- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01892436
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (FUTURE 1 ext)
A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Queensland
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Maroochydore, Queensland, Австралия, 4558
- Novartis Investigative Site
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Victoria
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Malvern East, Victoria, Австралия, 3145
- Novartis Investigative Site
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Buenos Aires, Аргентина, C1417EYG
- Novartis Investigative Site
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Caba, Аргентина, C1419AHN
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Cordoba, Аргентина, X5016KEH
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Córdoba, Аргентина, X5000EDC
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Buenos Aires
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Caba, Buenos Aires, Аргентина, C1181ACH
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Santa Fe
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Rosario, Santa Fe, Аргентина, S2000CFJ
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Genk, Бельгия, 3600
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Gent, Бельгия, 9000
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Leuven, Бельгия, 3000
- Novartis Investigative Site
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Pleven, Болгария, 5800
- Novartis Investigative Site
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Sofia, Болгария, 1612
- Novartis Investigative Site
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Gabrovo
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Sevlievo, Gabrovo, Болгария, 5400
- Novartis Investigative Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Бразилия, 90610-000
- Novartis Investigative Site
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SP
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Sao Paulo, SP, Бразилия, 04023-900
- Novartis Investigative Site
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Sao Paulo, SP, Бразилия, 04266 010
- Novartis Investigative Site
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Aachen, Германия, 52064
- Novartis Investigative Site
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Erlangen, Германия, 91054
- Novartis Investigative Site
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Erlangen, Германия, 91056
- Novartis Investigative Site
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Gommern, Германия, 39245
- Novartis Investigative Site
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Hamburg, Германия, 22415
- Novartis Investigative Site
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Hildesheim, Германия, 31134
- Novartis Investigative Site
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Koeln, Германия, 50937
- Novartis Investigative Site
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Leipzig, Германия, 04103
- Novartis Investigative Site
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Nürnberg, Германия, 90429
- Novartis Investigative Site
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Ratingen, Германия, 40878
- Novartis Investigative Site
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Zerbst, Германия, 39261
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Ashkelon, Израиль, 78278
- Novartis Investigative Site
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Haifa, Израиль, 3339419
- Novartis Investigative Site
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Ramat Gan, Израиль, 5265601
- Novartis Investigative Site
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Tel Aviv, Израиль, 6423906
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CT
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Catania, CT, Италия, 95100
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PO
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Prato, PO, Италия, 59100
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SI
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Siena, SI, Италия, 53100
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VR
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Verona, VR, Италия, 37134
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Канада, A1C 5B8
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St. John's, Newfoundland and Labrador, Канада, A1A 5E8
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Ontario
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Newmarket, Ontario, Канада, L3Y 3R7
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Waterloo, Ontario, Канада, N2J 1C4
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Quebec
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Trois-Rivieres, Quebec, Канада, G8Z 1Y2
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Bialystok, Польша, 15-351
- Novartis Investigative Site
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Warszawa, Польша, 02-341
- Novartis Investigative Site
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Ekaterinburg, Российская Федерация, 620109
- Novartis Investigative Site
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Ekaterinburg, Российская Федерация, 620028
- Novartis Investigative Site
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Kemerovo, Российская Федерация, 650029
- Novartis Investigative Site
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Moscow, Российская Федерация, 115522
- Novartis Investigative Site
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St Petersburg, Российская Федерация, 190068
- Novartis Investigative Site
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Yaroslavl, Российская Федерация, 150003
- Novartis Investigative Site
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Singapore, Сингапур, 119074
- Novartis Investigative Site
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Singapore, Сингапур, 529889
- Novartis Investigative Site
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Singapore, Сингапур, 169608
- Novartis Investigative Site
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Lucenec, Словакия, 984 01
- Novartis Investigative Site
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Glasgow, Соединенное Королевство, G31 2ER
- Novartis Investigative Site
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London, Соединенное Королевство, SE1 9RT
- Novartis Investigative Site
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London
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Leytonstone, London, Соединенное Королевство, E11 1NR
- Novartis Investigative Site
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Staffordshire
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Cannock, Staffordshire, Соединенное Королевство, WS11 2XY
- Novartis Investigative Site
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West Yorkshire
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Bradford, West Yorkshire, Соединенное Королевство, BD5 0NA
- Novartis Investigative Site
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Alabama
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Anniston, Alabama, Соединенные Штаты, 36207-5710
- Novartis Investigative Site
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Arizona
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Mesa, Arizona, Соединенные Штаты, 85202
- Novartis Investigative Site
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Paradise Valley, Arizona, Соединенные Штаты, 85253
- Novartis Investigative Site
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California
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Upland, California, Соединенные Штаты, 91786
- Novartis Investigative Site
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Florida
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Tamarac, Florida, Соединенные Штаты, 33321
- Novartis Investigative Site
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Minnesota
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Eagan, Minnesota, Соединенные Штаты, 55121
- Novartis Investigative Site
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Missouri
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Saint Louis, Missouri, Соединенные Штаты, 63117
- Novartis Investigative Site
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Nebraska
