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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002355-15 | EudraCT Number |
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This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA) data at Week 28 and 48 from this study supported a registration submission of canakinumab in the indication of SJIA in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canakinumab | Experimental | All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canakinumab | Biological | canakinumab was provided as a 150 mg/1 mL solution for subcutaneous injection and administered at 4mg/kg every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Minimum Adapted ACR Pediatric 30 criteria is defined as improvement from baseline at least 30% in at least 3 of response variables 1 to 6 in Adapted ACR Pediatric response variables and no intermittent fever (i.e. axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. Adapted ACR Pediatric response variables consists of following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the Child Health Assessment Questionnaire (CHAQ); 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to SJIA during the preceding week. | Week 8 |
| Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully | To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully at Week 28 | Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Adapted ACR Pediatric 30/50/70/90/100 criteria was assessed based on the following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the CHAQ; 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to 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 6 response variables and no intermittent fever in the preceding week (variable 7) with no more than one variable 1-6 worsening by more than 30%. |
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Inclusion Criteria
- Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR) definition (Petty, et al. 2004) that must have occurred at least 3 months prior to enrollment with an 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/quotidian for at least 3 days and accompanied by one or more of the following: Rash due to SJIA, lymphadenopathy, Hepatomegaly/Splenomegaly, Serositis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ōbu | Aichi-ken | 474 8710 | Japan | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32552266 | Derived | Nishimura K, Hara R, Umebayashi H, Takei S, Iwata N, Imagawa T, Shimizu M, Tomiita M, Seko N, Kitawaki T, Yokota S. Efficacy and safety of canakinumab in systemic juvenile idiopathic arthritis: 48-week results from an open-label phase III study in Japanese patients. Mod Rheumatol. 2021 Jan;31(1):226-234. doi: 10.1080/14397595.2020.1783163. Epub 2020 Jul 29. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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It was planned to enroll approximately 20 patients in this study. There were19 patients enrolled and data from all patients were analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Canakinumab 4 mg/kg Every 4 Weeks | All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Full Analysis Set (FAS) consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Canakinumab 4 mg/kg Every 4 Weeks | All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | Minimum Adapted ACR Pediatric 30 criteria is defined as improvement from baseline at least 30% in at least 3 of response variables 1 to 6 in Adapted ACR Pediatric response variables and no intermittent fever (i.e. axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. Adapted ACR Pediatric response variables consists of following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the Child Health Assessment Questionnaire (CHAQ); 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to SJIA during the preceding week. | The Full Analysis Set (FAS) consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Number | Percentage of Participants | Week 8 |
Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 39 months.
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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 4 mg/kg Every 4 Weeks | All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 12, 2014 | Jan 30, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2017 | Jan 30, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D018771 | Arthralgia |
| C565798 | Rheumatoid Arthritis, Systemic Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C541220 | canakinumab |
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| Weeks 4, 8, 28, 48, 96, 144, end of study (EOS) (up to Week 164) |
| Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Physician's Global Assessment of Disease Activity | ACR component, Physician's Global Assessment of disease activity on a 0 - 100 mm VAS by visit is the first response ACR variable in the ACR pediatric criteria. The VAS scale ranges from no disease activity (0 mm) to very severe disease activity (100 mm). Lower scale indicates decreased disease activity. Change from baseline was calculated by subtracting baseline value from post baseline value. | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
| Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Parent's or Patient's Global Assessment of Patient's Overall Well-being as Part of CHAQ | ACR component, Parent's or Patient's (if appropriate in age)Global Assessment of patient's overall well-being as part of CHAQ on a 0 - 100 mm VAS by visit is the second response variable in the ACR pediatric criteria. The VAS scale ranges from 0-100 mm, from very well (0 mm) to very poor (100 mm). Lower scale indicates improvement of patient's overall well-being. Absolute change is calculated by subtracting baseline value from post baseline value. | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS up to Week 164 |
| Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Functional Ability Score | Disability Score as part of CHAQ per functional ability score (range from 0 to 3) is one of the variable in the ACR ped criteria. The CHAQ was used to assess physical ability & functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activity categories of daily living: dressing & grooming, arising, eating, walking, reaching, personal hygiene, gripping & other "activities". Subjects choose from 4 responses, ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) & 3 (unable to do). Standard Disability Index (SDI) was computed by summing up the computed scores for each activity category and dividing by the number of categories answered. The lower the response the more positive the results & the higher the response, the less positive the results. Change from baseline was calculated by subtracting baseline value from post baseline value. | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
| Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Active Arthritis | ACR component, Number of joints with active arthritis was assessed as the forth response variables of ACR Pediatric Criteria. | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
| Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Limitation of Motion | ACR component, Number of joints with limitation of motion is the fifth response variable in the ACR ped criteria. | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
| Number of Participants Having Fever in the Adapted ACR Pediatric Criteria of Canakinumab Over Time | ACR component, Number of participants having fever is the seventh response variable in the ACR ped criteria. | Baseline, Day 3, Weeks 2, 8, 28, 48, 56, 96, 124, 144, EOS (up to Week 164) |
| Percentage Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Standardized C-Reactive Protein (CRP) | ACR component, Standardized CRP is the sixth response variable in the ACR ped criteria. CRP values were standardized to a normal range of 0 to 10 mg/L. | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
| Percentage of Participants Who Had Flares With Canakinumab Treatment Over Time | Flare was defined by at least 1 of the following: Reappearance of SJIA-related (e.g., not due to infection) fever (> 38°C) lasting for at least 2 consecutive days &/OR Flare according to the JIA pediatric criteria for flare (all criteria must be met): ≥ 30% worsening in at least 3 of the 6 response variables and ≥ 30% improvement in at not more than 1 of the 6 response variables if the physician's or parent's global assessment is 1of 3 response variables used to define flare, worsening of ≥ 20 mm must be present, if the number of active joints or joints with limitation of motion is one of 3 response variables used to define flare, worsening in ≥ 2 joints must be present if CRP is used to define flare, CRP must be > 30 mg/L | > Day3, to <= Week 124 |
| Percentage of Participants Who Achieved Inactive Disease (With and Without Duration of Morning Stiffness) With Canakinumab Treatment Over Time | Inactive disease was defined as meeting all of the following: No joints with active arthritis; No fever (body temperature ≤ 38°C); No rheumatoid rash, serositis, splenomegaly, hepatomegaly or generalized lymphadenopathy attributable to JIA; Normal CRP; Physician's global assessment of disease activity score ≤ 10 mm | Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
| Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully Over Time | To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully over time | Weeks 28, 48, 96, 144, EOS (up to Week 164) |
| Absolute Change From Baseline of Corticosteroids Dose Reduction With Canakinumab Treatment Over Time | To evaluate the change from baseline of corticosteroids dose reduction with canakinumab treatment over time | Baseline, Weeks 28, 48, 96, 144, EOS (up to Week 164) |
| Serum Concentration of Canakinumab | To evaluate serum concentration (mean, standard deviation) of canakinumab. | Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164) |
| Pharmacodynamics (PD) Assessment: Total IL-1 Beta | To evaluate serum total IL-1 Beta concentration by visit. | Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164) |
| Chiba |
| Chiba |
| 266-0007 |
| Japan |
| Novartis Investigative Site | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Novartis Investigative Site | Kagoshima | Kagoshima-ken | 890 8520 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 232-8555 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 236-0004 | Japan |
| Novartis Investigative Site | Sendai | Miyagi | 989-3126 | Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Canakinumab 4 mg/kg Every 4 Weeks | All patients received canakinumab (ACZ885) as open-label study medication. Patients were administered canakinumab 4 mg/kg every 4 weeks. The maximal total single dose of canakinumab allowed was 300 mg. |
|
|
| Primary | Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully | To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully at Week 28 | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Number | Percentage of Participants | Week 28 |
