Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (FUTURE 1 ext)
20 mai 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
460
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Aachen, Allemagne, 52064
- Novartis Investigative Site
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Erlangen, Allemagne, 91054
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Erlangen, Allemagne, 91056
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Gommern, Allemagne, 39245
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Hamburg, Allemagne, 22415
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Hildesheim, Allemagne, 31134
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Koeln, Allemagne, 50937
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Leipzig, Allemagne, 04103
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Nürnberg, Allemagne, 90429
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Ratingen, Allemagne, 40878
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Zerbst, Allemagne, 39261
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Buenos Aires, Argentine, C1417EYG
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Caba, Argentine, C1419AHN
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Cordoba, Argentine, X5016KEH
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Córdoba, Argentine, X5000EDC
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Buenos Aires
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Caba, Buenos Aires, Argentine, C1181ACH
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Santa Fe
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Rosario, Santa Fe, Argentine, S2000CFJ
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Queensland
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Maroochydore, Queensland, Australie, 4558
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Victoria
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Malvern East, Victoria, Australie, 3145
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Genk, Belgique, 3600
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Gent, Belgique, 9000
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Leuven, Belgique, 3000
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brésil, 90610-000
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SP
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Sao Paulo, SP, Brésil, 04023-900
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Sao Paulo, SP, Brésil, 04266 010
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Pleven, Bulgarie, 5800
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Sofia, Bulgarie, 1612
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Gabrovo
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Sevlievo, Gabrovo, Bulgarie, 5400
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1C 5B8
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St. John's, Newfoundland and Labrador, Canada, A1A 5E8
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Ontario
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Newmarket, Ontario, Canada, L3Y 3R7
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Waterloo, Ontario, Canada, N2J 1C4
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Quebec
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Trois-Rivieres, Quebec, Canada, G8Z 1Y2
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Ekaterinburg, Fédération Russe, 620109
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Ekaterinburg, Fédération Russe, 620028
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Kemerovo, Fédération Russe, 650029
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Moscow, Fédération Russe, 115522
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St Petersburg, Fédération Russe, 190068
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Yaroslavl, Fédération Russe, 150003
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Ashkelon, Israël, 78278
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Haifa, Israël, 3339419
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Ramat Gan, Israël, 5265601
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Tel Aviv, Israël, 6423906
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CT
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Catania, CT, Italie, 95100
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PO
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Prato, PO, Italie, 59100
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SI
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Siena, SI, Italie, 53100
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VR
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Verona, VR, Italie, 37134
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Las Pinas, Philippines, 1740
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Manila, Philippines, 1003
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Manila, Philippines, 1008
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Quezon City, Philippines, 1102
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Quezon City, Philippines, 1118
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Batangas
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Lipa City, Batangas, Philippines, 4217
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Cavite
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Dasmarinas, Cavite, Philippines, 4114
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Metro Manila
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Manila, Metro Manila, Philippines, 1003
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Bialystok, Pologne, 15-351
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Warszawa, Pologne, 02-341
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Glasgow, Royaume-Uni, G31 2ER
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London, Royaume-Uni, SE1 9RT
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London
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Leytonstone, London, Royaume-Uni, E11 1NR
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Staffordshire
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Cannock, Staffordshire, Royaume-Uni, WS11 2XY
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West Yorkshire
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Bradford, West Yorkshire, Royaume-Uni, BD5 0NA
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Singapore, Singapour, 119074
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Singapore, Singapour, 529889
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Singapore, Singapour, 169608
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Lucenec, Slovaquie, 984 01
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Czech Republic
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Bruntal, Czech Republic, Tchéquie, 792 01
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Uherske Hradiste, Czech Republic, Tchéquie, 686 01
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Zlin, Czech Republic, Tchéquie, 760 01
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Bangkok, Thaïlande, 10400
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Chiang Mai, Thaïlande, 50200
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THA
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Khon Kaen, THA, Thaïlande, 40002
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Alabama
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Anniston, Alabama, États-Unis, 36207-5710
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Arizona
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Mesa, Arizona, États-Unis, 85202
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Paradise Valley, Arizona, États-Unis, 85253
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California
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Upland, California, États-Unis, 91786
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Florida
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Tamarac, Florida, États-Unis, 33321
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Minnesota
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Eagan, Minnesota, États-Unis, 55121
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Missouri
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Saint Louis, Missouri, États-Unis, 63117
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Nebraska
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Lincoln, Nebraska, États-Unis, 68516
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New Jersey
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Freehold, New Jersey, États-Unis, 07728
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North Carolina
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Charlotte, North Carolina, États-Unis, 28210
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73103
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Pennsylvania
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Duncansville, Pennsylvania, États-Unis, 16635
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South Carolina
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Charleston, South Carolina, États-Unis, 29460
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Columbia, South Carolina, États-Unis, 29204
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Tennessee
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Jackson, Tennessee, États-Unis, 38305
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Texas
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Benbrook, Texas, États-Unis, 76126
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Dallas, Texas, États-Unis, 75216
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Dallas, Texas, États-Unis, 75246
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Houston, Texas, États-Unis, 77074
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League City, Texas, États-Unis, 77573
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Mesquite, Texas, États-Unis, 75150
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Washington
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Seattle, Washington, États-Unis, 98122
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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).
Autres noms:
|
|
Expérimental: 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).
Autres noms:
|
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Expérimental: 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
Autres noms:
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).
Autres noms:
|
|
Expérimental: 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
Autres noms:
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).
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
|
weeks 116, 128, 140, 156, 180, 208, 232 and 260
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Percentage of Subjects Achieving Disease Remission (DAS28<2.6)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
30 septembre 2013
Achèvement primaire (Réel)
11 janvier 2018
Achèvement de l'étude (Réel)
11 janvier 2018
Dates d'inscription aux études
Première soumission
1 juillet 2013
Première soumission répondant aux critères de contrôle qualité
1 juillet 2013
Première publication (Estimation)
4 juillet 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 juin 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 mai 2019
Dernière vérification
1 mai 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CAIN457F2306E1
- 2013-001241-13 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime 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
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .