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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

84

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Buenos Aires, Argentina
        • Novartis Investigative Site
      • Capital Federal, Argentina
        • Novartis Investigative Site
      • La Plata, Argentina
        • Novartis Investigative Site
  • Belgien
      • Bruxelles, Belgien
        • Novartis Investigative Site
      • Gent, Belgien
        • Novartis Investigative Site
      • Laeken, Belgien
        • Novartis Investigative Site
      • Leuven, Belgien
        • Novartis Investigative Site
  • Brasilien
      • Curitiba, Brasilien
        • Novartis Investigative Site
      • Porto Alegre, Brasilien
        • Novartis Investigative Site
      • Rio de Janeiro, Brasilien
        • Novartis Investigative Site
      • Sao Paulo, Brasilien
        • Novartis Investigative Site
  • Danmark
      • Arhus N, Danmark
        • Novartis Investigative Site
  • Frankrike
      • Le Kremlin Bicetre, Frankrike
        • Novartis Investigative Site
      • Lyon, Frankrike
        • Novartis Investigative Site
      • Paris, Frankrike
        • Novartis Investigative Site
      • Strassbourg, Frankrike
        • Novartis Investigative Site
  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35233
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72202
        • Arkansas Children's Hospital Research Inst
    • California
      • Los Angeles, California, Förenta staterna, 90027
        • Children's Hospital Los Angeles
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20010
        • Children's National Medical Center
    • Illinois
      • Chicago, Illinois, Förenta staterna, 60637
        • University of Chicago Medical Center
    • Kentucky
      • Louisville, Kentucky, Förenta staterna, 40202
        • University of Louisville
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, Förenta staterna, 02111
        • Tufts New England Medical Center-Dept. of Allergy
    • New Jersey
      • Livingston, New Jersey, Förenta staterna, 07039
        • St. Barnabas Ambulatory Care Center
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45229
        • Children's Hospital Medical Center
      • Cinncinati, Ohio, Förenta staterna, 45229
        • Children's Hospital/Neurology
      • Columbus, Ohio, Förenta staterna, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, Förenta staterna, 97227
        • Legacy Emanuel Hospital
      • Portland, Oregon, Förenta staterna, 97232
        • Legacy Emanual Research
    • Texas
      • Austin, Texas, Förenta staterna, 78723
        • Specially For Children
  • Grekland
      • Thessaloniki, Grekland
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel
        • Novartis Investigative Site
      • Kfar Saba, Israel
        • Novartis Investigative Site
      • Petach-Tikva, Israel
        • Novartis Investigative Site
      • Ramat Gan, Israel
        • Novartis Investigative Site
      • Rehovot, Israel
        • Novartis Investigative Site
  • Italien
      • Bologna, Italien
        • Novartis Investigative Site
      • Firenze, Italien
        • Novartis Investigative Site
      • Genova, Italien
        • Novartis Investigative Site
      • Milano, Italien
        • Novartis Investigative Site
      • Napoli, Italien
        • Novartis Investigative Site
      • Padova, Italien
        • Novartis Investigative Site
      • Rome, Italien
        • Novartis Investigative Site
      • Scafati, Italien
        • Novartis Investigative Site
      • Torino, Italien
        • Novartis Investigative Site
  • Kalkon
      • Ankara, Kalkon
        • Novartis Investigative Site
      • Istanbul, Kalkon
        • Novartis Investigative Site
      • Izmir, Kalkon
        • Novartis Investigative Site
  • Kanada
      • Calgary, Kanada
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Kanada
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Kanada
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Kanada
        • Novartis Investigative Site
  • Nederländerna
      • Utrecht, Nederländerna
        • Novartis Investigative Site
  • Norge
      • Oslo, Norge
        • Novartis Investigative Site
  • Peru
      • Lima, Peru
        • Novartis Investigative Site
  • Polen
      • Warszawa, Polen
        • Novartis Investigative Site
  • Schweiz
      • Bern, Schweiz
        • Novartis Investigative Site
      • Lausanne, Schweiz
        • Novartis Investigative Site
      • Zurich, Schweiz
        • Novartis Investigative Site
  • Spanien
      • Barcelona, Spanien
        • Novartis Investigative Site
      • Madrid, Spanien
        • Novartis Investigative Site
      • Valencia, Spanien
        • Novartis Investigative Site
  • Storbritannien
      • Birmingham, Storbritannien
        • Novartis Investigative Site
      • Liverpool, Storbritannien
        • Novartis Investigative Site
      • London, Storbritannien
        • Novartis Investigative Site
      • Manchester, Storbritannien
        • Novartis Investigative Site
      • New Castle Upon Tyne, Storbritannien
        • Novartis Investigative Site
      • Norwich, Storbritannien
        • Novartis Investigative Site
      • Oxford, Storbritannien
        • Novartis Investigative Site
  • Sverige
      • Stockholm, Sverige
        • Novartis Investigative Site
  • Sydafrika
      • Pretoria, Sydafrika
        • Novartis Investigative Site
    • Durban
      • Berea, Durban, Sydafrika
        • Novartis Investigative Site
      • Mayville, Durban, Sydafrika
        • Novartis Investigative Site
  • Tyskland
      • Bad Bamstedt, Tyskland
        • Novartis Investigative Site
      • Berlin, Tyskland
        • Novartis Investigative Site
      • Bremen, Tyskland
        • Novartis Investigative Site
      • Dresden, Tyskland
        • Novartis Investigative Site
      • Freiburg, Tyskland
        • Novartis Investigative Site
      • Garmisch-Partenkirch, Tyskland
        • Novartis Investigative Site
      • Geissen, Tyskland
        • Novartis Investigative Site
      • Hamburg, Tyskland
        • Novartis Investigative Site
      • Hannover, Tyskland
        • Novartis Investigative Site
      • Krefeld, Tyskland
        • Novartis Investigative Site
      • Mainz, Tyskland
        • Novartis Investigative Site
      • Muenster, Tyskland
        • Novartis Investigative Site
      • Saint Augustin, Tyskland
        • Novartis Investigative Site
      • Stuttgart, Tyskland
        • Novartis Investigative Site
      • Tubingen, Tyskland
        • Novartis Investigative Site
  • Ungern
      • Budapest, Ungern
        • Novartis Investigative Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

2 år till 19 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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.
Andra namn:
  • ACZ885
Placebo-jämförare: Placebo
Patients received a single dose matching placebo of canakinumab on day 1.
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Samarbetspartners

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2009

Primärt slutförande (Faktisk)

1 december 2010

Avslutad studie (Faktisk)

1 januari 2011

Studieregistreringsdatum

Först inskickad

22 april 2009

Först inskickad som uppfyllde QC-kriterierna

22 april 2009

Första postat (Uppskatta)

23 april 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 februari 2017

Senast verifierad

1 februari 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CACZ885G2305
  • EudraCT: 2008-005476-27

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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