A Phase 3 interventional study of Canakinumab in Systemic Juvenile Idiopathic Arthritis, sponsored by Novartis Pharmaceuticals. Completed at 7 sites in Japan. Open to participants aged 2 Years to 19 Years. Per ClinicalTrials.gov, last updated 2019-09-13.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 19 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: Canakinumab
canakinumab was provided as a 150 mg/1 mL solution for subcutaneous injection and administered at 4mg/kg every 4 weeks.
Also known as: ACZ885
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.
Time frame: 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
Time frame: Week 28
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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: > 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Weeks 28, 48, 96, 144, EOS (up to Week 164)
Serum Concentration of Canakinumab
To evaluate serum concentration (mean, standard deviation) of canakinumab.
Time frame: 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.
Time frame: Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164)
It was planned to enroll approximately 20 patients in this study. There were19 patients enrolled and data from all patients were analyzed.
| Milestone | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Started | 19 |
| Completed | 16 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Lack of efficacy | 2 |
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.
| Percentage of Participants | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria | 100.0 |
To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully at Week 28
| Percentage of Participants | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully | 73.7 |
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%.
| Percentage of Participants | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Week 4 adapted ACR Pediatric 30 | 94.7 |
| Week 4 adapted ACR Pediatric 50 | 94.7 |
| Week 4 adapted ACR Pediatric 70 | 94.7 |
| Week 4 adapted ACR Pediatric 90 | 84.2 |
| Week 4 adapted ACR Pediatric 100 | 47.4 |
| Week 8 adapted ACR Pediatric 30 | 100.0 |
| Week 8 adapted ACR Pediatric 50 | 100.0 |
| Week 8 adapted ACR Pediatric 70 | 100.0 |
| Week 8 adapted ACR Pediatric 90 | 89.5 |
| Week 8 adapted ACR Pediatric 100 | 68.4 |
| Week 28 adapted ACR Pediatric 30 | 100.0 |
| Week 28 adapted ACR Pediatric 50 | 100.0 |
| Week 28 adapted ACR Pediatric 70 | 100.0 |
| Week 28 adapted ACR Pediatric 90 | 100.0 |
| Week 28 adapted ACR Pediatric 100 | 56.3 |
| Week 48 adapted ACR Pediatric 30 | 100.0 |
| Week 48 adapted ACR Pediatric 50 | 100.0 |
| Week 48 adapted ACR Pediatric 70 | 100.0 |
| Week 48 adapted ACR Pediatric 90 | 87.5 |
| Week 48 adapted ACR Pediatric 100 | 68.8 |
| Week 96 adapted ACR Pediatric 30 | 100.0 |
| Week 96 adapted ACR Pediatric 50 | 100.0 |
| Week 96 adapted ACR Pediatric 70 | 100.0 |
| Week 96 adapted ACR Pediatric 90 | 93.8 |
| Week 96 adapted ACR Pediatric 100 | 62.5 |
| Week 144 adapted ACR Pediatric 30 | 100.0 |
| Week 144 adapted ACR Pediatric 50 | 100.0 |
| Week144 adapted ACR Pediatric 70 | 100.0 |
| Week 144 adapted ACR Pediatric 90 | 100.0 |
| Week 144 adapted ACR Pediatric 100 | 80.0 |
| Week EOS adapted ACR Pediatric 30 | 89.5 |
| End of Study (EOS) adapted ACR Pediatric 50 | 89.5 |
| EOS adapted ACR Pediatric 70 | 89.5 |
| EOS adapted ACR Pediatric 90 | 84.2 |
| EOS adapted ACR Pediatric 100 | 63.2 |
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.
| units on a scale | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Week 4 | -60.2 ± 32.27 |
| Week 8 | -62.2 ± 28.23 |
| Week 28 | -62.2 ± 28.61 |
| Week 48 | -63.9 ± 28.81 |
| Week 96 | -63.1 ± 26.99 |
| Week 144 | -61.0 ± 37.24 |
| EOS | -61.4 ± 31.05 |
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.
| units on a scale | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Week 4 | -64.4 ± 40.80 |
| Week 8 | -73.5 ± 24.05 |
| Week 28 | -71.9 ± 23.13 |
| Week 48 | -68.6 ± 28.67 |
| Week 96 | -68.4 ± 27.72 |
| Week 144 | -72.8 ± 25.65 |
| EOS | -68.1 ± 26.29 |
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.
| units on a scale | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Week 4 | -0.833 ± 0.7750 |
| Week 8 | -0.912 ± 0.7338 |
| Week 28 | -0.998 ± 0.7871 |
| Week 48 | -1.013 ± 0.7963 |
| Week 96 | -0.951 ± 0.8381 |
| Week 144 | -1.026 ± 0.9465 |
| EOS | -0.938 ± 0.7682 |
ACR component, Number of joints with active arthritis was assessed as the forth response variables of ACR Pediatric Criteria.
| joints | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Week 4 | -5.2 ± 4.87 |
| Week 8 | -6.2 ± 7.71 |
| Week 28 | -4.4 ± 3.44 |
| Week 48 | -4.4 ± 3.44 |
| Week 96 | -4.4 ± 3.18 |
| Week 144 | -5.2 ± 2.68 |
| EOS | -5.6 ± 8.10 |
ACR component, Number of joints with limitation of motion is the fifth response variable in the ACR ped criteria.
