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An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever. (β-SPECIFIC 3)

19 marca 2019 zaktualizowane przez: Novartis Pharmaceuticals

An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever

This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

270

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Argentyna
    • Buenos Aires
      • Caba, Buenos Aires, Argentyna, C1270AAN
        • Novartis Investigative Site
  • Austria
      • Vienna, Austria, A-1090
        • Novartis Investigative Site
  • Belgia
      • Bruxelles, Belgia, 1200
        • Novartis Investigative Site
      • Gent, Belgia, 9000
        • Novartis Investigative Site
      • Laeken, Belgia, 1020
        • Novartis Investigative Site
      • Leuven, Belgia, 3000
        • Novartis Investigative Site
  • Brazylia
    • PR
      • Curitiba, PR, Brazylia, 80060-900
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brazylia, 20551-030
        • Novartis Investigative Site
      • Rio de Janeiro, RJ, Brazylia, 21941-912
        • Novartis Investigative Site
    • SP
      • São Paulo, SP, Brazylia, 04023-900
        • Novartis Investigative Site
  • Federacja Rosyjska
      • Moscow, Federacja Rosyjska, 115522
        • Novartis Investigative Site
      • Moscow, Federacja Rosyjska, 119991
        • Novartis Investigative Site
      • Saint-Petersburg, Federacja Rosyjska, 194100
        • Novartis Investigative Site
  • Francja
      • Le Kremlin Bicetre, Francja, 94275
        • Novartis Investigative Site
      • Lyon, Francja, 69677
        • Novartis Investigative Site
      • Paris cedex 15, Francja, 75015
        • Novartis Investigative Site
      • Strasbourg, Francja, 67098
        • Novartis Investigative Site
  • Grecja
      • Goudi- Athens, Grecja, 115 27
        • Novartis Investigative Site
    • GR
      • Ampelokipi, GR, Grecja, 115 27
        • Novartis Investigative Site
      • Thessaloniki, GR, Grecja, 546 39
        • Novartis Investigative Site
  • Hiszpania
      • Madrid, Hiszpania, 28034
        • Novartis Investigative Site
      • Madrid, Hiszpania, 28009
        • Novartis Investigative Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Hiszpania, 08950
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Hiszpania, 46026
        • Novartis Investigative Site
  • Holandia
      • Utrecht, Holandia, 3584 EA
        • Novartis Investigative Site
  • Indyk
      • Ankara, Indyk, 06100
        • Novartis Investigative Site
      • Balcova / Izmir, Indyk, 35340
        • Novartis Investigative Site
      • Fatih / Istanbul, Indyk, 34098
        • Novartis Investigative Site
      • Istanbul, Indyk, 34722
        • Novartis Investigative Site
  • Izrael
      • Haifa, Izrael, 31096
        • Novartis Investigative Site
      • Kfar-Sava, Izrael, 4428164
        • Novartis Investigative Site
      • Petach-Tikva, Izrael, 49202
        • Novartis Investigative Site
      • Ramat Gan, Izrael, 5266202
        • Novartis Investigative Site
      • Rehovot, Izrael, 76100
        • Novartis Investigative Site
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Kanada, M5G 1X8
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Kanada, H3T 1C5
        • Novartis Investigative Site
  • Niemcy
      • Bad Bramstedt, Niemcy, 24576
        • Novartis Investigative Site
      • Berlin, Niemcy, 13125
        • Novartis Investigative Site
      • Berlin, Niemcy, 13353
        • Novartis Investigative Site
      • Freiburg, Niemcy, 79106
        • Novartis Investigative Site
      • Garmisch-Partenkirchen, Niemcy, 82467
        • Novartis Investigative Site
      • Gießen, Niemcy, 35392
        • Novartis Investigative Site
      • Hamburg, Niemcy, 20246
        • Novartis Investigative Site
      • Hamburg, Niemcy, 22081
        • Novartis Investigative Site
      • Hannover, Niemcy, 30625
        • Novartis Investigative Site
      • Heidelberg, Niemcy, 69120
        • Novartis Investigative Site
      • Muenster, Niemcy, 48149
        • Novartis Investigative Site
      • Saint Augustin, Niemcy, 53757
        • Novartis Investigative Site
      • Tübingen, Niemcy, 72076
        • Novartis Investigative Site
  • Peru
    • Lima
      • Breña, Lima, Peru, 05
        • Novartis Investigative Site
  • Polska
      • Warszawa, Polska, 02-637
        • Novartis Investigative Site
  • Stany Zjednoczone
    • California
      • Los Angeles, California, Stany Zjednoczone, 90027
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40202
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02111
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, Stany Zjednoczone, 45229
        • Novartis Investigative Site
      • Columbus, Ohio, Stany Zjednoczone, 43205
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97232
        • Novartis Investigative Site
  • Szwajcaria
      • Lausanne, Szwajcaria, 1011
        • Novartis Investigative Site
  • Szwecja
      • Stockholm, Szwecja, 171 76
        • Novartis Investigative Site
  • Węgry
      • Budapest, Węgry, 1094
        • Novartis Investigative Site
  • Włochy
      • Napoli, Włochy, 80131
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Włochy, 50132
        • Novartis Investigative Site
    • GE
      • Genova, GE, Włochy, 16147
        • Novartis Investigative Site
    • MI
      • Milano, MI, Włochy, 20122
        • Novartis Investigative Site
      • Milano, MI, Włochy, 20100
        • Novartis Investigative Site
  • Zjednoczone Królestwo
      • Bath, Zjednoczone Królestwo, BS2 8BJ
        • Novartis Investigative Site
      • Birmingham, Zjednoczone Królestwo, B4 6NH
        • Novartis Investigative Site
      • Liverpool, Zjednoczone Królestwo, L12 2AP
        • Novartis Investigative Site
      • London, Zjednoczone Królestwo, WC1N 1EH
        • Novartis Investigative Site
      • Manchester, Zjednoczone Królestwo, M9 2AA
        • Novartis Investigative Site
      • Newcastle Upon Tyme, Zjednoczone Królestwo, NE4 4LP
        • Novartis Investigative Site
      • Oxford, Zjednoczone Królestwo, OX3 7LD
        • Novartis Investigative Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

2 lata do 19 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion criteria:

  • Patients from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric 30 response 15 days after their initial dose of canakinumab but clinically deteriorated afterwards or a minimum ACR Pediatric 30 response was not maintained after Day 15 and intervention is deemed necessary by the investigator, or Patients in study CACZ885G2301 who are not eligible to enter Part II (withdrawal part) because they were not able to meet the corticosteroid entry criteria , or Responder patients in Part I or Part II who had not flared when CACZ885G2301 was stopped, or CACZ885G2301 patients who were responders in Part I but experienced a flare in Part II.

  • Treatment-naïve patients need to meet the following criteria:

    • 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
    • Male and female patients aged ≥ 2 to < 20 years of age

    • Active disease at the time of enrollment defined as having 2 or more of the following:

      • Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day during the screening period and within 1 week before first canakinumab dose
      • At least 2 joints with active arthritis
      • AND C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L) Rash Serositis Lymphadenopathy Hepatosplenomegaly
    • Naïve to canakinumab

Other protocol-defined inclusion criteria may apply

Exclusion criteria:

  • History of allergy or hypersensitivity to study drug
  • With active or recurrent bacterial, fungal or viral infections at time of enrollment

Other protocol inclusion/exclusion criteria may apply

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Canakinumab
Lek: Kanakinumab
Kanakinumab

