Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

20. maj 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

460

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Australien
    • Queensland
      • Maroochydore, Queensland, Australien, 4558
        • Novartis Investigative Site
    • Victoria
      • Malvern East, Victoria, Australien, 3145
        • Novartis Investigative Site
  • Belgien
      • Genk, Belgien, 3600
        • Novartis Investigative Site
      • Gent, Belgien, 9000
        • Novartis Investigative Site
      • Leuven, Belgien, 3000
        • Novartis Investigative Site
  • Brasilien
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 90610-000
        • Novartis Investigative Site
    • SP
      • Sao Paulo, SP, Brasilien, 04023-900
        • Novartis Investigative Site
      • Sao Paulo, SP, Brasilien, 04266 010
        • Novartis Investigative Site
  • Bulgarien
      • Pleven, Bulgarien, 5800
        • Novartis Investigative Site
      • Sofia, Bulgarien, 1612
        • Novartis Investigative Site
    • Gabrovo
      • Sevlievo, Gabrovo, Bulgarien, 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
  • Den Russiske Føderation
      • Ekaterinburg, Den Russiske Føderation, 620109
        • Novartis Investigative Site
      • Ekaterinburg, Den Russiske Føderation, 620028
        • Novartis Investigative Site
      • Kemerovo, Den Russiske Føderation, 650029
        • Novartis Investigative Site
      • Moscow, Den Russiske Føderation, 115522
        • Novartis Investigative Site
      • St Petersburg, Den Russiske Føderation, 190068
        • Novartis Investigative Site
      • Yaroslavl, Den Russiske Føderation, 150003
        • Novartis Investigative Site
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige, G31 2ER
        • Novartis Investigative Site
      • London, Det Forenede Kongerige, SE1 9RT
        • Novartis Investigative Site
    • London
      • Leytonstone, London, Det Forenede Kongerige, E11 1NR
        • Novartis Investigative Site
    • Staffordshire
      • Cannock, Staffordshire, Det Forenede Kongerige, WS11 2XY
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, Det Forenede Kongerige, BD5 0NA
        • Novartis Investigative Site
  • Filippinerne
      • Las Pinas, Filippinerne, 1740
        • Novartis Investigative Site
      • Manila, Filippinerne, 1003
        • Novartis Investigative Site
      • Manila, Filippinerne, 1008
        • Novartis Investigative Site
      • Quezon City, Filippinerne, 1102
        • Novartis Investigative Site
      • Quezon City, Filippinerne, 1118
        • Novartis Investigative Site
    • Batangas
      • Lipa City, Batangas, Filippinerne, 4217
        • Novartis Investigative Site
    • Cavite
      • Dasmarinas, Cavite, Filippinerne, 4114
        • Novartis Investigative Site
    • Metro Manila
      • Manila, Metro Manila, Filippinerne, 1003
        • Novartis Investigative Site
  • Forenede Stater
    • Alabama
      • Anniston, Alabama, Forenede Stater, 36207-5710
        • Novartis Investigative Site
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85202
        • Novartis Investigative Site
      • Paradise Valley, Arizona, Forenede Stater, 85253
        • Novartis Investigative Site
    • California
      • Upland, California, Forenede Stater, 91786
        • Novartis Investigative Site
    • Florida
      • Tamarac, Florida, Forenede Stater, 33321
        • Novartis Investigative Site
    • Minnesota
      • Eagan, Minnesota, Forenede Stater, 55121
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63117
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68516
        • Novartis Investigative Site
    • New Jersey
      • Freehold, New Jersey, Forenede Stater, 07728
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28210
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73103
        • Novartis Investigative Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Forenede Stater, 16635
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29460
        • Novartis Investigative Site
      • Columbia, South Carolina, Forenede Stater, 29204
        • Novartis Investigative Site
    • Tennessee
      • Jackson, Tennessee, Forenede Stater, 38305
        • Novartis Investigative Site
    • Texas
      • Benbrook, Texas, Forenede Stater, 76126
        • Novartis Investigative Site
      • Dallas, Texas, Forenede Stater, 75216
        • Novartis Investigative Site
      • Dallas, Texas, Forenede Stater, 75246
        • Novartis Investigative Site
      • Houston, Texas, Forenede Stater, 77074
        • Novartis Investigative Site
      • League City, Texas, Forenede Stater, 77573
        • Novartis Investigative Site
      • Mesquite, Texas, Forenede Stater, 75150
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, Forenede Stater, 98122
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel, 78278
        • Novartis Investigative Site
      • Haifa, Israel, 3339419
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Novartis Investigative Site
  • Italien
    • CT
      • Catania, CT, Italien, 95100
        • Novartis Investigative Site
    • PO
      • Prato, PO, Italien, 59100
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italien, 53100
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italien, 37134
        • Novartis Investigative Site
  • Polen
      • Bialystok, Polen, 15-351
        • Novartis Investigative Site
      • Warszawa, Polen, 02-341
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 529889
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
  • Slovakiet
      • Lucenec, Slovakiet, 984 01
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Novartis Investigative Site
    • THA
      • Khon Kaen, THA, Thailand, 40002
        • Novartis Investigative Site
  • Tjekkiet
    • Czech Republic
      • Bruntal, Czech Republic, Tjekkiet, 792 01
        • Novartis Investigative Site
      • Uherske Hradiste, Czech Republic, Tjekkiet, 686 01
        • Novartis Investigative Site
      • Zlin, Czech Republic, Tjekkiet, 760 01
        • Novartis Investigative Site
  • Tyskland
      • Aachen, Tyskland, 52064
        • Novartis Investigative Site
      • Erlangen, Tyskland, 91054
        • Novartis Investigative Site
      • Erlangen, Tyskland, 91056
        • Novartis Investigative Site
      • Gommern, Tyskland, 39245
        • Novartis Investigative Site
      • Hamburg, Tyskland, 22415
        • Novartis Investigative Site
      • Hildesheim, Tyskland, 31134
        • Novartis Investigative Site
      • Koeln, Tyskland, 50937
        • Novartis Investigative Site
      • Leipzig, Tyskland, 04103
        • Novartis Investigative Site
      • Nürnberg, Tyskland, 90429
        • Novartis Investigative Site
      • Ratingen, Tyskland, 40878
        • Novartis Investigative Site
      • Zerbst, Tyskland, 39261
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: 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).
Andre navne:
  • AIN457
Eksperimentel: 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
Medicin: 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).
Andre navne:
  • AIN457
Eksperimentel: 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
Medicin: Placebo
Placebo
Andre navne:
  • Placebo - AIN457A
Medicin: 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).
Andre navne:
  • AIN457
Eksperimentel: 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
Medicin: Placebo
Placebo
Andre navne:
  • Placebo - AIN457A
Medicin: 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).
Andre navne:
  • AIN457

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. september 2013

Primær færdiggørelse (Faktiske)

11. januar 2018

Studieafslutning (Faktiske)

11. januar 2018

Datoer for studieregistrering

Først indsendt

1. juli 2013

Først indsendt, der opfyldte QC-kriterier

1. juli 2013

Først opslået (Skøn)

4. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Psoriasisgigt

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Morocco

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner