Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (FUTURE 1 ext)
20. května 2019 aktualizováno: 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.
Přehled studie
Typ studie
Intervenční
Zápis (Aktuální)
460
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Buenos Aires, Argentina, C1417EYG
- Novartis Investigative Site
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Caba, Argentina, C1419AHN
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Cordoba, Argentina, X5016KEH
- Novartis Investigative Site
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Córdoba, Argentina, X5000EDC
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Buenos Aires
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Caba, Buenos Aires, Argentina, C1181ACH
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000CFJ
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Queensland
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Maroochydore, Queensland, Austrálie, 4558
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Victoria
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Malvern East, Victoria, Austrálie, 3145
- Novartis Investigative Site
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Genk, Belgie, 3600
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Gent, Belgie, 9000
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Leuven, Belgie, 3000
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazílie, 90610-000
- Novartis Investigative Site
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SP
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Sao Paulo, SP, Brazílie, 04023-900
- Novartis Investigative Site
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Sao Paulo, SP, Brazílie, 04266 010
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Pleven, Bulharsko, 5800
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Sofia, Bulharsko, 1612
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Gabrovo
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Sevlievo, Gabrovo, Bulharsko, 5400
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Las Pinas, Filipíny, 1740
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Manila, Filipíny, 1003
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Manila, Filipíny, 1008
- Novartis Investigative Site
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Quezon City, Filipíny, 1102
- Novartis Investigative Site
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Quezon City, Filipíny, 1118
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Batangas
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Lipa City, Batangas, Filipíny, 4217
- Novartis Investigative Site
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Cavite
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Dasmarinas, Cavite, Filipíny, 4114
- Novartis Investigative Site
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Metro Manila
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Manila, Metro Manila, Filipíny, 1003
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CT
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Catania, CT, Itálie, 95100
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PO
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Prato, PO, Itálie, 59100
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SI
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Siena, SI, Itálie, 53100
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VR
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Verona, VR, Itálie, 37134
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Ashkelon, Izrael, 78278
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Haifa, Izrael, 3339419
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Ramat Gan, Izrael, 5265601
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Tel Aviv, Izrael, 6423906
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Kanada, A1C 5B8
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St. John's, Newfoundland and Labrador, Kanada, A1A 5E8
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Ontario
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Newmarket, Ontario, Kanada, L3Y 3R7
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Waterloo, Ontario, Kanada, N2J 1C4
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Quebec
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Trois-Rivieres, Quebec, Kanada, G8Z 1Y2
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Aachen, Německo, 52064
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Erlangen, Německo, 91054
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Erlangen, Německo, 91056
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Gommern, Německo, 39245
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Hamburg, Německo, 22415
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Hildesheim, Německo, 31134
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Koeln, Německo, 50937
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Leipzig, Německo, 04103
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Nürnberg, Německo, 90429
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Ratingen, Německo, 40878
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Zerbst, Německo, 39261
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Bialystok, Polsko, 15-351
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Warszawa, Polsko, 02-341
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Ekaterinburg, Ruská Federace, 620109
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Ekaterinburg, Ruská Federace, 620028
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Kemerovo, Ruská Federace, 650029
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Moscow, Ruská Federace, 115522
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St Petersburg, Ruská Federace, 190068
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Yaroslavl, Ruská Federace, 150003
- Novartis Investigative Site
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Singapore, Singapur, 119074
- Novartis Investigative Site
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Singapore, Singapur, 529889
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Singapore, Singapur, 169608
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Lucenec, Slovensko, 984 01
- Novartis Investigative Site
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Glasgow, Spojené království, G31 2ER
- Novartis Investigative Site
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London, Spojené království, SE1 9RT
- Novartis Investigative Site
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London
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Leytonstone, London, Spojené království, E11 1NR
- Novartis Investigative Site
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Staffordshire
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Cannock, Staffordshire, Spojené království, WS11 2XY
- Novartis Investigative Site
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West Yorkshire
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Bradford, West Yorkshire, Spojené království, BD5 0NA
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Alabama
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Anniston, Alabama, Spojené státy, 36207-5710
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Arizona
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Mesa, Arizona, Spojené státy, 85202
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Paradise Valley, Arizona, Spojené státy, 85253
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California
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Upland, California, Spojené státy, 91786
- Novartis Investigative Site
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Florida
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Tamarac, Florida, Spojené státy, 33321
- Novartis Investigative Site
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Minnesota
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Eagan, Minnesota, Spojené státy, 55121
- Novartis Investigative Site
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Missouri
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Saint Louis, Missouri, Spojené státy, 63117
- Novartis Investigative Site
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Nebraska
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Lincoln, Nebraska, Spojené státy, 68516
- Novartis Investigative Site
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New Jersey
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Freehold, New Jersey, Spojené státy, 07728
- Novartis Investigative Site
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28210
- Novartis Investigative Site
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73103
- Novartis Investigative Site
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Pennsylvania
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Duncansville, Pennsylvania, Spojené státy, 16635
- Novartis Investigative Site
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South Carolina
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Charleston, South Carolina, Spojené státy, 29460
- Novartis Investigative Site
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Columbia, South Carolina, Spojené státy, 29204
- Novartis Investigative Site
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Tennessee
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Jackson, Tennessee, Spojené státy, 38305
- Novartis Investigative Site
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Texas
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Benbrook, Texas, Spojené státy, 76126
- Novartis Investigative Site
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Dallas, Texas, Spojené státy, 75216
- Novartis Investigative Site
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Dallas, Texas, Spojené státy, 75246
- Novartis Investigative Site
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Houston, Texas, Spojené státy, 77074
- Novartis Investigative Site
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League City, Texas, Spojené státy, 77573
- Novartis Investigative Site
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Mesquite, Texas, Spojené státy, 75150
- Novartis Investigative Site
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Washington
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Seattle, Washington, Spojené státy, 98122
- Novartis Investigative Site
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Bangkok, Thajsko, 10400
- Novartis Investigative Site
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Chiang Mai, Thajsko, 50200
- Novartis Investigative Site
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THA
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Khon Kaen, THA, Thajsko, 40002
- Novartis Investigative Site
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Czech Republic
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Bruntal, Czech Republic, Česko, 792 01
- Novartis Investigative Site
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Uherske Hradiste, Czech Republic, Česko, 686 01
- Novartis Investigative Site
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Zlin, Czech Republic, Česko, 760 01
- Novartis Investigative Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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).
Ostatní jména:
|
|
Experimentální: 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).
Ostatní jména:
|
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Experimentální: 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
Ostatní jména:
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).
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
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).
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Časové okno: 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
|
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Proportion of Subjects Who Reached ACR50
Časové okno: 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
|
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Proportion of Subjects Who Reached ACR70
Časové okno: 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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
30. září 2013
Primární dokončení (Aktuální)
11. ledna 2018
Dokončení studie (Aktuální)
11. ledna 2018
Termíny zápisu do studia
První předloženo
1. července 2013
První předloženo, které splnilo kritéria kontroly kvality
1. července 2013
První zveřejněno (Odhad)
4. července 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. června 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. května 2019
Naposledy ověřeno
1. května 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CAIN457F2306E1
- 2013-001241-13 (Číslo EudraCT)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NEROZHODNÝ
Popis plánu 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
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .