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

20 mei 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

460

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië, C1417EYG
        • Novartis Investigative Site
      • Caba, Argentinië, C1419AHN
        • Novartis Investigative Site
      • Cordoba, Argentinië, X5016KEH
        • Novartis Investigative Site
      • Córdoba, Argentinië, X5000EDC
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentinië, C1181ACH
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentinië, S2000CFJ
        • Novartis Investigative Site
  • Australië
    • Queensland
      • Maroochydore, Queensland, Australië, 4558
        • Novartis Investigative Site
    • Victoria
      • Malvern East, Victoria, Australië, 3145
        • Novartis Investigative Site
  • België
      • Genk, België, 3600
        • Novartis Investigative Site
      • Gent, België, 9000
        • Novartis Investigative Site
      • Leuven, België, 3000
        • Novartis Investigative Site
  • Brazilië
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazilië, 90610-000
        • Novartis Investigative Site
    • SP
      • Sao Paulo, SP, Brazilië, 04023-900
        • Novartis Investigative Site
      • Sao Paulo, SP, Brazilië, 04266 010
        • Novartis Investigative Site
  • Bulgarije
      • Pleven, Bulgarije, 5800
        • Novartis Investigative Site
      • Sofia, Bulgarije, 1612
        • Novartis Investigative Site
    • Gabrovo
      • Sevlievo, Gabrovo, Bulgarije, 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
  • Duitsland
      • Aachen, Duitsland, 52064
        • Novartis Investigative Site
      • Erlangen, Duitsland, 91054
        • Novartis Investigative Site
      • Erlangen, Duitsland, 91056
        • Novartis Investigative Site
      • Gommern, Duitsland, 39245
        • Novartis Investigative Site
      • Hamburg, Duitsland, 22415
        • Novartis Investigative Site
      • Hildesheim, Duitsland, 31134
        • Novartis Investigative Site
      • Koeln, Duitsland, 50937
        • Novartis Investigative Site
      • Leipzig, Duitsland, 04103
        • Novartis Investigative Site
      • Nürnberg, Duitsland, 90429
        • Novartis Investigative Site
      • Ratingen, Duitsland, 40878
        • Novartis Investigative Site
      • Zerbst, Duitsland, 39261
        • Novartis Investigative Site
  • Filippijnen
      • Las Pinas, Filippijnen, 1740
        • Novartis Investigative Site
      • Manila, Filippijnen, 1003
        • Novartis Investigative Site
      • Manila, Filippijnen, 1008
        • Novartis Investigative Site
      • Quezon City, Filippijnen, 1102
        • Novartis Investigative Site
      • Quezon City, Filippijnen, 1118
        • Novartis Investigative Site
    • Batangas
      • Lipa City, Batangas, Filippijnen, 4217
        • Novartis Investigative Site
    • Cavite
      • Dasmarinas, Cavite, Filippijnen, 4114
        • Novartis Investigative Site
    • Metro Manila
      • Manila, Metro Manila, Filippijnen, 1003
        • Novartis Investigative Site
  • Israël
      • Ashkelon, Israël, 78278
        • Novartis Investigative Site
      • Haifa, Israël, 3339419
        • Novartis Investigative Site
      • Ramat Gan, Israël, 5265601
        • Novartis Investigative Site
      • Tel Aviv, Israël, 6423906
        • Novartis Investigative Site
  • Italië
    • CT
      • Catania, CT, Italië, 95100
        • Novartis Investigative Site
    • PO
      • Prato, PO, Italië, 59100
        • Novartis Investigative Site
    • SI
      • Siena, SI, Italië, 53100
        • Novartis Investigative Site
    • VR
      • Verona, VR, Italië, 37134
        • Novartis Investigative Site
  • Polen
      • Bialystok, Polen, 15-351
        • Novartis Investigative Site
      • Warszawa, Polen, 02-341
        • Novartis Investigative Site
  • Russische Federatie
      • Ekaterinburg, Russische Federatie, 620109
        • Novartis Investigative Site
      • Ekaterinburg, Russische Federatie, 620028
        • Novartis Investigative Site
      • Kemerovo, Russische Federatie, 650029
        • Novartis Investigative Site
      • Moscow, Russische Federatie, 115522
        • Novartis Investigative Site
      • St Petersburg, Russische Federatie, 190068
        • Novartis Investigative Site
      • Yaroslavl, Russische Federatie, 150003
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Novartis Investigative Site
      • Singapore, Singapore, 529889