|
|
|
| Secondary | Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time | Adapted ACR Pediatric 30/50/70/90/100 criteria was assessed based on the following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the CHAQ; 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to 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 6 response variables and no intermittent fever in the preceding week (variable 7) with no more than one variable 1-6 worsening by more than 30%. | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Number | Percentage of Participants | Weeks 4, 8, 28, 48, 96, 144, end of study (EOS) (up to Week 164) |
|
|
|
| Secondary | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Physician's Global Assessment of Disease Activity | ACR component, Physician's Global Assessment of disease activity on a 0 - 100 mm VAS by visit is the first response ACR variable in the ACR pediatric criteria. The VAS scale ranges from no disease activity (0 mm) to very severe disease activity (100 mm). Lower scale indicates decreased disease activity. Change from baseline was calculated by subtracting baseline value from post baseline value. | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
|
|
|
| Secondary | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Parent's or Patient's Global Assessment of Patient's Overall Well-being as Part of CHAQ | ACR component, Parent's or Patient's (if appropriate in age)Global Assessment of patient's overall well-being as part of CHAQ on a 0 - 100 mm VAS by visit is the second response variable in the ACR pediatric criteria. The VAS scale ranges from 0-100 mm, from very well (0 mm) to very poor (100 mm). Lower scale indicates improvement of patient's overall well-being. Absolute change is calculated by subtracting baseline value from post baseline value. | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS up to Week 164 |
|
|
|
| Secondary | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Functional Ability Score | Disability Score as part of CHAQ per functional ability score (range from 0 to 3) is one of the variable in the ACR ped criteria. The CHAQ was used to assess physical ability & functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activity categories of daily living: dressing & grooming, arising, eating, walking, reaching, personal hygiene, gripping & other "activities". Subjects choose from 4 responses, ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) & 3 (unable to do). Standard Disability Index (SDI) was computed by summing up the computed scores for each activity category and dividing by the number of categories answered. The lower the response the more positive the results & the higher the response, the less positive the results. Change from baseline was calculated by subtracting baseline value from post baseline value. | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
|
|
|
| Secondary | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Active Arthritis | ACR component, Number of joints with active arthritis was assessed as the forth response variables of ACR Pediatric Criteria. | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Mean | Standard Deviation | joints | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
|
|
|
| Secondary | Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Limitation of Motion | ACR component, Number of joints with limitation of motion is the fifth response variable in the ACR ped criteria. | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Mean | Standard Deviation | joints | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
|
|
|
| Secondary | Number of Participants Having Fever in the Adapted ACR Pediatric Criteria of Canakinumab Over Time | ACR component, Number of participants having fever is the seventh response variable in the ACR ped criteria. | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Number | participants | Baseline, Day 3, Weeks 2, 8, 28, 48, 56, 96, 124, 144, EOS (up to Week 164) |
|
|
|
| Secondary | Percentage Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Standardized C-Reactive Protein (CRP) | ACR component, Standardized CRP is the sixth response variable in the ACR ped criteria. CRP values were standardized to a normal range of 0 to 10 mg/L. | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Mean | Standard Deviation | Percentage change | Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
|
|
|
| Secondary | Percentage of Participants Who Had Flares With Canakinumab Treatment Over Time | Flare was defined by at least 1 of the following: Reappearance of SJIA-related (e.g., not due to infection) fever (> 38°C) lasting for at least 2 consecutive days &/OR Flare according to the JIA pediatric criteria for flare (all criteria must be met): ≥ 30% worsening in at least 3 of the 6 response variables and ≥ 30% improvement in at not more than 1 of the 6 response variables if the physician's or parent's global assessment is 1of 3 response variables used to define flare, worsening of ≥ 20 mm must be present, if the number of active joints or joints with limitation of motion is one of 3 response variables used to define flare, worsening in ≥ 2 joints must be present if CRP is used to define flare, CRP must be > 30 mg/L | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Number | Percentage of participants | > Day3, to <= Week 124 |
