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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 mars 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

270

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
      • Caba, Buenos Aires, Argentina, C1270AAN
        • Novartis Investigative Site
  • Belgien
      • Bruxelles, Belgien, 1200
        • Novartis Investigative Site
      • Gent, Belgien, 9000
        • Novartis Investigative Site
      • Laeken, Belgien, 1020
        • Novartis Investigative Site
      • Leuven, Belgien, 3000
        • Novartis Investigative Site
  • Brasilien
    • PR
      • Curitiba, PR, Brasilien, 80060-900
        • Novartis Investigative Site
    • RJ
      • Rio de Janeiro, RJ, Brasilien, 20551-030
        • Novartis Investigative Site
      • Rio de Janeiro, RJ, Brasilien, 21941-912
        • Novartis Investigative Site
    • SP
      • São Paulo, SP, Brasilien, 04023-900
        • Novartis Investigative Site
  • Frankrike
      • Le Kremlin Bicetre, Frankrike, 94275
        • Novartis Investigative Site
      • Lyon, Frankrike, 69677
        • Novartis Investigative Site
      • Paris cedex 15, Frankrike, 75015
        • Novartis Investigative Site
      • Strasbourg, Frankrike, 67098
        • Novartis Investigative Site
  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90027
        • Novartis Investigative Site
    • Kentucky
      • Louisville, Kentucky, Förenta staterna, 40202
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02111
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45229
        • Novartis Investigative Site
      • Columbus, Ohio, Förenta staterna, 43205
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, Förenta staterna, 97232
        • Novartis Investigative Site
  • Grekland
      • Goudi- Athens, Grekland, 115 27
        • Novartis Investigative Site
    • GR
      • Ampelokipi, GR, Grekland, 115 27
        • Novartis Investigative Site
      • Thessaloniki, GR, Grekland, 546 39
        • Novartis Investigative Site
  • Israel
      • Haifa, Israel, 31096
        • Novartis Investigative Site
      • Kfar-Sava, Israel, 4428164
        • Novartis Investigative Site
      • Petach-Tikva, Israel, 49202
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5266202
        • Novartis Investigative Site
      • Rehovot, Israel, 76100
        • Novartis Investigative Site
  • Italien
      • Napoli, Italien, 80131
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italien, 50132
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italien, 16147
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italien, 20122
        • Novartis Investigative Site
      • Milano, MI, Italien, 20100
        • Novartis Investigative Site
  • Kalkon
      • Ankara, Kalkon, 06100
        • Novartis Investigative Site
      • Balcova / Izmir, Kalkon, 35340
        • Novartis Investigative Site
      • Fatih / Istanbul, Kalkon, 34098
        • Novartis Investigative Site
      • Istanbul, Kalkon, 34722
        • 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
  • Nederländerna
      • Utrecht, Nederländerna, 3584 EA
        • Novartis Investigative Site
  • Peru
    • Lima
      • Breña, Lima, Peru, 05
        • Novartis Investigative Site
  • Polen
      • Warszawa, Polen, 02-637
        • Novartis Investigative Site
  • Ryska Federationen
      • Moscow, Ryska Federationen, 115522
        • Novartis Investigative Site
      • Moscow, Ryska Federationen, 119991
        • Novartis Investigative Site
      • Saint-Petersburg, Ryska Federationen, 194100
        • Novartis Investigative Site
  • Schweiz
      • Lausanne, Schweiz, 1011
        • Novartis Investigative Site
  • Spanien
      • Madrid, Spanien, 28034
        • Novartis Investigative Site
      • Madrid, Spanien, 28009
        • Novartis Investigative Site
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spanien, 08950
        • Novartis Investigative Site
    • Comunidad Valenciana
      • Valencia, Comunidad Valenciana, Spanien, 46026
        • Novartis Investigative Site
  • Storbritannien
      • Bath, Storbritannien, BS2 8BJ
        • Novartis Investigative Site
      • Birmingham, Storbritannien, B4 6NH
        • Novartis Investigative Site
      • Liverpool, Storbritannien, L12 2AP
        • Novartis Investigative Site
      • London, Storbritannien, WC1N 1EH
        • Novartis Investigative Site
      • Manchester, Storbritannien, M9 2AA
        • Novartis Investigative Site
      • Newcastle Upon Tyme, Storbritannien, NE4 4LP
        • Novartis Investigative Site
      • Oxford, Storbritannien, OX3 7LD
        • Novartis Investigative Site
  • Sverige
      • Stockholm, Sverige, 171 76
        • Novartis Investigative Site
  • Tyskland
      • Bad Bramstedt, Tyskland, 24576
        • Novartis Investigative Site
      • Berlin, Tyskland, 13125
        • Novartis Investigative Site
      • Berlin, Tyskland, 13353
        • Novartis Investigative Site
      • Freiburg, Tyskland, 79106
        • Novartis Investigative Site
      • Garmisch-Partenkirchen, Tyskland, 82467
        • Novartis Investigative Site
      • Gießen, Tyskland, 35392
        • Novartis Investigative Site
      • Hamburg, Tyskland, 20246
        • Novartis Investigative Site
      • Hamburg, Tyskland, 22081
        • Novartis Investigative Site
      • Hannover, Tyskland, 30625
        • Novartis Investigative Site
      • Heidelberg, Tyskland, 69120
        • Novartis Investigative Site
      • Muenster, Tyskland, 48149
        • Novartis Investigative Site
      • Saint Augustin, Tyskland, 53757
        • Novartis Investigative Site
      • Tübingen, Tyskland, 72076
        • Novartis Investigative Site
  • Ungern
      • Budapest, Ungern, 1094
        • Novartis Investigative Site
  • Österrike
      • Vienna, Österrike, A-1090
        • 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:

  • 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

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: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Canakinumab
Läkemedel: Canakinumab
Canakinumab

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Non--Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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

Sponsor

Novartis Pharmaceuticals

Samarbetspartners

Pediatric Rheumatology International Trials Organization

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 september 2009

Primärt slutförande (Faktisk)

1 december 2014

Avslutad studie (Faktisk)

1 december 2014

Studieregistreringsdatum

Först inskickad

29 april 2009

Först inskickad som uppfyllde QC-kriterierna

29 april 2009

Första postat (Uppskatta)

30 april 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 mars 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 mars 2019

Senast verifierad

1 juli 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CACZ885G2301E1
  • EudraCT: 2008-008008-42

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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