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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. Februar 2017 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

84

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien
        • Novartis Investigative Site
      • Capital Federal, Argentinien
        • Novartis Investigative Site
      • La Plata, Argentinien
        • 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
  • Deutschland
      • Bad Bamstedt, Deutschland
        • Novartis Investigative Site
      • Berlin, Deutschland
        • Novartis Investigative Site
      • Bremen, Deutschland
        • Novartis Investigative Site
      • Dresden, Deutschland
        • Novartis Investigative Site
      • Freiburg, Deutschland
        • Novartis Investigative Site
      • Garmisch-Partenkirch, Deutschland
        • Novartis Investigative Site
      • Geissen, Deutschland
        • Novartis Investigative Site
      • Hamburg, Deutschland
        • Novartis Investigative Site
      • Hannover, Deutschland
        • Novartis Investigative Site
      • Krefeld, Deutschland
        • Novartis Investigative Site
      • Mainz, Deutschland
        • Novartis Investigative Site
      • Muenster, Deutschland
        • Novartis Investigative Site
      • Saint Augustin, Deutschland
        • Novartis Investigative Site
      • Stuttgart, Deutschland
        • Novartis Investigative Site
      • Tubingen, Deutschland
        • Novartis Investigative Site
  • Dänemark
      • Arhus N, Dänemark
        • Novartis Investigative Site
  • Frankreich
      • Le Kremlin Bicetre, Frankreich
        • Novartis Investigative Site
      • Lyon, Frankreich
        • Novartis Investigative Site
      • Paris, Frankreich
        • Novartis Investigative Site
      • Strassbourg, Frankreich
        • Novartis Investigative Site
  • Griechenland
      • Thessaloniki, Griechenland
        • 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
  • 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
  • Niederlande
      • Utrecht, Niederlande
        • Novartis Investigative Site
  • Norwegen
      • Oslo, Norwegen
        • Novartis Investigative Site
  • Peru
      • Lima, Peru
        • Novartis Investigative Site
  • Polen
      • Warszawa, Polen
        • Novartis Investigative Site
  • Schweden
      • Stockholm, Schweden
        • 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
  • Südafrika
      • Pretoria, Südafrika
        • Novartis Investigative Site
    • Durban
      • Berea, Durban, Südafrika
        • Novartis Investigative Site
      • Mayville, Durban, Südafrika
        • Novartis Investigative Site
  • Truthahn
      • Ankara, Truthahn
        • Novartis Investigative Site
      • Istanbul, Truthahn
        • Novartis Investigative Site
      • Izmir, Truthahn
        • Novartis Investigative Site
  • Ungarn
      • Budapest, Ungarn
        • Novartis Investigative Site
  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35233
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, Vereinigte Staaten, 72202
        • Arkansas Children's Hospital Research Inst
    • California
      • Los Angeles, California, Vereinigte Staaten, 90027
        • Children's Hospital Los Angeles
    • District of Columbia
      • Washington, District of Columbia, Vereinigte Staaten, 20010
        • Children's National Medical Center
    • Illinois
      • Chicago, Illinois, Vereinigte Staaten, 60637
        • University of Chicago Medical Center
    • Kentucky
      • Louisville, Kentucky, Vereinigte Staaten, 40202
        • University of Louisville
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, Vereinigte Staaten, 02111
        • Tufts New England Medical Center-Dept. of Allergy
    • New Jersey
      • Livingston, New Jersey, Vereinigte Staaten, 07039
        • St. Barnabas Ambulatory Care Center
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45229
        • Children's Hospital Medical Center
      • Cinncinati, Ohio, Vereinigte Staaten, 45229
        • Children's Hospital/Neurology
      • Columbus, Ohio, Vereinigte Staaten, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97227
        • Legacy Emanuel Hospital
      • Portland, Oregon, Vereinigte Staaten, 97232
        • Legacy Emanual Research
    • Texas
      • Austin, Texas, Vereinigte Staaten, 78723
        • Specially For Children
  • Vereinigtes Königreich
      • Birmingham, Vereinigtes Königreich
        • Novartis Investigative Site
      • Liverpool, Vereinigtes Königreich
        • Novartis Investigative Site
      • London, Vereinigtes Königreich
        • Novartis Investigative Site
      • Manchester, Vereinigtes Königreich
        • Novartis Investigative Site
      • New Castle Upon Tyne, Vereinigtes Königreich
        • Novartis Investigative Site
      • Norwich, Vereinigtes Königreich
        • Novartis Investigative Site
      • Oxford, Vereinigtes Königreich
        • Novartis Investigative Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Jahre bis 19 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: 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-Komparator: Placebo
Patients received a single dose matching placebo of canakinumab on day 1.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Novartis Pharmaceuticals

Mitarbeiter

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2009

Primärer Abschluss (Tatsächlich)

1. Dezember 2010

Studienabschluss (Tatsächlich)

1. Januar 2011

Studienanmeldedaten

Zuerst eingereicht

22. April 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. April 2009

Zuerst gepostet (Schätzen)

23. April 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. März 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Februar 2017

Zuletzt verifiziert

1. Februar 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CACZ885G2305
  • EudraCT: 2008-005476-27

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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