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Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) (β-SPECIFIC 1)

28 februari 2017 bijgewerkt door: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

84

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
        • Novartis Investigative Site
      • Capital Federal, Argentinië
        • Novartis Investigative Site
      • La Plata, Argentinië
        • Novartis Investigative Site
  • België
      • Bruxelles, België
        • Novartis Investigative Site
      • Gent, België
        • Novartis Investigative Site
      • Laeken, België
        • Novartis Investigative Site
      • Leuven, België
        • Novartis Investigative Site
  • Brazilië
      • Curitiba, Brazilië
        • Novartis Investigative Site
      • Porto Alegre, Brazilië
        • Novartis Investigative Site
      • Rio de Janeiro, Brazilië
        • Novartis Investigative Site
      • Sao Paulo, Brazilië
        • Novartis Investigative Site
  • Canada
      • Calgary, Canada
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada
        • Novartis Investigative Site
  • Denemarken
      • Arhus N, Denemarken
        • Novartis Investigative Site
  • Duitsland
      • Bad Bamstedt, Duitsland
        • Novartis Investigative Site
      • Berlin, Duitsland
        • Novartis Investigative Site
      • Bremen, Duitsland
        • Novartis Investigative Site
      • Dresden, Duitsland
        • Novartis Investigative Site
      • Freiburg, Duitsland
        • Novartis Investigative Site
      • Garmisch-Partenkirch, Duitsland
        • Novartis Investigative Site
      • Geissen, Duitsland
        • Novartis Investigative Site
      • Hamburg, Duitsland
        • Novartis Investigative Site
      • Hannover, Duitsland
        • Novartis Investigative Site
      • Krefeld, Duitsland
        • Novartis Investigative Site
      • Mainz, Duitsland
        • Novartis Investigative Site
      • Muenster, Duitsland
        • Novartis Investigative Site
      • Saint Augustin, Duitsland
        • Novartis Investigative Site
      • Stuttgart, Duitsland
        • Novartis Investigative Site
      • Tubingen, Duitsland
        • Novartis Investigative Site
  • Frankrijk
      • Le Kremlin Bicetre, Frankrijk
        • Novartis Investigative Site
      • Lyon, Frankrijk
        • Novartis Investigative Site
      • Paris, Frankrijk
        • Novartis Investigative Site
      • Strassbourg, Frankrijk
        • Novartis Investigative Site
  • Griekenland
      • Thessaloniki, Griekenland
        • Novartis Investigative Site
  • Hongarije
      • Budapest, Hongarije
        • Novartis Investigative Site
  • Israël
      • Haifa, Israël
        • Novartis Investigative Site
      • Kfar Saba, Israël
        • Novartis Investigative Site
      • Petach-Tikva, Israël
        • Novartis Investigative Site
      • Ramat Gan, Israël
        • Novartis Investigative Site
      • Rehovot, Israël
        • Novartis Investigative Site
  • Italië
      • Bologna, Italië
        • Novartis Investigative Site
      • Firenze, Italië
        • Novartis Investigative Site
      • Genova, Italië
        • Novartis Investigative Site
      • Milano, Italië
        • Novartis Investigative Site
      • Napoli, Italië
        • Novartis Investigative Site
      • Padova, Italië
        • Novartis Investigative Site
      • Rome, Italië
        • Novartis Investigative Site
      • Scafati, Italië
        • Novartis Investigative Site
      • Torino, Italië
        • Novartis Investigative Site
  • Kalkoen
      • Ankara, Kalkoen
        • Novartis Investigative Site
      • Istanbul, Kalkoen
        • Novartis Investigative Site
      • Izmir, Kalkoen
        • Novartis Investigative Site
  • Nederland
      • Utrecht, Nederland
        • Novartis Investigative Site
  • Noorwegen
      • Oslo, Noorwegen
        • Novartis Investigative Site
  • Peru
      • Lima, Peru
        • Novartis Investigative Site
  • Polen
      • Warszawa, Polen
        • Novartis Investigative Site
  • Spanje
      • Barcelona, Spanje
        • Novartis Investigative Site
      • Madrid, Spanje
        • Novartis Investigative Site
      • Valencia, Spanje
        • Novartis Investigative Site
  • Verenigd Koninkrijk
      • Birmingham, Verenigd Koninkrijk
        • Novartis Investigative Site
      • Liverpool, Verenigd Koninkrijk
        • Novartis Investigative Site
      • London, Verenigd Koninkrijk
        • Novartis Investigative Site
      • Manchester, Verenigd Koninkrijk
        • Novartis Investigative Site
      • New Castle Upon Tyne, Verenigd Koninkrijk
        • Novartis Investigative Site
      • Norwich, Verenigd Koninkrijk
        • Novartis Investigative Site
      • Oxford, Verenigd Koninkrijk
        • Novartis Investigative Site
  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35233
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72202
        • Arkansas Children's Hospital Research Inst
    • California
      • Los Angeles, California, Verenigde Staten, 90027
        • Children's Hospital Los Angeles
    • District of Columbia
      • Washington, District of Columbia, Verenigde Staten, 20010
        • Children's National Medical Center
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
        • University of Chicago Medical Center
    • Kentucky
      • Louisville, Kentucky, Verenigde Staten, 40202
        • University of Louisville
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, Verenigde Staten, 02111
        • Tufts New England Medical Center-Dept. of Allergy
    • New Jersey
      • Livingston, New Jersey, Verenigde Staten, 07039
        • St. Barnabas Ambulatory Care Center
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45229
        • Children's Hospital Medical Center
      • Cinncinati, Ohio, Verenigde Staten, 45229
        • Children's Hospital/Neurology
      • Columbus, Ohio, Verenigde Staten, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97227
        • Legacy Emanuel Hospital
      • Portland, Oregon, Verenigde Staten, 97232
        • Legacy Emanual Research
    • Texas
      • Austin, Texas, Verenigde Staten, 78723
        • Specially For Children
  • Zuid-Afrika
      • Pretoria, Zuid-Afrika
        • Novartis Investigative Site
    • Durban
      • Berea, Durban, Zuid-Afrika
        • Novartis Investigative Site
      • Mayville, Durban, Zuid-Afrika
        • Novartis Investigative Site
  • Zweden
      • Stockholm, Zweden
        • Novartis Investigative Site
  • Zwitserland
      • Bern, Zwitserland
        • Novartis Investigative Site
      • Lausanne, Zwitserland
        • Novartis Investigative Site
      • Zurich, Zwitserland
        • 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