        • Novartis Investigative Site
      • Singapore, Singapore, 169608
        • Novartis Investigative Site
  • Slowakije
      • Lucenec, Slowakije, 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
  • Tsjechië
    • Czech Republic
      • Bruntal, Czech Republic, Tsjechië, 792 01
        • Novartis Investigative Site
      • Uherske Hradiste, Czech Republic, Tsjechië, 686 01
        • Novartis Investigative Site
      • Zlin, Czech Republic, Tsjechië, 760 01
        • Novartis Investigative Site
  • Verenigd Koninkrijk
      • Glasgow, Verenigd Koninkrijk, G31 2ER
        • Novartis Investigative Site
      • London, Verenigd Koninkrijk, SE1 9RT
        • Novartis Investigative Site
    • London
      • Leytonstone, London, Verenigd Koninkrijk, E11 1NR
        • Novartis Investigative Site
    • Staffordshire
      • Cannock, Staffordshire, Verenigd Koninkrijk, WS11 2XY
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, Verenigd Koninkrijk, BD5 0NA
        • Novartis Investigative Site
  • Verenigde Staten
    • Alabama
      • Anniston, Alabama, Verenigde Staten, 36207-5710
        • Novartis Investigative Site
    • Arizona
      • Mesa, Arizona, Verenigde Staten, 85202
        • Novartis Investigative Site
      • Paradise Valley, Arizona, Verenigde Staten, 85253
        • Novartis Investigative Site
    • California
      • Upland, California, Verenigde Staten, 91786
        • Novartis Investigative Site
    • Florida
      • Tamarac, Florida, Verenigde Staten, 33321
        • Novartis Investigative Site
    • Minnesota
      • Eagan, Minnesota, Verenigde Staten, 55121
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, Verenigde Staten, 63117
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, Verenigde Staten, 68516
        • Novartis Investigative Site
    • New Jersey
      • Freehold, New Jersey, Verenigde Staten, 07728
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, Verenigde Staten, 28210
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Verenigde Staten, 73103
        • Novartis Investigative Site
    • Pennsylvania
      • Duncansville, Pennsylvania, Verenigde Staten, 16635
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29460
        • Novartis Investigative Site
      • Columbia, South Carolina, Verenigde Staten, 29204
        • Novartis Investigative Site
    • Tennessee
      • Jackson, Tennessee, Verenigde Staten, 38305
        • Novartis Investigative Site
    • Texas
      • Benbrook, Texas, Verenigde Staten, 76126
        • Novartis Investigative Site
      • Dallas, Texas, Verenigde Staten, 75216
        • Novartis Investigative Site
      • Dallas, Texas, Verenigde Staten, 75246
        • Novartis Investigative Site
      • Houston, Texas, Verenigde Staten, 77074
        • Novartis Investigative Site
      • League City, Texas, Verenigde Staten, 77573
        • Novartis Investigative Site
      • Mesquite, Texas, Verenigde Staten, 75150
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, Verenigde Staten, 98122
        • Novartis Investigative Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Geneesmiddel: 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).
Andere namen:
  • AIN457
Experimenteel: 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
Geneesmiddel: 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).
Andere namen:
  • AIN457
Experimenteel: 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
Geneesmiddel: Placebo
Placebo
Andere namen:
  • Placebo-AIN457A
Geneesmiddel: 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).
Andere namen:
  • AIN457
Experimenteel: 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
Geneesmiddel: Placebo
Placebo
Andere namen:
  • Placebo-AIN457A
Geneesmiddel: 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).
Andere namen:
  • AIN457

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Novartis Pharmaceuticals

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 september 2013

Primaire voltooiing (Werkelijk)

11 januari 2018

Studie voltooiing (Werkelijk)

11 januari 2018

Studieregistratiedata

Eerst ingediend

1 juli 2013

Eerst ingediend dat voldeed aan de QC-criteria

1 juli 2013

Eerst geplaatst (Schatting)

4 juli 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 juni 2019

Laatste update ingediend die voldeed aan QC-criteria

20 mei 2019

Laatst geverifieerd

1 mei 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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