| Статус: |
Завершено
|
| Протокол № | №MLN0002SC-3030 |
| Тип: | ММКИ |
| Фаза: | IIIb |
| РКИ № | 313 от 10 мая 2016 г. |
| Начало: | 10 мая 2016 г. |
| Окончание: | 31 мая 2024 г. |
| Пациентов: | 80 |
| Наименование протокола: | MLN0002SC-3030 "Открытое исследование 3b фазы для определения долговременной безопасности и эффективности препарата Ведолизумаб для подкожного введения у пациентов с язвенным колитом и болезнью Крона |
| Цель исследования: | Собрать данные о долгосрочной безопасности и переносимости ведолизумаба п/к у пациентов с ЯК и БК. |
| Препарат(ы): | Ведолизумаб (MLN0002, ЭНТИВИО) |
| Лекарственная форма: | Раствор для подкожного введения 108 мг/0,68 мл |
| Разработчик: | Такеда Девелопмент Центр Юроп Лимитед |
| Страна: | Великобритания |
| CRO: | Квинтайлс ГезмбХ, 125167, г. Москва, Ленинградский проспект 37А, корп.14, Россия |
| Терапевтические области: | Гастроэнтеролог...; |
Дополнительная информация:
ClinicalTrials.gov A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
| Статус: | Completed |
| Фаза: | Phase 3 |
| Начало: | 15 апреля 2016 г. |
| Окончание: | 23 апреля 2024 г. |
| Описание: | The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis and Crohn's disease. Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC. Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study. For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens. Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study. After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems. |
| смотреть на ClinicalTrials.gov |