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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004867-29 | EudraCT Number |
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The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.
This two-part open-label study was to assess 2 different canakinumab taper regimens in patients with clinical remission (inactive disease for at least 24 continuous weeks) on canakinumab treatment without concomitant corticosteroids (CS) or methotrexate (MTX). The study was also to collect long term safety and tolerability data on SJIA patients treated with canakinumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canakinumab Dose Reduction | Experimental | All patients received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 1 in Part II of the study: Canakinumab was administered at a reduced dose (2 mg/kg every 4 weeks). If the patient continued to maintain inactive disease for 24 additional weeks, canakinumab was administered at 1mg/kg every 4 weeks. If the patient continued to maintain inactive disease for another 24 additional weeks, canakinumab treatment was discontinued. |
|
| Canakinumab Dose Interval Prolongation | Experimental | All participants received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 2 in Part II of the study: Canakinumab dose interval was prolonged to a regimen of 4mg/kg every 8 weeks. If the patient continued to be stable with inactive disease for 24 additional weeks, canakinumab dose interval was prolonged to a regimen of 4mg/kg every 12 weeks. If the patient was clinically stable with inactive disease for another 24 additional weeks, canakinumab treatment was discontinued. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACZ885 150 mg (Canakinumab) | Drug | Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. | The primary efficacy variable for Part II was the proportion of patients in clinical remission on canakinumab 4 mg/kg (+/- concomitant NSAID only) who were able to remain on a reduced dose or on prolonged dose interval for at least 24 consecutive weeks. As the primary objective was to show statistically significance in at least one of canakinumab treatment arms (reduced dose and prolonged dose interval arms) in Part II then the Type I error rate 5% was controlled and split to 2.5%. Clinical remission per protocol is defined as the maintenance of inactive disease for at least 6 months (24consecutive weeks) while on therapy. The primary analysis considered both inactive disease status and the patient dose step duration. In the event the inactive disease status was missing, yet the patient remained at the same dose level through the next visit with the same disease status, it was concluded that inactive disease was maintained during this time period and was carried forward. | baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 | AEs, Deaths, other serious adverse events or discontinuations due to AE, Part I (Safety set) | During study parts I and II. The estimated study duration is not more than 216 weeks (with an average expected duration of 108 weeks). |
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Inclusion Criteria:
Cohort 1:
• Patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for Systemic Juvenile Idiopathic Arthritis (SJIA) and have inactive disease at the last visit in Study CACZ885G2301E1
Cohort 2:
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 | Los Angeles | California | 90027 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32783351 | Derived | Quartier P, Alexeeva E, Constantin T, Chasnyk V, Wulffraat N, Palmblad K, Wouters C, I Brunner H, Marzan K, Schneider R, Horneff G, Martini A, Anton J, Wei X, Slade A, Ruperto N, Abrams K; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group. Tapering Canakinumab Monotherapy in Patients With Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results From a Phase IIIb/IV Open-Label, Randomized Study. Arthritis Rheumatol. 2021 Feb;73(2):336-346. doi: 10.1002/art.41488. Epub 2020 Dec 11. |
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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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75 patients (Cohort 1: 56 and Cohort 2: 20) qualified for Study Part II and were randomized to receive canakinumab at either a reduced dose (n=38) or a prolonged dose interval (n=37)
182 enrolled but 16 qualified immediately for Part II & were randomized while 166 continued in Part I & were treated with canakinumab 4 mg/kg every 4 weeks until study end unless they discontinued, or until they qualified for Part II. Of these, 40 discontinued. Most frequent reason was lack of efficacy
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Participants from study CACZ885G2301E1, aged ≥ 2 to < 20 years at the time of the patient's first dose of canakinumab, who at the time of evaluation for participation in CACZ885G2306 were being treated with canakinumab 4mg/kg and had inactive disease |
| FG001 | PART 1: Cohort 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
|
Not provided
A two-part open-label study that collected long-term efficacy, safety, and tolerability data from SJIA patients receiving canakinumab treatment who had inactive disease at the last visit in Study CACZ885G2301E1 (Cohort 1), and from SJIA patients who were canakinumab treatment-naïve and had active disease at the time of screening for this study (Cohort 2)
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No blinding was required in this open-label study
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|
| Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 2 | AEs, Deaths, other serious adverse events or discontinuations due to AE, Part II (Safety set) | During study parts I and II, estimated study duration was not more than 216 weeks (with an average duration of 108 weeks). |
| Columbus |
| Ohio |
| 43205 |
| United States |
| Novartis Investigative Site | Vienna | A-1090 | Austria |
| Novartis Investigative Site | Brussels | 1200 | Belgium |
| Novartis Investigative Site | Laken | 1020 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Curitiba | Paraná | 80250-030 | Brazil |
| Novartis Investigative Site | Rio de Janeiro | Rio de Janeiro | 21941-912 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 05403-000 | Brazil |
| Novartis Investigative Site | Vancouver | British Colombia | V6H 3V4 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5G 1X8 | Canada |
| Novartis Investigative Site | Bron | 69677 | France |
| Novartis Investigative Site | Le Kremlin-Bicêtre | 94275 | France |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Sankt Augustin | North Rhine-Westphalia | 53757 | Germany |
| Novartis Investigative Site | Berlin | 13125 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Giessen | 35392 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Hamburg | 22081 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Budapest | 1023 | Hungary |
| Novartis Investigative Site | Budapest | 1094 | Hungary |
| Novartis Investigative Site | Haifa | 3525408 | Israel |
| Novartis Investigative Site | Jerusalem | 91031 | Israel |
| Novartis Investigative Site | Kfar Saba | 4428164 | Israel |
| Novartis Investigative Site | Petah Tikva | 49202 | Israel |
| Novartis Investigative Site | Ramat Gan | 5265601 | Israel |
| Novartis Investigative Site | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Genova | GE | 16147 | Italy |
| Novartis Investigative Site | Milan | MI | 20100 | Italy |
| Novartis Investigative Site | Roma | RM | 00165 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Utrecht | 3584 EA | Netherlands |
| Novartis Investigative Site | Warsaw | 02637 | Poland |
| Novartis Investigative Site | Moscow | 119991 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194100 | Russia |
| Novartis Investigative Site | Málaga | Andalusia | 29011 | Spain |
| Novartis Investigative Site | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46026 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Madrid | 28046 | Spain |
| Novartis Investigative Site | Stockholm | 17176 | Sweden |
| Novartis Investigative Site | Istanbul | TUR | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34722 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35340 | Turkey (Türkiye) |
Participants who at screening were aged ≥ 2 to < 20 years, had active SJIA (as per protocol), and were canakinumab treatment-naïve |
| FG002 | Dose Reduction | canakinumab 4 mg/kg every 4 weeks until study end unless discontinuation occurred, or until they qualified & entered Part II |
| FG003 | Dose Interval Prolongation | canakinumab 4 mg/kg every 4 weeks until study end unless discontinuation occurred, or until they qualified & entered Part II |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part 2 |
|
|
Safety Set
All patients who received at least one dose of study drug in Cohort 1 (resp. in Cohort 2) and had at least one post-treatment safety assessment in Part I before the canakinumab dose reduction/interval prolongation part. Of note, the statement that a patient had no adverse events (AE) also constituted a safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants from study CACZ885G2301E1, aged ≥ 2 to < 20 years at the time of the patient's first dose of canakinumab, who at the time of evaluation for participation in CACZ885G2306 were being treated with canakinumab 4mg/kg and had inactive disease |
| BG001 | Cohort 2 | Dose interval prologation All participants received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of this study All participants in Part II of this study came from Part 1, So only Part 1 is shown here in Baseline Characteristics |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Safety Set | Mean | Standard Deviation | Years |
| ||||||||||||||
| Age, Customized | Safety Set | Number | participants |
| |||||||||||||||
| Sex: Female, Male | Safety Set | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | 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 | Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. | The primary efficacy variable for Part II was the proportion of patients in clinical remission on canakinumab 4 mg/kg (+/- concomitant NSAID only) who were able to remain on a reduced dose or on prolonged dose interval for at least 24 consecutive weeks. As the primary objective was to show statistically significance in at least one of canakinumab treatment arms (reduced dose and prolonged dose interval arms) in Part II then the Type I error rate 5% was controlled and split to 2.5%. Clinical remission per protocol is defined as the maintenance of inactive disease for at least 6 months (24consecutive weeks) while on therapy. The primary analysis considered both inactive disease status and the patient dose step duration. In the event the inactive disease status was missing, yet the patient remained at the same dose level through the next visit with the same disease status, it was concluded that inactive disease was maintained during this time period and was carried forward. | Full Analysis Set | Posted | Number | particiapants | baseline to 24 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 | AEs, Deaths, other serious adverse events or discontinuations due to AE, Part I (Safety set) | Safety Set | Posted | Number | number of participants | During study parts I and II. The estimated study duration is not more than 216 weeks (with an average expected duration of 108 weeks). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 2 | AEs, Deaths, other serious adverse events or discontinuations due to AE, Part II (Safety set) | Safety Set | Posted | Number | number of participants | During study parts I and II, estimated study duration was not more than 216 weeks (with an average duration of 108 weeks). |
|
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to estimated study duration of not more than 216 weeks (with an average duration of 108 weeks)
Arms/Groups are combined because a threshold of 5% indicates that all Other (Not Including Serious) Adverse Events with a frequency greater than 5% within at least one arm or comparison group are reported.
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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 | Part I | Part I | 0 | 166 | 33 | 166 | 140 | 166 |
| EG001 | Part II@Dose Reduction | Part II@Dose reduction | 0 | 38 | 4 | 38 | 38 | 38 |
| EG002 | Part II@Dose Interval@Prolongation | Part II@Dose interval@prolongation | 0 | 37 | 1 | 37 | 34 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Still's disease | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Idiopathic intracranial hypertension | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Alveolar proteinosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash scarlatiniform | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (20.1) | 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 (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Office | Novartis Pharmaceuticals | +1 (862) 778-8300 | Novartis.email@novartis.com |
| 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 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C541220 | canakinumab |
Not provided
Not provided
Not provided
| Adverse Event |
|
| Lost to Follow-up |
|
|
| >=4 - <6 years |
|
|
| >=6 - <12 years |
|
|
| >=12 - <20 years |
|
|
| >=20 years |
|
|
|
|
| Not able to remain on dose |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|