| Статус: |
Прекращено
|
| Протокол № | № 209564 |
| Тип: | ММКИ |
| Фаза: | III |
| РКИ № | 492 от 10 сентября 2020 г. |
| Начало: | 10 сентября 2020 г. |
| Окончание: | 14 января 2024 г. |
| Пациентов: | 350 |
| Наименование протокола: | Многоцентровое, долгосрочное, расширенное исследование для оценки безопасности и эффективности GSK3196165 в лечении ревматоидного артрита |
| Цель исследования: | Оценка безопасности и эффективности GSK3196165 в лечении ревматоидного артрита |
| Препарат(ы): | Отилимаб (GSK3196165) |
| Лекарственная форма: | Раствор для подкожного введения, 90 мг/мл, 150 мг/мл |
| Разработчик: | ГлаксоСмитКляйн Рисерч энд Девелопмент Лимитед |
| Страна: | Великобритания |
| CRO: | АЙКЬЮВИА РДС ГезмбХ, 125167, г. Москва, Ленинградский проспект 37А, корп.14, ~ |
| Терапевтические области: | Ревматология; |
Дополнительная информация:
ClinicalTrials.gov Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
| Статус: | Terminated |
| Фаза: | Phase 3 |
| Начало: | 12 мая 2020 г. |
| Окончание: | 24 февраля 2023 г. |
| Описание: | RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study |
| смотреть на ClinicalTrials.gov |