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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002872-95 | EudraCT Number |
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The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306 (NCT02296424) or CACZ885N2301 (NCT02059291) until a decision regarding reimbursement in France is effective for canakinumab (Ilaris®) in these indications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| canakinumab | Experimental | Patients will continue the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may be adjusted (or interrupted) according to the clinical response and to investigators judgment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| canakinumab | Drug | canakinumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | The objective of this protocol was to collect additional safety data (serious and non serious AEs) and to provide continuous Ilaris® (canakinumab) treatment to patients in France who completed CACZ885G2301E1, CACZ885N2301 or CACZ885G2306 studies. | every 4 weeks up to 1 year |
| All-cause Mortality | Number of participants who died for any reason during the study | uo to 1 year |
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Inclusion Criteria
Criteria applicable for patients with Systemic Juvenil Idiopathic Arthritis SJIA):
Patients who have completed the international studies CACZ885G2301E1 or CACZ885G2306 without any significant safety issue according to Investigator's opinion.
Patients who have completed the international CACZ885G2306 study and who successfully withdrew canakinumab treatment per protocol but with a disease relapse after the end of study visit will be allowed to participate in CACZ885GFR01 study (whatever the time of relapse from the end of study visit), if the investigator states that there is an indication to resume canakinumab.
Patients who have participated in the international CACZ885G2306 study but could not be randomized and then have continued canakinumab in part I until the end of the study at a dose of 4 mg/kg every 4 weeks may be switched to CACZ885GFR01 study if the investigator thinks that, in the interest of the patient, there is an indication to taper off canakinumab dose after a prolonged remission.
Criteria applicable for patients with HPF (TRAPS, HIDS, crFMF):
Patients who have completed the international CACZ885N2301 study without any significant safety issue according to Investigator's opinion.
Criteria applicable for all patients:
Parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's written informed consent for patients ≥ 18 years of age must be obtained before any study related activity or assessment is performed.
Exclusion Criteria:
other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bron | 69677 | France | |||
| Novartis Investigative Site |
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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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| ID | Title | Description |
|---|---|---|
| FG000 | Canakinumab | Patients continued same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose was 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigator's judgment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Dec 15, 2017 | Feb 20, 2019 |
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| Le Kremlin-Bicêtre |
| 94275 |
| France |
| Novartis Investigative Site | Paris | 75015 | France |
| COMPLETED | 23 |
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| NOT COMPLETED |
|
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All patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Canakinumab | Patients will continue the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may be adjusted (or interrupted) according to the clinical response and to investigators judgment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | 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 With Adverse Events | The objective of this protocol was to collect additional safety data (serious and non serious AEs) and to provide continuous Ilaris® (canakinumab) treatment to patients in France who completed CACZ885G2301E1, CACZ885N2301 or CACZ885G2306 studies. | Safety set: Safety set consisted of all patients who received at least one dose of study drug and had at least one post-treatment safety assessment in the study. | Posted | Count of Participants | Participants | every 4 weeks up to 1 year |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | All-cause Mortality | Number of participants who died for any reason during the study | Safety set | Posted | Count of Participants | Participants | uo to 1 year |
|
|
AEs and SAEs were collected for the maximum duration of treatment and follow up for a participant per protocol for approximately 12 months. All cause mortality (deaths) was collected from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) up to a maximum of 1 year
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of 1 year
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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 (ACZ885) | Patients continued the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may have been adjusted (or interrupted) according to the clinical response and to investigators judgment. | 0 | 31 | 7 | 31 | 28 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Histiocytosis haematophagic | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
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| 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 |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dermatitis allergic | 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 |
| |
| Rash | 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 the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharma AG | +1 (862) 778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2018 | Feb 20, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D018771 | Arthralgia |
| C565798 | Rheumatoid Arthritis, Systemic Juvenile |
| D054078 | Mevalonate Kinase Deficiency |
| D056587 | Cryopyrin-Associated Periodic Syndromes |
| 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 |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006942 | Hypergammaglobulinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008661 | Metabolism, Inborn Errors |
| D018901 | Peroxisomal Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007160 | Immunoproliferative Disorders |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D000094482 | Chronic Inducible Urticaria |
| D000080223 | Chronic Urticaria |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D000096703 | Cold Urticaria |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C541220 | canakinumab |
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