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE
Ramy czasowe: From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participants or require medical or surgical intervention to prevent one of the aforementioned outcomes. Treatment related AEs or SAEs were defined as AEs or SAEs that were suspected to be related to study treatment as per investigator.
From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
Number of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study
Ramy czasowe: From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system.
From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
Number of Participants With Clinically Significant Local Injection Site Reactions During the Study
Ramy czasowe: From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
Local injection site tolerability was assessed on the injection site. Each participant was classified into one of the following four categories: 1. no tolerability reactions at any time during the study, 2. mild reaction observed on at least one occasion but no moderate or severe reactions. 3. moderate reaction observed on at least one occasion but no severe reaction. 4. severe reaction observed on at least one occasion.
From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
Percentage of Participants Previously Treated With Anakinra Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 1-100 millimeter (mm) visual analog scale (VAS); 2. Participants Global Assessment on a 1-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of C-reactive protein (CRP) and 7. Absence of intermittent fever due to severe juvenile idiopathic arthritis (SJIA) during the preceding week. Response was defined as more than or equal to (≥) 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature less than or equal to (≤) 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Percentage of Participants Previously Treated With Tocilizumab Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Percentage of Participants Previously Treated With Other Biologics Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38 °C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Non--Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of -CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever (i.e. body temperature ≤ 38°C) in the preceding week (variable 7) and with no more than one variable 1 to 6, worsening by more than 30%.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Percentage of Participants With Minimum Adapted ACR Pediatric ≥ 30 at Baseline Who Achieved Minimum Response of ACR Pediatric 30/50/70/90/100 at Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Adapted ACR Paediatric 30/50/70/90 or 100 was assessed based on following 7 variables: 1.Physician's Global Assessment on a 0-100 mm VAS; 2. Participants Global Assessment on a 0-100 mm VAS; 3. Functional ability; 4. Joints count with active arthritis; 5. Joints count with limitation of motion; 6. Laboratory measure of CRP and 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as ≥ 30%/50%/70%/90% or 100% improvement in at least 3 of the response variables 1 to 6, no intermittent fever in the preceding week (variable 7) and with no more than one variable 1 to 6 worsening by more than 30%. For minimum adapted ACR paediatric scores, the last measurement recorded from the participant's previous study was considered baseline for the current study.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Percentage of Participants Able to Taper Oral Steroid Use or Reached Steroid Free Regimen
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Steroid tapering with oral steroids was allowed if the participant achieved an adapted ACR Paediatric 50 response and had no fever. A participant was considered to have tapered steroids successfully, if the steroid dose was reduced from baseline and the participant did not flare and maintained a minimum adapted ACR Paediatric 30 at the last measurement. A participant was considered to have unsuccessfully tapered steroids if the steroid dose was reduced during the study but dose at last assessment was equal to or greater than dose at baseline or; if steroid dose was reduced but the participant did not maintain a minimum adapted ACR Paediatric 30 at the last measurement.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Number of Participants Who Reduced Their Canakinumab Dose to 2 mg/kg
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
The canakinumab dose could be reduced from 4 mg/kg to 2 mg/kg in participants who were steroid-free, if requested by the treating physician and agreed by the sponsor. For treatment naive participants , dose reduction was allowed after the participant had received 6 months treatment with canakinumab.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Percentage of Participants With Clinical Remission
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Clinical remission was defined as at least 6 months of inactive disease or at least 12 months of inactive disease on medication during the extension period. Participants with inactive disease for at least 6 months, but had loss of inactive disease before 12 months were also determined.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Change From Baseline in Disability, Overall Well-Being and Pain Intensity Scores Based on Child Health Assessment Questionnaire (CHAQ) to Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
The CHAQ was used to assess physical ability, overall well- being and pain intensity experienced by participants. The CHAQ (disability and well-being) dimension consisted of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other "activities". Participants were graded for the response in four categories, ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Participant's pain intensity was assessed by parents and adult participants (18-20 years old) on a VAS scale of 0-100 mm (0 mm: no pain to 100: very severe pain). Change from baseline was calculated by using the formula = (post baseline value - baseline value). For both scales, lower scores indicate increased functional ability.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Change From Baseline in Health-Related Quality of Life (HRQoL) Over Time Based on Child Health Questionnaire- Parent Form (CHQ-PF50) to Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
The Child Health Questionnaire - Parent Form (CHQ-PF50) instrument was used to measure HRQoL aged 5 to 18 years from a parent's perspective. This 14 concept questionnaire measured physical and psychosocial health of the participants on following points: physical functioning, role/social emotional, role/social behavior, role/social physical, bodily pain, general behavior, mental health, self-esteem, general health perception, change in health, parental impact - emotional, parental impact - time, family activities, and family cohesion. Total score ranged from 1-100. Increase in score represented improvement in overall well being of participants. Change from baseline was calculated by using the formula = (post baseline value - baseline value).
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Change From Baseline in EuroQual 5 -Dimension Health Status Questionnaire (EQ-5D) Utility Index and Health State Assessment Scores [EQ Visual Analog Scale (EQ-VAS)] to Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier

EQ-5D HRQoL tool was used for participants above 12 years and EQ-5D proxy for 8-11 years. EQ-5D index scores range from -0.11 (worst possible health, worse than dead), to 0 (dead) to 1 (perfect health). Utility based EQ-5D questionnaire provides generic measure of health for clinical and economic appraisal based on 2 parts: EQ-5D descriptive system - 5 dimensions each with 3 levels (1:no, 2:moderate, 3:severe problem) on: mobility (1=0, 2=0.069, 3=0.314), self-care (1=0, 2=0.104, 3=0.214), usual activities (1=0, 2=0.036, 3=0.094), pain/discomfort (1=0, 2=0, 3=0.386) and anxiety/depression (1=0, 2=0.071, 3=0.2). EQ-5D Total score= 1-0.081-(score of level 2 in present)-0.269 (if at least one of level 3 presents). EQ-5D total score: 1=high quality of life; -0.59 worst quality of life; and EQ-VAS - record participant's self-rated health on vertical, visual analog scale as '100=Best and 0=Worst imaginable health state'.

Positive change from baseline score indicated improved health status.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Change From Baseline in Pediatric Daytime Sleepiness Scale (PDSS) Score to Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Sleep patterns in children and adolescents aged between 11 and 15 years were determined using PDSS instrument to evaluate whether canakinumab helps in reducing sleepiness in children with SJIA. Participants were assessed on 8 items of PDSS, on a scale of 0 to 4 (0 - never, 1 - seldom, 2- sometimes, 3 - frequently and 4 - always). The sum of all the items was reported as total score with a range of 0-32. Change from baseline was calculated by using the formula = (post baseline value - baseline value). A positive change from baseline score indicated improvement.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Change From Baseline in Growth Velocity Parameter for Height to Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Growth velocity parameter height percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Percentage of Participants With Inactive Disease
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Inactive disease was defined as no joints with active arthritis; no fever (body temperature ≤ 38 degree Celsius); no rheumatoid rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to SJIA; normal CRP, and a rating of no disease activity on the Physician's Global Assessment of disease activity (with a best possible score ≤10 mm on the VAS).
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Change From Baseline in Growth Velocity Parameters to Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Growth velocity parameter weight percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Change From Baseline in Growth Velocity Parameter for BMI to Last Assessment of Study
Ramy czasowe: Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
Growth velocity parameter BMI percentile was determined. Percentile was based on the growth charts smoothed percentile curve released by Centers for Disease control and prevention (CDC) in 2000, by sex and age.
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Pharmaceuticals

Współpracownicy

Pediatric Rheumatology International Trials Organization

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 września 2009

Zakończenie podstawowe (Rzeczywisty)

1 grudnia 2014

Ukończenie studiów (Rzeczywisty)

1 grudnia 2014

Daty rejestracji na studia

Pierwszy przesłany

29 kwietnia 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 kwietnia 2009

Pierwszy wysłany (Oszacować)

30 kwietnia 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 marca 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 marca 2019

Ostatnia weryfikacja

1 lipca 2018

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CACZ885G2301E1
  • EudraCT: 2008-008008-42

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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