| joints | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Week 4 | -3.9 ± 4.02 |
| Week 8 | -4.2 ± 4.30 |
| Week 28 | -3.4 ± 3.79 |
| Week 48 | -3.5 ± 3.78 |
| Week 96 | -3.4 ± 3.59 |
| Week 144 | -3.8 ± 2.86 |
| EOS | -3.7 ± 4.81 |
ACR component, Number of participants having fever is the seventh response variable in the ACR ped criteria.
| participants | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Baseline | 19 |
| Day 3 | 16 |
| Week 2 | 2 |
| Week 8 | 0 |
| Week 28 | 0 |
| Week 48 | 0 |
| Week 56 | 1 |
| Week 96 | 0 |
| Week 124 | 1 |
| Week 144 | 0 |
| EOS | 0 |
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.
| Percentage change | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Week 4 | -89.45 ± 41.431 |
| Week 8 | -96.95 ± 6.915 |
| Week 28 | -98.19 ± 2.567 |
| Week 48 | -97.64 ± 6.333 |
| Week 96 | -97.95 ± 3.730 |
| Week 144 | -98.58 ± 1.330 |
| EOS | -89.71 ± 20.717 |
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
| Percentage of participants | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| >Day 3 =<Week 2 | 5.3 |
| >Week 2 =<Week 4 | 5.3 |
| >Week 4 =<Week 8 | 5.3 |
| >Week 8 =<Week 12 | 5.6 |
| >Week 12 =<Week 16 | 5.6 |
| >Week 92 =<Week 96 | 6.3 |
| >Week 104 =<Week 108 | 7.7 |
| >Week 120 =<Week 124 | 12.5 |
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
| Percentage of participants | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Week 4 | 63.2 |
| Week 8 | 63.2 |
| Week 28 | 75.0 |
| Week 48 | 75.0 |
| Week 96 | 75.0 |
| Week 144 | 80.0 |
| EOS | 68.4 |
To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully over time
| percentage of perticipants | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Week 28 | 87.5 |
| Week 48 | 81.3 |
| Week 96 | 87.5 |
| Week 144 | 100.0 |
| EOS | 66.7 |
To evaluate the change from baseline of corticosteroids dose reduction with canakinumab treatment over time
| mg/kg/day | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Week 28 | -0.133 ± 0.1676 |
| Week 48 | -0.195 ± 0.2317 |
| Week 96 | -0.226 ± 0.2618 |
| Week 144 | -0.296 ± 0.2545 |
| EOS | -0.171 ± 0.2334 |
To evaluate serum concentration (mean, standard deviation) of canakinumab.
| μg/mL | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Baseline | 0.01 ± 0.05 |
| Week 4 | 15.7 ± 5.19 |
| Week 24 | 31.3 ± 11.5 |
| Week 48 | 31.1 ± 9.08 |
| Week 72 | 30.6 ± 8.95 |
| Week 96 | 29.5 ± 8.49 |
| EOS | 28.3 ± 6.41 |
To evaluate serum total IL-1 Beta concentration by visit.
| pg/mL | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Baseline | 0.72 ± 0.97 |
| Week 4 | 49.8 ± 36.3 |
| Week 24 | 85.2 ± 61.6 |
| Week 48 | 81.2 ± 62.0 |
| Week 72 | 75.3 ± 36.6 |
| Week 96 | 74.4 ± 35.9 |
| EOS | 101 ± 89.1 |
Collected over Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to approximately 39 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Canakinumab 4 mg/kg Every 4 Weeks | 0/19 (0%) | 10/19 (52.6%) | 19/19 (100%) |
| Event | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Still's diseaseMusculoskeletal and connective tissue disorders | 6/19 |
| Histiocytosis haematophagicBlood and lymphatic system disorders | 3/19 |
| Adrenal insufficiencyEndocrine disorders | 2/19 |
| PyrexiaGeneral disorders | 2/19 |
| InfluenzaInfections and infestations | 2/19 |
| Epstein-Barr virus infectionInfections and infestations | 1/19 |
| GastroenteritisInfections and infestations | 1/19 |
| PharyngitisInfections and infestations | 1/19 |
| VaricellaInfections and infestations | 1/19 |
| Viral infectionInfections and infestations | 1/19 |
| Event | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| NasopharyngitisInfections and infestations | 12/19 |
| ConstipationGastrointestinal disorders | 6/19 |
| GastroenteritisInfections and infestations | 6/19 |
| HeadacheNervous system disorders | 6/19 |
| Injection site reactionGeneral disorders | 5/19 |
| Hepatic function abnormalHepatobiliary disorders | 5/19 |
| BronchitisInfections and infestations | 4/19 |
| HordeolumInfections and infestations | 4/19 |
| InfluenzaInfections and infestations | 4/19 |
| Upper respiratory tract infectionInfections and infestations | 4/19 |
The Full Analysis Set (FAS) consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.
| Age, Continuous(Years) | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Mean | 9.9 ± 4.47 |
| Sex: Female, Male(Participants) | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Female | 13 |
| Male | 6 |
| Race/Ethnicity, Customized(Participants) | Canakinumab 4 mg/kg Every 4 Weeks |
|---|---|
| Asian | 19 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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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