмешательства: Ocrelizumab Описание: Ocrelizumab will be administered at a dose of 600 mg by IV infusion on Day 1 and Day 15 (half the dose, 2 weeks apart) and every 24 weeks thereafter. Этикетка Arm Group: Ocrelizumab Тип вмешательства: Other Название вмешательства: Ocrelizumab Placebo Описание: Ocrelizumab placebo will be administered by IV infusion on day 1 and Day 15 and every 24 weeks thereafter. Этикетка Arm Group: Fingolimod Тип вмешательства: Drug Название вмешательства: Fingolimod Описание: Fingolimod will be administered daily as 0.5 mg capsule. Этикетка Arm Group: Fingolimod Тип вмешательства: Other Название вмешательства: Fingolimod Placebo Описание: Fingolimod placebo will be administsred daily as a capsule. Этикетка Arm Group: Ocrelizumab |
| Приемлемость |
Критерии: Inclusion Criteria: - Body weight ≥ 50 kg - Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017 - EDSS at screening: 0-5.5, inclusive - Neurologic stability for ≥ 30 days prior to screening, and between screening and Day 1 - At least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 months Exclusion Criteria: - Known presence or suspicion of other neurologic disorders that may mimic MS - Significant uncontrolled somatic diseases, known active infection or any other significant condition that may preclude patient from participating in the study - Patient with severe cardiac disease or significant findings on the screening ECG Пол: All Минимальный возраст: 10 Years Максимальный возраст: 17 Years Здоровые волонтеры: No |
| Общий Официальный |
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| Общий контакт |
Фамилия: Reference Study ID Number: WN42086 https://forpatients.roche.com/ Телефон: 888-662-6728 (U.S. and Canada) | ||||||||
| Расположение |
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| Расположение Страны |
Ukraine |
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| Дата проверки |
2022-01-01 |
| Ответственная сторона |
Тип: Sponsor |
| Ключевые слова |
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| Имеет расширенный доступ | No |
| Состояние Просмотр |
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| Количество рук | 2 |
| Группа вооружений |
Метка: Ocrelizumab Тип: Experimental Описание: Participants will receive Ocrelizumab by IV infusion every 24 weeks. The first dose is given as dual infusions of half the dose of ocrelizumab on Days 1 and 15 and subsequent doses are given as single infusions of ocrelizumab every 24 weeks. Participants will also receive a placebo of fingolimod (administered as QD capsule). Метка: Fingolimod Тип: Active Comparator Описание: Participants will receive Fingolimod PO QD as per the prescribing information provided with fingolimod. Patients will also receive a placebo of ocrelizumab (administered as IV infusions on Days 1 and 15, and every 24 weeks thereafter). |
| Акроним | Operetta 2 |
| Данные пациента | Yes |
| Информация о дизайне исследования |
Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |