Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (FUTURE 1 ext)
20 de mayo de 2019 actualizado por: Novartis Pharmaceuticals
A Three-year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Psoriatic Arthritis
This study was designed as a 3-year extension to the phase III core study CAIN457F2306.
It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks.
At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study.
The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
460
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Aachen, Alemania, 52064
- Novartis Investigative Site
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Erlangen, Alemania, 91054
- Novartis Investigative Site
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Erlangen, Alemania, 91056
- Novartis Investigative Site
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Gommern, Alemania, 39245
- Novartis Investigative Site
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Hamburg, Alemania, 22415
- Novartis Investigative Site
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Hildesheim, Alemania, 31134
- Novartis Investigative Site
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Koeln, Alemania, 50937
- Novartis Investigative Site
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Leipzig, Alemania, 04103
- Novartis Investigative Site
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Nürnberg, Alemania, 90429
- Novartis Investigative Site
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Ratingen, Alemania, 40878
- Novartis Investigative Site
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Zerbst, Alemania, 39261
- Novartis Investigative Site
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Buenos Aires, Argentina, C1417EYG
- Novartis Investigative Site
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Caba, Argentina, C1419AHN
- Novartis Investigative Site
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Cordoba, Argentina, X5016KEH
- Novartis Investigative Site
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Córdoba, Argentina, X5000EDC
- Novartis Investigative Site
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Buenos Aires
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Caba, Buenos Aires, Argentina, C1181ACH
- Novartis Investigative Site
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000CFJ
- Novartis Investigative Site
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Queensland
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Maroochydore, Queensland, Australia, 4558
- Novartis Investigative Site
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Victoria
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Malvern East, Victoria, Australia, 3145
- Novartis Investigative Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasil, 90610-000
- Novartis Investigative Site
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SP
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Sao Paulo, SP, Brasil, 04023-900
- Novartis Investigative Site
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Sao Paulo, SP, Brasil, 04266 010
- Novartis Investigative Site
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Pleven, Bulgaria, 5800
- Novartis Investigative Site
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Sofia, Bulgaria, 1612
- Novartis Investigative Site
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Gabrovo
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Sevlievo, Gabrovo, Bulgaria, 5400
- Novartis Investigative Site
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Genk, Bélgica, 3600
- Novartis Investigative Site
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Gent, Bélgica, 9000
- Novartis Investigative Site
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Leuven, Bélgica, 3000
- Novartis Investigative Site
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canadá, A1C 5B8
- Novartis Investigative Site
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St. John's, Newfoundland and Labrador, Canadá, A1A 5E8
- Novartis Investigative Site
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Ontario
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Newmarket, Ontario, Canadá, L3Y 3R7
- Novartis Investigative Site
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Waterloo, Ontario, Canadá, N2J 1C4
- Novartis Investigative Site
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Quebec
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Trois-Rivieres, Quebec, Canadá, G8Z 1Y2
- Novartis Investigative Site
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Czech Republic
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Bruntal, Czech Republic, Chequia, 792 01
- Novartis Investigative Site
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Uherske Hradiste, Czech Republic, Chequia, 686 01
- Novartis Investigative Site
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Zlin, Czech Republic, Chequia, 760 01
- Novartis Investigative Site
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Lucenec, Eslovaquia, 984 01
- Novartis Investigative Site
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Alabama
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Anniston, Alabama, Estados Unidos, 36207-5710
- Novartis Investigative Site
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Arizona
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Mesa, Arizona, Estados Unidos, 85202
- Novartis Investigative Site
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Paradise Valley, Arizona, Estados Unidos, 85253
- Novartis Investigative Site
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California
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Upland, California, Estados Unidos, 91786
- Novartis Investigative Site
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Florida
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Tamarac, Florida, Estados Unidos, 33321
- Novartis Investigative Site
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Minnesota
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Eagan, Minnesota, Estados Unidos, 55121
- Novartis Investigative Site
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63117
- Novartis Investigative Site
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68516
- Novartis Investigative Site
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New Jersey
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Freehold, New Jersey, Estados Unidos, 07728
- Novartis Investigative Site
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28210
- Novartis Investigative Site
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73103
- Novartis Investigative Site
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Pennsylvania
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Duncansville, Pennsylvania, Estados Unidos, 16635
- Novartis Investigative Site
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29460
- Novartis Investigative Site
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Columbia, South Carolina, Estados Unidos, 29204
- Novartis Investigative Site
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Tennessee
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Jackson, Tennessee, Estados Unidos, 38305
- Novartis Investigative Site
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Texas
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Benbrook, Texas, Estados Unidos, 76126
- Novartis Investigative Site
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Dallas, Texas, Estados Unidos, 75216
- Novartis Investigative Site
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Dallas, Texas, Estados Unidos, 75246
- Novartis Investigative Site
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Houston, Texas, Estados Unidos, 77074
- Novartis Investigative Site
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League City, Texas, Estados Unidos, 77573
- Novartis Investigative Site
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Mesquite, Texas, Estados Unidos, 75150
- Novartis Investigative Site
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Washington
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Seattle, Washington, Estados Unidos, 98122