|
|
|
| Secondary | Percentage of Participants Who Achieved Inactive Disease (With and Without Duration of Morning Stiffness) With Canakinumab Treatment Over Time | Inactive disease was defined as meeting all of the following: No joints with active arthritis; No fever (body temperature ≤ 38°C); No rheumatoid rash, serositis, splenomegaly, hepatomegaly or generalized lymphadenopathy attributable to JIA; Normal CRP; Physician's global assessment of disease activity score ≤ 10 mm | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Number | Percentage of participants | Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164) |
|
|
|
| Secondary | Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully Over Time | To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully over time | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Number | percentage of perticipants | Weeks 28, 48, 96, 144, EOS (up to Week 164) |
|
|
|
| Secondary | Absolute Change From Baseline of Corticosteroids Dose Reduction With Canakinumab Treatment Over Time | To evaluate the change from baseline of corticosteroids dose reduction with canakinumab treatment over time | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Mean | Standard Deviation | mg/kg/day | Baseline, Weeks 28, 48, 96, 144, EOS (up to Week 164) |
|
|
|
| Secondary | Serum Concentration of Canakinumab | To evaluate serum concentration (mean, standard deviation) of canakinumab. | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Mean | Standard Deviation | μg/mL | Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164) |
|
|
|
| Secondary | Pharmacodynamics (PD) Assessment: Total IL-1 Beta | To evaluate serum total IL-1 Beta concentration by visit. | The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab. | Posted | Mean | Standard Deviation | pg/mL | Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164) |
|
|
|
| 0 |
| 19 |
| 10 |
| 19 |
| 19 |
| 19 |
| Adrenal insufficiency | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Epstein-Barr virus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Still's disease | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Somatic symptom disorder | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
|
| Motion sickness | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (21.0) | Systematic Assessment |
|
| Allergy to arthropod sting | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Angular cheilitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Lice infestation | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood creatine phosphokinase decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
|
| Hyperalbuminaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Still's disease | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Histiocytic necrotising lymphadenitis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Macule | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (21.0) | 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Week 4 adapted ACR Pediatric 70 |
|
|
| Week 4 adapted ACR Pediatric 90 |
|
|
| Week 4 adapted ACR Pediatric 100 |
|
|
| Week 8 adapted ACR Pediatric 30 |
|
|
| Week 8 adapted ACR Pediatric 50 |
|
|
| Week 8 adapted ACR Pediatric 70 |
|
|
| Week 8 adapted ACR Pediatric 90 |
|
|
| Week 8 adapted ACR Pediatric 100 |
|
|
| Week 28 adapted ACR Pediatric 30 |
|
|
| Week 28 adapted ACR Pediatric 50 |
|
|
| Week 28 adapted ACR Pediatric 70 |
|
|
| Week 28 adapted ACR Pediatric 90 |
|
|
| Week 28 adapted ACR Pediatric 100 |
|
|
| Week 48 adapted ACR Pediatric 30 |
|
|
| Week 48 adapted ACR Pediatric 50 |
|
|
| Week 48 adapted ACR Pediatric 70 |
|
|
| Week 48 adapted ACR Pediatric 90 |
|
|
| Week 48 adapted ACR Pediatric 100 |
|
|
| Week 96 adapted ACR Pediatric 30 |
|
|
| Week 96 adapted ACR Pediatric 50 |
|
|
| Week 96 adapted ACR Pediatric 70 |
|
|
| Week 96 adapted ACR Pediatric 90 |
|
|
| Week 96 adapted ACR Pediatric 100 |
|
|
| Week 144 adapted ACR Pediatric 30 |
|
|
| Week 144 adapted ACR Pediatric 50 |
|
|
| Week144 adapted ACR Pediatric 70 |
|
|
| Week 144 adapted ACR Pediatric 90 |
|
|
| Week 144 adapted ACR Pediatric 100 |
|
|
| Week EOS adapted ACR Pediatric 30 |
|
|
| End of Study (EOS) adapted ACR Pediatric 50 |
|
|
| EOS adapted ACR Pediatric 70 |
|
|
| EOS adapted ACR Pediatric 90 |
|
|
| EOS adapted ACR Pediatric 100 |
|
|
|
| Week 28 |
|
|
| Week 48 |
|
|
| Week 96 |
|
|
| Week 144 |
|
|
| EOS |
|
|
|
| Week 28 |
|
|
| Week 48 |
|
|
| Week 96 |
|
|
| Week 144 |
|
|
| EOS |
|
|
|
| Week 28 |
|
|
| Week 48 |
|
|
| Week 96 |
|
|
| Week 144 |
|
|
| EOS |
|
|
|
| Week 28 |
|
|
| Week 48 |
|
|
| Week 96 |
|
|
| Week 144 |
|
|
| EOS |
|
|
|
| Week 28 |
|
|
| Week 48 |
|
|
| Week 96 |
|
|
| Week 144 |
|
|
| EOS |
|
|
|
| Week 2 |
|
|
| Week 8 |
|
|
| Week 28 |
|
|
| Week 48 |
|
|
| Week 56 |
|
|
| Week 96 |
|
|
| Week 124 |
|
|
| Week 144 |
|
|
| EOS |
|
|
|
| Week 28 |
|
|
| Week 48 |
|
|
| Week 96 |
|
|
| Week 144 |
|
|
| EOS |
|
|
|
| >Week 4 =<Week 8 |
|
|
| >Week 8 =<Week 12 |
|
|
| >Week 12 =<Week 16 |
|
|
| >Week 92 =<Week 96 |
|
|
| >Week 104 =<Week 108 |
|
|
| >Week 120 =<Week 124 |
|
|
|
| Week 28 |
|
|
| Week 48 |
|
|
| Week 96 |
|
|
| Week 144 |
|
|
| EOS |
|
|
|
| Week 96 |
|
|
| Week 144 |
|
|
| EOS |
|
|
|
| Week 96 |
|
|
| Week 144 |
|
|
| EOS |
|
|
|
| Week 24 |
|
|
| Week 48 |
|
|
| Week 72 |
|
|
| Week 96 |
|
|
| EOS |
|
|
|
| Week 24 |
|
|
| Week 48 |
|
|
| Week 72 |
|
|
| Week 96 |
|
|
| EOS |
|
|