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Lincoln, Nebraska, Соединенные Штаты, 68516
- Novartis Investigative Site
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New Jersey
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Freehold, New Jersey, Соединенные Штаты, 07728
- Novartis Investigative Site
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North Carolina
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Charlotte, North Carolina, Соединенные Штаты, 28210
- Novartis Investigative Site
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73103
- Novartis Investigative Site
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Pennsylvania
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Duncansville, Pennsylvania, Соединенные Штаты, 16635
- Novartis Investigative Site
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South Carolina
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Charleston, South Carolina, Соединенные Штаты, 29460
- Novartis Investigative Site
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Columbia, South Carolina, Соединенные Штаты, 29204
- Novartis Investigative Site
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Tennessee
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Jackson, Tennessee, Соединенные Штаты, 38305
- Novartis Investigative Site
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Texas
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Benbrook, Texas, Соединенные Штаты, 76126
- Novartis Investigative Site
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Dallas, Texas, Соединенные Штаты, 75216
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Dallas, Texas, Соединенные Штаты, 75246
- Novartis Investigative Site
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Houston, Texas, Соединенные Штаты, 77074
- Novartis Investigative Site
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League City, Texas, Соединенные Штаты, 77573
- Novartis Investigative Site
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Mesquite, Texas, Соединенные Штаты, 75150
- Novartis Investigative Site
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Washington
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Seattle, Washington, Соединенные Штаты, 98122
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Bangkok, Таиланд, 10400
- Novartis Investigative Site
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Chiang Mai, Таиланд, 50200
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THA
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Khon Kaen, THA, Таиланд, 40002
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Las Pinas, Филиппины, 1740
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Manila, Филиппины, 1003
- Novartis Investigative Site
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Manila, Филиппины, 1008
- Novartis Investigative Site
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Quezon City, Филиппины, 1102
- Novartis Investigative Site
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Quezon City, Филиппины, 1118
- Novartis Investigative Site
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Batangas
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Lipa City, Batangas, Филиппины, 4217
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Cavite
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Dasmarinas, Cavite, Филиппины, 4114
- Novartis Investigative Site
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Metro Manila
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Manila, Metro Manila, Филиппины, 1003
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Czech Republic
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Bruntal, Czech Republic, Чехия, 792 01
- Novartis Investigative Site
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Uherske Hradiste, Czech Republic, Чехия, 686 01
- Novartis Investigative Site
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Zlin, Czech Republic, Чехия, 760 01
- Novartis Investigative Site
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion criteria
- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
- Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
- Subjects must be deemed by the investigator to benefit from continued secukinumab therapy
Exclusion criteria
- Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
- Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU)
Other protocol-defined inclusion/exclusion criteria may apply
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Secukinumab 75mg
Subjects continued to receive secukinumab 75mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256.
From Week 156, patients may have been escalated to 150 mg or 300 mg as judged appropriate by investigator
|
Secukinumab is a human monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces.
Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
Другие имена:
|
Экспериментальный: Secukinumab 150mg
Subjects continued to receive secukinumab 150mg in PFS (same dose as that was received in core study CAIN457F2306) every 4 weeks up to Week 256.
From Week 156, patients may have been escalated to 300 mg as judged appropriate by the investigator
|
Secukinumab is a human monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces.
Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
Другие имена:
|
Экспериментальный: Placebo - AIN457A 75mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 0.5 mL solution solution for injection was provided in PFS for s.c.
administration (a single use pre-filled 1mL long glass syringe).
It contained a mixture of inactive excipients, matching the composition of secukinumab 75mg
|
Плацебо
Другие имена:
Secukinumab is a human monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces.
Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
Другие имена:
|
Экспериментальный: Placebo - AIN457 150mg
Placebo (for maintaining the blind till Week 152): Placebo to secukinumab 1 mL solution for injection was provided in PFS for s.c.
administration (a single use pre-filled 1mL long glass syringe).
It contained a mixture of inactive excipients, matching the composition of secukinumab 150 mg
|
Плацебо
Другие имена:
Secukinumab is a human monoclonal antibody.
Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces.
Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Временное ограничение: weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:
|
weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Proportion of Subjects Who Reached ACR50
Временное ограничение: weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:
|
weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Proportion of Subjects Who Reached ACR70
Временное ограничение: weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain
|
weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Временное ограничение: weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability) |
weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
Временное ограничение: weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3).
The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.
|
weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Change From Baseline in Disease Activity Score-CRP (DAS28)
Временное ограничение: weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores. DAS28 is a combined measure of disease activity based on the following formula: DAS28-CRP = 0.56*TJC28^0.5 + 0.28*SJC28^0.5 + 0.36*ln(CRP+1) + 0.014*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP < 2.6 Low disease activity is defined as DAS28-CRP < 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score |
weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Percentage of Subjects Achieving Low Disease Activity
Временное ограничение: weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2).
The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity.
A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission
|
weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
Временное ограничение: weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Percentage of subjects achieving disease remission (DAS28<2.6).
The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity.
A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission
|
weeks 116, 128, 140, 156, 180, 208, 232 and 260
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CAIN457F2306E1
- 2013-001241-13 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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