Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2008-005479-82 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pediatric Rheumatology International Trials Organization | OTHER |
This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canakinumab | Experimental | In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. |
|
| Placebo | Placebo Comparator | Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| canakinumab | Drug | Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid | Ability to taper oral steroids: if dose reduced from start of Part I to end of Part Ic from > 0.8 mg/kg/day to ≤ 0.5 mg/kg/day, or from ≥ 0.5 mg/kg/day and ≤ 0.8 mg/kg/day by at least 0.3 mg/kg, or from any initial dose to ≤ 0.2 mg/kg/day, while maintaining a minimum adapted ACR 30 pediatric criterion. Patients on oral steroids at study entry who did not enter Part 1c are considered steroid tapering failures. | 32 Weeks |
| Part II: Survival Estimate of Time to Flare | Kaplan Meier estimate of the probability to experience a flare. Flare was defined as at least 1 of the following.
| Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic | 28 Weeks | |
| Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c | Start of Part Ic (After Week 8) to End of Part Ic (Week 28) |
Not provided
Inclusion Criteria:
Confirmed diagnosis of systemic juvenile idiopathic arthritis as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age.
-Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily for at least 3 days with accompanying symptoms
Active disease at the time of enrollment defined as follows:
No concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:
Exclusion criteria:
Other protocol inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital Research Inst | Little Rock | Arkansas | 72202 | United States | ||
| Children's National Medical Center |
| 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 |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Canakinumab | In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part I: Open Label |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II. |
|
| Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I | Adapted ACR Pediatric 30/50/70/90/100 criteria are defined as meeting all of the following:
| Baseline, 32 Weeks |
| Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein | Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (<10mg/L) C-Reactive Protein | Baseline, Week 32 |
| Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein | Duration in days in the study to the first minimum adapted ACR Pediatric 70 criteria and a normal (<10mg/L) C-Reactive Protein | Baseline, Week 32 |
| Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a | Day 3 |
| Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response | Kaplan Meier estimate of the time in days to the probability of worsening of the ACR response. ACR response is determined by the following items:
| Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks) |
| Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I | The childhood health assessment questionnaire, CHAQ was used to assess physical ability and functional status of patients as well as quality of life. The disability dimension consists 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". Parents choose from four response categories, ranging from 0(without any difficulty) to 3(unable to do). A negative change indicates improvement. | Baseline, End of Part I (Week 32) |
| Part II: Change in Disability Over Time by the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) | CHAQ-DI assessed physical ability and functional status of patients and quality of life. 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other "activities". Parents choose from 4 response categories, ranging from 0(without any difficulty) to 3(unable to do). Repeated measures Analysis of Covariance with treatment group, visit day, prednisone (or equivalent) dose and adapted ACR 70 response reached at the end of Part Id as covariates. | Start of Part II (Week 32), End of Part II ( total duration-88 weeks) |
| Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50) | The CHQ-PF50© is an instrument used to measure Health Related Quality of Life in children 5-18 from the parent's perspective. The questionnaire measures the following concepts: 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. Summaries are provided for Physical Health and Psychosocial Health. Scores range from 0-100. Increase in score represents improvement. | Baseline, End of Part I ( Week 32) |
| Part II: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50) | CHQ-PF50 measures Physical functioning, Role/social emotional, behavior and physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact-emotional, Parental impact-time, Family activities and cohesion. Summaries are provided for Physical Health and Psychosocial Health. An increase in score indicates improvement. Repeated measures Analysis of Covariance change from start of Part II with treatment group, visit day, prednisone(or equivalent) dose and adapted ACR70 Pediatric response reached at the end of Part Id as covariates. | Start Part II (Week 32), End Part II (total duration - 88 Weeks) |
| 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 |
| New England Medical Center - Department of Allergy | Boston | Massachusetts | 02111 | United States |
| Tufts Medical Center | 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 | Cincinnati | Ohio | 45229 | 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 |
| Novartis Investigative site | Ghent | Belgium |
| Novartis Investigative Site | Laken | Belgium |
| Novartis Investigative site | Leuven | Belgium |
| Novartis Investigative Site | Curitiba | Brazil |
| Novartis Investigative site | Porto Alegre | Brazil |
| Novartis Investigative site | Rio de Janiero | 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 | 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 |
| Novartis Investigative site | Berlin | Germany |
| Novartis Investigative Site | Bremen | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | Germany |
| Novartis Investigative Site | Geißen | Germany |
| Novartis Investigative Site | Hamburg | Germany |
| Novartis Investigative Site | Münster | Germany |
| Novartis Investigative Site | Saint Augustin | Germany |
| Novartis Investigative Site | Stuttgart | Germany |
| Novartis Investigative Site | Budapest | Hungary |
| Novartis Investigative Site | Haifa | Israel |
| Novartis Investigative Site | Kfar Saba | Israel |
| 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 | Johannesburg | South Africa |
| Novartis Investigative site | Pretoria | South Africa |
| Novartis Investigative site | Barcelona | Spain |
| Novartis Investigative site | Madrid | Spain |
| Novartis Investigative site | Valencia | Spain |
| Novartis Investigative site | Stockholm | Sweden |
| Novartis Investigative Site | Bern | Switzerland |
| Novartis Investigative site | Lausanne | Switzerland |
| Novartis Investigative site | Zurich | Switzerland |
| Novartis Investigative site | Ankara | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | Turkey (Türkiye) |
| 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 |
| FG001 | Placebo | Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. |
| Entered Part Ia |
|
| Entered Part Ib |
|
| Entered Part Ic |
|
| Entered Part 1d |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part II: Randomized Double Blind |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Canakinumab | In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid | Ability to taper oral steroids: if dose reduced from start of Part I to end of Part Ic from > 0.8 mg/kg/day to ≤ 0.5 mg/kg/day, or from ≥ 0.5 mg/kg/day and ≤ 0.8 mg/kg/day by at least 0.3 mg/kg, or from any initial dose to ≤ 0.2 mg/kg/day, while maintaining a minimum adapted ACR 30 pediatric criterion. Patients on oral steroids at study entry who did not enter Part 1c are considered steroid tapering failures. | Participants from the Full Analysis Set who were taking oral steroids at the beginning of Part I. | Posted | Number | 90% Confidence Interval | Percentage of participants | 32 Weeks |
|
|
| |||||||||||||||||||||||||
| Primary | Part II: Survival Estimate of Time to Flare | Kaplan Meier estimate of the probability to experience a flare. Flare was defined as at least 1 of the following.
