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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 de febrero de 2017 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

84

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Bad Bamstedt, Alemania
        • Novartis Investigative Site
      • Berlin, Alemania
        • Novartis Investigative Site
      • Bremen, Alemania
        • Novartis Investigative Site
      • Dresden, Alemania
        • Novartis Investigative Site
      • Freiburg, Alemania
        • Novartis Investigative Site
      • Garmisch-Partenkirch, Alemania
        • Novartis Investigative Site
      • Geissen, Alemania
        • Novartis Investigative Site
      • Hamburg, Alemania
        • Novartis Investigative Site
      • Hannover, Alemania
        • Novartis Investigative Site
      • Krefeld, Alemania
        • Novartis Investigative Site
      • Mainz, Alemania
        • Novartis Investigative Site
      • Muenster, Alemania
        • Novartis Investigative Site
      • Saint Augustin, Alemania
        • Novartis Investigative Site
      • Stuttgart, Alemania
        • Novartis Investigative Site
      • Tubingen, Alemania
        • Novartis Investigative Site
  • Argentina
      • Buenos Aires, Argentina
        • Novartis Investigative Site
      • Capital Federal, Argentina
        • Novartis Investigative Site
      • La Plata, Argentina
        • Novartis Investigative Site
  • Brasil
      • Curitiba, Brasil
        • Novartis Investigative Site
      • Porto Alegre, Brasil
        • Novartis Investigative Site
      • Rio de Janeiro, Brasil
        • Novartis Investigative Site
      • Sao Paulo, Brasil
        • Novartis Investigative Site
  • Bélgica
      • Bruxelles, Bélgica
        • Novartis Investigative Site
      • Gent, Bélgica
        • Novartis Investigative Site
      • Laeken, Bélgica
        • Novartis Investigative Site
      • Leuven, Bélgica
        • Novartis Investigative Site
  • Canadá
      • Calgary, Canadá
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canadá
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canadá
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canadá
        • Novartis Investigative Site
  • Dinamarca
      • Arhus N, Dinamarca
        • Novartis Investigative Site
  • España
      • Barcelona, España
        • Novartis Investigative Site
      • Madrid, España
        • Novartis Investigative Site
      • Valencia, España
        • Novartis Investigative Site
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • University of Alabama at Birmingham
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72202
        • Arkansas Children's Hospital Research Inst
    • California
      • Los Angeles, California, Estados Unidos, 90027
        • Children's Hospital Los Angeles
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20010
        • Children's National Medical Center
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • University of Chicago Medical Center
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40202
        • University of Louisville
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, Estados Unidos, 02111
        • Tufts New England Medical Center-Dept. of Allergy
    • New Jersey
      • Livingston, New Jersey, Estados Unidos, 07039
        • St. Barnabas Ambulatory Care Center
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Children's Hospital Medical Center
      • Cinncinati, Ohio, Estados Unidos, 45229
        • Children's Hospital/Neurology
      • Columbus, Ohio, Estados Unidos, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, Estados Unidos, 97227
        • Legacy Emanuel Hospital
      • Portland, Oregon, Estados Unidos, 97232
        • Legacy Emanual Research
    • Texas
      • Austin, Texas, Estados Unidos, 78723
        • Specially For Children
  • Francia
      • Le Kremlin Bicetre, Francia
        • Novartis Investigative Site
      • Lyon, Francia
        • Novartis Investigative Site
      • Paris, Francia
        • Novartis Investigative Site
      • Strassbourg, Francia
        • Novartis Investigative Site
  • Grecia
      • Thessaloniki, Grecia
        • Novartis Investigative Site
  • Hungría
      • Budapest, Hungría
        • 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
  • Italia
      • Bologna, Italia
        • Novartis Investigative Site
      • Firenze, Italia
        • Novartis Investigative Site
      • Genova, Italia
        • Novartis Investigative Site
      • Milano, Italia
        • Novartis Investigative Site
      • Napoli, Italia
        • Novartis Investigative Site
      • Padova, Italia
        • Novartis Investigative Site
      • Rome, Italia
        • Novartis Investigative Site
      • Scafati, Italia
        • Novartis Investigative Site
      • Torino, Italia
        • Novartis Investigative Site
  • Noruega
      • Oslo, Noruega
        • Novartis Investigative Site
  • Pavo
      • Ankara, Pavo
        • Novartis Investigative Site
      • Istanbul, Pavo
        • Novartis Investigative Site
      • Izmir, Pavo
        • Novartis Investigative Site
  • Países Bajos
      • Utrecht, Países Bajos
        • Novartis Investigative Site
  • Perú
      • Lima, Perú
        • Novartis Investigative Site
  • Polonia
      • Warszawa, Polonia
        • Novartis Investigative Site
  • Reino Unido
      • Birmingham, Reino Unido
        • Novartis Investigative Site
      • Liverpool, Reino Unido
        • Novartis Investigative Site
      • London, Reino Unido
        • Novartis Investigative Site
      • Manchester, Reino Unido
        • Novartis Investigative Site
      • New Castle Upon Tyne, Reino Unido
        • Novartis Investigative Site
      • Norwich, Reino Unido
        • Novartis Investigative Site
      • Oxford, Reino Unido
        • Novartis Investigative Site
  • Sudáfrica
      • Pretoria, Sudáfrica
        • Novartis Investigative Site
    • Durban
      • Berea, Durban, Sudáfrica
        • Novartis Investigative Site
      • Mayville, Durban, Sudáfrica
        • Novartis Investigative Site
  • Suecia
      • Stockholm, Suecia
        • Novartis Investigative Site
  • Suiza
      • Bern, Suiza
        • Novartis Investigative Site
      • Lausanne, Suiza
        • Novartis Investigative Site
      • Zurich, Suiza
        • Novartis Investigative Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

2 años a 19 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Droga: 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.
Otros nombres:
  • ACZ885
Comparador de placebos: Placebo
Patients received a single dose matching placebo of canakinumab on day 1.
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Colaboradores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de julio de 2009

Finalización primaria (Actual)

1 de diciembre de 2010

Finalización del estudio (Actual)

1 de enero de 2011

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2009

Primero enviado que cumplió con los criterios de control de calidad

22 de abril de 2009

Publicado por primera vez (Estimar)

23 de abril de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de marzo de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

28 de febrero de 2017

Última verificación

1 de febrero de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CACZ885G2305
  • EudraCT: 2008-005476-27

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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