Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Wounds and Injuries

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Blood and Lymph Conditions

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Rare Diseases

Syndrome

Inflammation

Necrosis

Arthritis

Arthritis, Rheumatoid

Arthritis, Juvenile

Hyperthermia

Pain

Respiratory Tract Infections

Fever

Arthralgia

Brucellosis

Familial Mediterranean Fever

Hereditary Autoinflammatory Diseases

Hypergammaglobulinemia

Amyloidosis

Joint Diseases

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Autoimmune Diseases

Genetic Diseases, Inborn

Proteostasis Deficiencies

Metabolic Diseases

Skin Diseases

Skin Diseases, Genetic

Chronic Graft Versus Host Disease

Systemic Onset Juvenile Idiopathic Arthritis

Familial Cold Autoinflammatory Syndrome

Muckle-Wells Syndrome

Wells Syndrome

Hyper-IgD Syndrome

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.

canakinumab

Novartis Pharmaceuticals

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.

A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies

A French Open-label Extension Study of Canakinumab in Patients Who Participated in International Phase III Studies CACZ885G2301E1 or CACZ885G2306 in Systemic Juvenile Idiopathic Arthritis and CACZ885N2301 in Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF)

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

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.

Number of participants who died for any reason during the study

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

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.

Canakinumab (ACZ885)

Canakinumab

Age, Continuous

Sex: Female, Male

Caucasian

Other

Race/Ethnicity, Customized

Study Director

Serious adverse events

Treatment emergent adverse events

Patients continued 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.

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.

Number of Participants With Adverse Events

All-cause Mortality

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.

Overall Study

Spots Global Cancer Trial Database for A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial