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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2008-005476-27 |
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recommendation by Data Monitoring Committee
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| Name | Class |
|---|---|
| International Maternal Pediatric Adolescent AIDS Clinical Trials Group | NETWORK |
| Southwest Pediatric Nephrology Study Group | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canakinumab | Experimental | 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. |
|
| Placebo | Placebo Comparator | Patients received a single dose matching placebo of canakinumab on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canakinumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria | 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) |
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Inclusion 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:
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
Male and female patients aged ≥ 2 to < 20 years of age
Active disease at the time of enrollment defined as follows:
Naïve to canakinumab
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:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Arkansas Children's Hospital Research Inst |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30269054 | Derived | Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat NM, Horneff G, Kasapcopur O, Schneider R, Anton J, Barash J, Berner R, Corona F, Cuttica R, Fouillet-Desjonqueres M, Fischbach M, Foster HE, Foell D, Radominski SC, Ramanan AV, Trauzeddel R, Unsal E, Levy J, Vritzali E, Martini A, Lovell DJ; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials. Ann Rheum Dis. 2018 Dec;77(12):1710-1719. doi: 10.1136/annrheumdis-2018-213150. Epub 2018 Sep 29. | |
| 28115015 |
| Label | URL |
|---|---|
| Click here for more information about this study | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | 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. |
|
| Baseline, Day 15, Day 29 |
| Percentage of Patients Achieving the Adapted ACR Pediatric 70 | 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 | 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 | 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) | 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 | 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 | 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) | 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 | 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 |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Tufts New England Medical Center-Dept. of Allergy | Boston | Massachusetts | 02111 | United States |
| St. Barnabas Ambulatory Care Center | Livingston | New Jersey | 07039 | United States |
| Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital/Neurology | Cinncinati | Ohio | 45229 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Legacy Emanuel Hospital | Portland | Oregon | 97227 | United States |
| Legacy Emanual Research | Portland | Oregon | 97232 | United States |
| Specially For Children | Austin | Texas | 78723 | United States |
| Novartis Investigative Site | Buenos Aires | Argentina |
| Novartis Investigative Site | Capital Federal | Argentina |
| Novartis Investigative Site | La Plata | Argentina |
| Novartis Investigative site | Brussels | Belgium |
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| Novartis Investigative Site | Laken | Belgium |
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| Novartis Investigative Site | Curitiba | Brazil |
| Novartis Investigative site | Porto Alegre | Brazil |
| Novartis Investigative site | Rio de Janeiro | Brazil |
| Novartis Investigative site | São Paulo | Brazil |
| Novartis Investigative site | Vancouver | British Columbia | Canada |
| Novartis Investigative site | Halifax | Nova Scotia | Canada |
| Novartis Investigative site | Toronto | Ontario | Canada |
| Novartis Investigative site | Montreal | Quebec | Canada |
| Novartis Investigative site | Calgary | Canada |
| Novartis Investigative site | Arhus N | Denmark |
| Novartis Investigative Site | Le Kremlin-Bicêtre | France |
| Novartis Investigative Site | Lyon | France |
| Novartis Investigative Site | Paris | France |
| Novartis Investigative Site | Strasbourg | France |
| Novartis Investigative Site | Bad Bamstedt | Germany |
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| Novartis Investigative Site | Freiburg im Breisgau | Germany |
| Novartis Investigative site | Garmisch-Partenkirch | Germany |
| Novartis Investigative Site | Geißen | Germany |
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| Novartis Investigative site | Thessaloniki | Greece |
| Novartis Investigative Site | Budapest | Hungary |
| Novartis Investigative Site | Haifa | Israel |
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| Novartis Investigative Site | Petah Tikva | Israel |
| Novartis Investigative Site | Ramat Gan | Israel |
| Novartis Investigative Site | Rehovot | Israel |
| Novartis Investigative Site | Bologna | Italy |
| Novartis Investigative Site | Florence | Italy |
| Novartis Investigative Site | Genova | Italy |
| Novartis Investigative site | Milan | Italy |
| Novartis Investigative site | Naples | Italy |
| Novartis Investigative site | Padova | Italy |
| Novartis Investigative site | Rome | Italy |
| Novartis Investigative site | Scafati | Italy |
| Novartis Investigative site | Torino | Italy |
| Novartis Investigative site | Utrecht | Netherlands |
| Novartis Investigative Site | Oslo | Norway |
| Novartis Investigative Site | Lima | Peru |
| Novartis Investigative site | Warsaw | Poland |
| Novartis Investigative site | Berea | Durban | South Africa |
| Novartis Investigative site | Mayville | Durban | South Africa |
| Novartis Investigative site | Pretoria | South Africa |