2 jaar tot 19 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Confirmed diagnosis of systemic juvenile idiopathic arthritis as per ILAR definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age:

    • Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following:
    • evanescent nonfixed erythematous rash,
    • generalized lymph node enlargement,
    • hepatomegaly and/ or splenomegaly,
    • serositis
  2. Parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's informed consent for ≥ 18 years of age
  3. Male and female patients aged ≥ 2 to < 20 years of age

  4. Active disease at the time of enrollment defined as follows:

    • At least 2 joints with active arthritis
    • Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day during the screening period within 1 week before first canakinumab/placebo dose
    • C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)
  5. Naïve to canakinumab
  6. Other protocol defined inclusion criteria may apply

Exclusion Criteria:

Patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study:

  1. Pregnant or nursing (lactating) female patients
  2. Female patients having reached sexual maturity unless their career, lifestyle, or sexual orientation precluded intercourse with a male partner and/or they were using an acceptable method of contraception
  3. History of hypersensitivity to study drug or to biologics.
  4. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within the last 6 months
  5. With active or recurrent bacterial, fungal or viral infection, including patients with evidence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C infection
  6. Other protocol defined 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: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Canakinumab
Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
Geneesmiddel: Canakinumab
Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL.
Andere namen:
  • ACZ885
Placebo-vergelijker: Placebo
Patients received a single dose matching placebo of canakinumab on day 1.
Geneesmiddel: Placebo
Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching canakinumab as a lyophilized cake. Each reconstitued vial provided 150mg of placebo per 1 mL.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
Tijdsspanne: Baseline, Day 15, Day 29
Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)
Baseline, Day 15, Day 29

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria
Tijdsspanne: Baseline, Day 15, Day 29
Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)
Baseline, Day 15, Day 29
Percentage of Patients Achieving the Adapted ACR Pediatric 70
Tijdsspanne: Baseline, Day 15, Day 29
Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 70% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)
Baseline, Day 15, Day 29
Percentage of Patients Achieving the Adapted ACR Pediatric 90
Tijdsspanne: Baseline, Day 15, Day 29
Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 90% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)
Baseline, Day 15, Day 29
Percentage of Patients Achieving the Adapted ACR Pediatric 100
Tijdsspanne: baseline, Day 15, Day 29
Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation
baseline, Day 15, Day 29
Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ)
Tijdsspanne: Baseline, Day 15
CHAQ assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty' (0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.
Baseline, Day 15
Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ
Tijdsspanne: Baseline, Day 29
CHAQ, assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.
Baseline, Day 29
Percentage of Patients Who Had Body Temperature ≤ 38°C
Tijdsspanne: Day 3
Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.
Day 3
Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50)
Tijdsspanne: Over 4 week study period (Baseline, Day 15, Day 29)
CHQ-PF50 measures HRQoL in children 5-18 years old from parent's perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.
Over 4 week study period (Baseline, Day 15, Day 29)
Change in Disability Score Over Time by Use of the CHAQ
Tijdsspanne: At 4 week study period
The disability dimension of CHAQ consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). Mixed linear model on change from baseline in CHAQ score included treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Negative change indicates improvement.
At 4 week study period

Medewerkers en onderzoekers

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

Sponsor

Novartis Pharmaceuticals

Medewerkers

International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Southwest Pediatric Nephrology Study Group

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

Nuttige links

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

1 juli 2009

Primaire voltooiing (Werkelijk)

1 december 2010

Studie voltooiing (Werkelijk)

1 januari 2011

Studieregistratiedata

Eerst ingediend

22 april 2009

Eerst ingediend dat voldeed aan de QC-criteria

22 april 2009

Eerst geplaatst (Schatting)

23 april 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 maart 2017

Laatste update ingediend die voldeed aan QC-criteria

28 februari 2017

Laatst geverifieerd

1 februari 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CACZ885G2305
  • EudraCT: 2008-005476-27

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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