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Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis (FUTURE 1 ext)

20 maggio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

460

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Buenos Aires, Argentina, C1417EYG
        • Novartis Investigative Site
      • Caba, Argentina, C1419AHN
        • Novartis Investigative Site
      • Cordoba, Argentina, X5016KEH
        • Novartis Investigative Site
      • Córdoba, Argentina, X5000EDC
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1181ACH
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CFJ
        • Novartis Investigative Site
  • Australia
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Novartis Investigative Site
    • Victoria
      • Malvern East, Victoria, Australia, 3145
        • Novartis Investigative Site
  • Belgio
      • Genk, Belgio, 3600
        • Novartis Investigative Site
      • Gent, Belgio, 9000
        • Novartis Investigative Site
      • Leuven, Belgio, 3000
        • Novartis Investigative Site
  • Brasile
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasile, 90610-000
        • Novartis Investigative Site
    • SP
      • Sao Paulo, SP, Brasile, 04023-900
        • Novartis Investigative Site
      • Sao Paulo, SP, Brasile, 04266 010
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1612
        • Novartis Investigative Site
    • Gabrovo
      • Sevlievo, Gabrovo, Bulgaria, 5400
        • Novartis Investigative Site
  • Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • Novartis Investigative Site
      • St. John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Novartis Investigative Site
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 3R7
        • Novartis Investigative Site
      • Waterloo, Ontario, Canada, N2J 1C4
        • Novartis Investigative Site
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Novartis Investigative Site
  • Cechia
    • Czech Republic
      • Bruntal, Czech Republic, Cechia, 792 01
        • Novartis Investigative Site
      • Uherske Hradiste, Czech Republic, Cechia, 686 01
        • Novartis Investigative Site
      • Zlin, Czech Republic, Cechia, 760 01
        • Novartis Investigative Site
  • Federazione Russa
      • Ekaterinburg, Federazione Russa, 620109
        • Novartis Investigative Site
      • Ekaterinburg, Federazione Russa, 620028
        • Novartis Investigative Site
      • Kemerovo, Federazione Russa, 650029
        • Novartis Investigative Site
      • Moscow, Federazione Russa, 115522
        • Novartis Investigative Site
      • St Petersburg, Federazione Russa, 190068
        • Novartis Investigative Site
      • Yaroslavl, Federazione Russa, 150003
        • Novartis Investigative Site
  • Filippine
      • Las Pinas, Filippine, 1740
        • Novartis Investigative Site
      • Manila, Filippine, 1003
        • Novartis Investigative Site
      • Manila, Filippine, 1008
        • Novartis Investigative Site
      • Quezon City, Filippine, 1102
        • Novartis Investigative Site
      • Quezon City, Filippine, 1118
        • Novartis Investigative Site
    • Batangas
      • Lipa City, Batangas, Filippine, 4217
        • Novartis Investigative Site
    • Cavite
      • Dasmarinas, Cavite, Filippine, 4114
        • Novartis Investigative Site
    • Metro Manila
      • Manila, Metro Manila, Filippine, 1003
        • Novartis Investigative Site
  • Germania
      • Aachen, Germania, 52064
        • Novartis Investigative Site
      • Erlangen, Germania, 91054
        • Novartis Investigative Site
      • Erlangen, Germania, 91056
        • Novartis Investigative Site
      • Gommern, Germania, 39245
        • Novartis Investigative Site
      • Hamburg, Germania, 22415
        • Novartis Investigative Site
      • Hildesheim, Germania, 31134
        • Novartis Investigative Site
      • Koeln, Germania, 50937
        • Novartis Investigative Site
      • Leipzig, Germania, 04103
        • Novartis Investigative Site
      • Nürnberg, Germania, 90429
        • Novartis Investigative Site
      • Ratingen, Germania, 40878
        • Novartis Investigative Site
      • Zerbst, Germania, 39261
        • Novartis Investigative Site
  • Israele
      • Ashkelon, Israele, 78278
        • Novartis Investigative Site
      • Haifa, Israele, 3339419
        • Novartis Investigative Site
      • Ramat Gan, Israele, 5265601
        • Novartis Investigative Site
      • Tel Aviv, Israele, 6423906
        • Novartis Investigative Site
  • Italia
    • CT
      • Catania, CT, Italia, 95100
        • Novartis Investigative Site
    • PO
      • Prato, PO, Italia, 59100
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italia, 53100
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italia, 37134
        • Novartis Investigative Site
  • Polonia
      • Bialystok, Polonia, 15-351
        • Novartis Investigative Site
      • Warszawa, Polonia, 02-341
        • Novartis Investigative Site
  • Regno Unito
      • Glasgow, Regno Unito, G31 2ER
        • Novartis Investigative Site
      • London, Regno Unito, SE1 9RT
        • Novartis Investigative Site
    • London
      • Leytonstone, London, Regno Unito, E11 1NR
        • Novartis Investigative Site
    • Staffordshire
      • Cannock, Staffordshire, Regno Unito, WS11 2XY
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, Regno Unito, BD5 0NA
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 529889
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
  • Slovacchia
      • Lucenec, Slovacchia, 984 01
        • Novartis Investigative Site
  • Stati Uniti
    • Alabama
      • Anniston, Alabama, Stati Uniti, 36207-5710
        • Novartis Investigative Site
    • Arizona
      • Mesa, Arizona, Stati Uniti, 85202
        • Novartis Investigative Site
      • Paradise Valley, Arizona, Stati Uniti, 85253
        • Novartis Investigative Site
    • California
      • Upland, California, Stati Uniti, 91786
        • Novartis Investigative Site
    • Florida
      • Tamarac, Florida, Stati Uniti, 33321
        • Novartis Investigative Site
    • Minnesota
      • Eagan, Minnesota, Stati Uniti, 55121
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, Stati Uniti, 63117
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, Stati Uniti, 68516
        • Novartis Investigative Site
    • New Jersey
      • Freehold, New Jersey, Stati Uniti, 07728
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, Stati Uniti, 28210
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73103
        • Novartis Investigative Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Stati Uniti, 16635
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29460
        • Novartis Investigative Site
      • Columbia, South Carolina, Stati Uniti, 29204
        • Novartis Investigative Site
    • Tennessee
      • Jackson, Tennessee, Stati Uniti, 38305
        • Novartis Investigative Site
    • Texas
      • Benbrook, Texas, Stati Uniti, 76126
        • Novartis Investigative Site
      • Dallas, Texas, Stati Uniti, 75216
        • Novartis Investigative Site
      • Dallas, Texas, Stati Uniti, 75246
        • Novartis Investigative Site
      • Houston, Texas, Stati Uniti, 77074
        • Novartis Investigative Site
      • League City, Texas, Stati Uniti, 77573
        • Novartis Investigative Site
      • Mesquite, Texas, Stati Uniti, 75150
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, Stati Uniti, 98122
        • Novartis Investigative Site
  • Tailandia
      • Bangkok, Tailandia, 10400
        • Novartis Investigative Site
      • Chiang Mai, Tailandia, 50200
        • Novartis Investigative Site
    • THA
      • Khon Kaen, THA, Tailandia, 40002
        • Novartis Investigative Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: Secukinumab
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).
Altri nomi:
  • AIN457
Sperimentale: 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
Droga: Secukinumab
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).
Altri nomi:
  • AIN457
Sperimentale: 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
Droga: Placebo
Placebo
Altri nomi:
  • Placebo - AIN457A
Droga: Secukinumab
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).
Altri nomi:
  • AIN457
Sperimentale: 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
Droga: Placebo
Placebo
Altri nomi:
  • Placebo - AIN457A
Droga: Secukinumab
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).
Altri nomi:
  • AIN457

