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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 marzo 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

270

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 2 anni a 19 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Canakinumab
Droga: Canakinumab
Canakinumab

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Non--Responders Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Collaboratori

Pediatric Rheumatology International Trials Organization

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2009

Completamento primario (Effettivo)

1 dicembre 2014

Completamento dello studio (Effettivo)

1 dicembre 2014

Date di iscrizione allo studio

Primo inviato

29 aprile 2009

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2009

Primo Inserito (Stima)

30 aprile 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 marzo 2019

Ultimo verificato

1 luglio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CACZ885G2301E1
  • EudraCT: 2008-008008-42

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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