| Novartis Investigative site | Barcelona | Spain |
| Novartis Investigative site | Madrid | Spain |
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| Novartis Investigative site | Stockholm | Sweden |
| Novartis Investigative Site | Bern | Switzerland |
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| Novartis Investigative site | Ankara | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | Turkey (Türkiye) |
| Novartis Investigative site | Birmingham | United Kingdom |
| Novartis Investigative site | Liverpool | United Kingdom |
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| Novartis Investigative site | New Castle Upon Tyne | United Kingdom |
| Novartis Investigative site | Norwich | United Kingdom |
| Novartis Investigative site | Oxford | United Kingdom |
| Derived |
| Brachat AH, Grom AA, Wulffraat N, Brunner HI, Quartier P, Brik R, McCann L, Ozdogan H, Rutkowska-Sak L, Schneider R, Gerloni V, Harel L, Terreri M, Houghton K, Joos R, Kingsbury D, Lopez-Benitez JM, Bek S, Schumacher M, Valentin MA, Gram H, Abrams K, Martini A, Lovell DJ, Nirmala NR, Ruperto N; Pediatric Rheumatology International Trials Organization (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy. Arthritis Res Ther. 2017 Jan 23;19(1):13. doi: 10.1186/s13075-016-1212-x. |
| 26314396 | Derived | Grom AA, Ilowite NT, Pascual V, Brunner HI, Martini A, Lovell D, Ruperto N; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group; Leon K, Lheritier K, Abrams K. Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab. Arthritis Rheumatol. 2016 Jan;68(1):218-28. doi: 10.1002/art.39407. |
| 23252526 | Derived | Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat N, Horneff G, Brik R, McCann L, Kasapcopur O, Rutkowska-Sak L, Schneider R, Berkun Y, Calvo I, Erguven M, Goffin L, Hofer M, Kallinich T, Oliveira SK, Uziel Y, Viola S, Nistala K, Wouters C, Cimaz R, Ferrandiz MA, Flato B, Gamir ML, Kone-Paut I, Grom A, Magnusson B, Ozen S, Sztajnbok F, Lheritier K, Abrams K, Kim D, Martini A, Lovell DJ; PRINTO; PRCSG. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012 Dec 20;367(25):2396-406. doi: 10.1056/NEJMoa1205099. |
| Related Info | View source |
Patients received a single dose matching placebo of canakinumab on day 1. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo | Patients received a single dose matching placebo of canakinumab on day 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | 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) | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline, Day 15, Day 29 |
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| Secondary | Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria | 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) | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. | Posted | Number | percentage of participants | Baseline, Day 15, Day 29 |
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| Secondary | Percentage of Patients Achieving the Adapted ACR Pediatric 70 | 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) | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. | Posted | Number | percent of participants | Baseline, Day 15, Day 29 |
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| Secondary | Percentage of Patients Achieving the Adapted ACR Pediatric 90 | 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) | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. | Posted | Number | percent of participants | Baseline, Day 15, Day 29 |
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| Secondary | Percentage of Patients Achieving the Adapted ACR Pediatric 100 | 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 | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. | Posted | Number | percent of participants | baseline, Day 15, Day 29 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | 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. | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Day 15 |
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| Secondary | Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ | 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. | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Day 29 |
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| Secondary | Percentage of Patients Who Had Body Temperature ≤ 38°C | Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured. | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis. | Posted | Number | Percent of participants | Day 3 |
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| Secondary | Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50) | 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. | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Observed cases only were analyzed. | Posted | Least Squares Mean | Standard Error | units on a scale | Over 4 week study period (Baseline, Day 15, Day 29) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Disability Score Over Time by Use of the CHAQ | 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. | The Full Analysis Set (FAS) consisted of all randomized patients who received at least one dose of study drug. Only observed cases were used in the analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | At 4 week study period |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 43 | 17 | 43 | ||
| EG001 | Placebo | Patients received a single dose matching placebo of canakinumab on day 1. | 2 | 41 | 3 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Histiocytosis haematophagic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until publication of the pooled data (i.e., data from all sites) in the clinical trial or publication of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C541220 | canakinumab |
Not provided
Not provided
Not provided
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