| Full Analysis Set in Part II | Posted | Median | 95% Confidence Interval | Days | Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks) |
| |||||||||||||||||||||||||||
| Secondary | Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic | Participants from the Full Analysis set who were taking oral steroids at the start of the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c | Participants from the Full Analysis set who were taking oral steroids at the start of Part Ic. | Posted | Number | 90% Confidence Interval | Percentage of participants | Start of Part Ic (After Week 8) to End of Part Ic (Week 28) |
|
| |||||||||||||||||||||||||||
| Secondary | Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I | Adapted ACR Pediatric 30/50/70/90/100 criteria are defined as meeting all of the following:
| Participants from the full analysis set with an assessment at the given time-point. | Posted | Number | Percentage of participants | Baseline, 32 Weeks |
| ||||||||||||||||||||||||||||
| Secondary | Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein | Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (<10mg/L) C-Reactive Protein | Participants from the Full Analysis Set Part I with ACR 50 and a Normal CRP. | Posted | Mean | Standard Deviation | Days | Baseline, Week 32 |
|
| ||||||||||||||||||||||||||
| Secondary | Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein | Duration in days in the study to the first minimum adapted ACR Pediatric 70 criteria and a normal (<10mg/L) C-Reactive Protein | Participants from the Full Analysis Set Part I with ACR 70 and a Normal CRP. | Posted | Mean | Standard Deviation | Days | Baseline, Week 32 |
|
| ||||||||||||||||||||||||||
| Secondary | Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a | Participants from the Full Analysis Set Part I with temperature readings at Day 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 3 |
|
| |||||||||||||||||||||||||||
| Secondary | Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response | Kaplan Meier estimate of the time in days to the probability of worsening of the ACR response. ACR response is determined by the following items:
| Full Analysis Set Part II | Posted | Median | 95% Confidence Interval | Days | Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks) |
| |||||||||||||||||||||||||||
| Secondary | Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I | The childhood health assessment questionnaire, CHAQ was used to assess physical ability and functional status of patients as well as quality of life. The disability dimension consists 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". Parents choose from four response categories, ranging from 0(without any difficulty) to 3(unable to do). A negative change indicates improvement. | Participants from the Full Analysis Set Part I with data at baseline and End of Part I. | Posted | Median | Full Range | Score on a scale | Baseline, End of Part I (Week 32) |
| |||||||||||||||||||||||||||
| Secondary | Part II: Change in Disability Over Time by the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) | CHAQ-DI assessed physical ability and functional status of patients and quality of life. 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other "activities". Parents choose from 4 response categories, ranging from 0(without any difficulty) to 3(unable to do). Repeated measures Analysis of Covariance with treatment group, visit day, prednisone (or equivalent) dose and adapted ACR 70 response reached at the end of Part Id as covariates. | Full Analysis set Part II. | Posted | Least Squares Mean | Standard Error | Score on a scale | Start of Part II (Week 32), End of Part II ( total duration-88 weeks) |
| |||||||||||||||||||||||||||
| Secondary | Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50) | The CHQ-PF50© is an instrument used to measure Health Related Quality of Life in children 5-18 from the parent's perspective. The questionnaire measures the following concepts: 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. Summaries are provided for Physical Health and Psychosocial Health. Scores range from 0-100. Increase in score represents improvement. | Participants from the Full Analysis Set Part I-age 5 to 18 years. | Posted | Median | Full Range | Score on a scale | Baseline, End of Part I ( Week 32) |
| |||||||||||||||||||||||||||
| Secondary | Part II: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50) | CHQ-PF50 measures Physical functioning, Role/social emotional, behavior and physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact-emotional, Parental impact-time, Family activities and cohesion. Summaries are provided for Physical Health and Psychosocial Health. An increase in score indicates improvement. Repeated measures Analysis of Covariance change from start of Part II with treatment group, visit day, prednisone(or equivalent) dose and adapted ACR70 Pediatric response reached at the end of Part Id as covariates. | Full Analysis Set Part II-patients aged 5-18 years. | Posted | Least Squares Mean | Standard Error | Score on a scale | Start Part II (Week 32), End Part II (total duration - 88 Weeks) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Canakinumab: Part I | In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. | 15 | 177 | 138 | 177 | ||
| EG001 | Canakinumab: Part II | Participants received 4 mg/kg canakinumab subcutaneous injection in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. | 6 | 50 | 40 | 50 | ||
| EG002 | Placebo: Part II | Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. | 6 | 50 | 35 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Lymph node abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Coagulation test abnormal | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Histiocytosis haematophagic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Haptoglobin decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Splenic neoplasm malignancy unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 14.0 | 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 the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D001171 | Arthritis, Juvenile |
| 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
| Withdrawal by Subject |
|
| Protocol deviation |
|
| OG001 | Placebo | Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. |
|
|
|
|
|
|
|
|
|
Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. |
|
|
|
|
| OG001 | Placebo | Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. |
|
|
|
|
| OG001 | Placebo | Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II. |
|
|