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Lasso di tempo: 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:

  • Patient's assessment of Psoriatic Arthritis (PsA) pain
  • Patient's global assessment of disease activity
  • Physician's global assessment of disease activity
  • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
  • Acute phase reactant (hsCRP or ESR)
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of Subjects Who Reached ACR50
Lasso di tempo: 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:

  • Patient's assessment of PsA pain
  • Patient's global assessment of disease activity
  • Physician's global assessment of disease activity
  • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
  • Acute phase reactant (hsCRP or ESR)
weeks 116, 128, 140, 156, 180, 208, 232 and 260
Proportion of Subjects Who Reached ACR70
Lasso di tempo: 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

  • Patient's global assessment of disease activity
  • Physician's global assessment of disease activity
  • Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)
  • Acute phase reactant (hsCRP or ESR)
weeks 116, 128, 140, 156, 180, 208, 232 and 260

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 settembre 2013

Completamento primario (Effettivo)

11 gennaio 2018

Completamento dello studio (Effettivo)

11 gennaio 2018

Date di iscrizione allo studio

Primo inviato

1 luglio 2013

Primo inviato che soddisfa i criteri di controllo qualità

1 luglio 2013

Primo Inserito (Stima)

4 luglio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 giugno 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 maggio 2019

Ultimo verificato

1 maggio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CAIN457F2306E1
  • 2013-001241-13 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano 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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sedi

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