- Novartis Investigative Site
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Ekaterinburg, Federación Rusa, 620109
- Novartis Investigative Site
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Ekaterinburg, Federación Rusa, 620028
- Novartis Investigative Site
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Kemerovo, Federación Rusa, 650029
- Novartis Investigative Site
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Moscow, Federación Rusa, 115522
- Novartis Investigative Site
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St Petersburg, Federación Rusa, 190068
- Novartis Investigative Site
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Yaroslavl, Federación Rusa, 150003
- Novartis Investigative Site
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Las Pinas, Filipinas, 1740
- Novartis Investigative Site
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Manila, Filipinas, 1003
- Novartis Investigative Site
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Manila, Filipinas, 1008
- Novartis Investigative Site
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Quezon City, Filipinas, 1102
- Novartis Investigative Site
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Quezon City, Filipinas, 1118
- Novartis Investigative Site
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Batangas
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Lipa City, Batangas, Filipinas, 4217
- Novartis Investigative Site
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Cavite
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Dasmarinas, Cavite, Filipinas, 4114
- Novartis Investigative Site
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Metro Manila
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Manila, Metro Manila, Filipinas, 1003
- Novartis Investigative Site
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Ashkelon, Israel, 78278
- Novartis Investigative Site
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Haifa, Israel, 3339419
- Novartis Investigative Site
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Ramat Gan, Israel, 5265601
- Novartis Investigative Site
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Tel Aviv, Israel, 6423906
- Novartis Investigative Site
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CT
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Catania, CT, Italia, 95100
- Novartis Investigative Site
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PO
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Prato, PO, Italia, 59100
- Novartis Investigative Site
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SI
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Siena, SI, Italia, 53100
- Novartis Investigative Site
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VR
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Verona, VR, Italia, 37134
- Novartis Investigative Site
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Bialystok, Polonia, 15-351
- Novartis Investigative Site
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Warszawa, Polonia, 02-341
- Novartis Investigative Site
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Glasgow, Reino Unido, G31 2ER
- Novartis Investigative Site
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London, Reino Unido, SE1 9RT
- Novartis Investigative Site
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London
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Leytonstone, London, Reino Unido, E11 1NR
- Novartis Investigative Site
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Staffordshire
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Cannock, Staffordshire, Reino Unido, WS11 2XY
- Novartis Investigative Site
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West Yorkshire
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Bradford, West Yorkshire, Reino Unido, BD5 0NA
- Novartis Investigative Site
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Singapore, Singapur, 119074
- Novartis Investigative Site
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Singapore, Singapur, 529889
- Novartis Investigative Site
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Singapore, Singapur, 169608
- Novartis Investigative Site
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Bangkok, Tailandia, 10400
- Novartis Investigative Site
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Chiang Mai, Tailandia, 50200
- Novartis Investigative Site
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THA
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Khon Kaen, THA, Tailandia, 40002
- Novartis Investigative Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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
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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).
Otros nombres:
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Experimental: 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
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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).
Otros nombres:
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Experimental: 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
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Placebo
Otros nombres:
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).
Otros nombres:
|
|
Experimental: 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
|
Placebo
Otros nombres:
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).
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Periodo de tiempo: weeks 116, 128, 140, 156, 180, 208, 232 and 260
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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:
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Proportion of Subjects Who Reached ACR50
Periodo de tiempo: weeks 116, 128, 140, 156, 180, 208, 232 and 260
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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:
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Proportion of Subjects Who Reached ACR70
Periodo de tiempo: weeks 116, 128, 140, 156, 180, 208, 232 and 260
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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
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Periodo de tiempo: weeks 116, 128, 140, 156, 180, 208, 232 and 260
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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
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Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
Periodo de tiempo: weeks 116, 128, 140, 156, 180, 208, 232 and 260
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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.
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Change From Baseline in Disease Activity Score-CRP (DAS28)
Periodo de tiempo: weeks 116, 128, 140, 156, 180, 208, 232 and 260
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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
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Percentage of Subjects Achieving Low Disease Activity
Periodo de tiempo: weeks 116, 128, 140, 156, 180, 208, 232 and 260
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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
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weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
Periodo de tiempo: weeks 116, 128, 140, 156, 180, 208, 232 and 260
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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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de septiembre de 2013
Finalización primaria (Actual)
11 de enero de 2018
Finalización del estudio (Actual)
11 de enero de 2018
Fechas de registro del estudio
Enviado por primera vez
1 de julio de 2013
Primero enviado que cumplió con los criterios de control de calidad
1 de julio de 2013
Publicado por primera vez (Estimar)
4 de julio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
20 de mayo de 2019
Última verificación
1 de mayo de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CAIN457F2306E1
- 2013-001241-13 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .