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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Systemic Juvenile Idiopathic Arthritis Arthralgia Arthritis Arthritis, Juvenile Autoimmune Diseases Blood Protein Disorders Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Central Nervous System Diseases Chronic Disease Chronic Inducible Urticaria Chronic Urticaria Cold Urticaria Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cryopyrin-Associated Periodic Syndromes Disease Attributes Genetic Diseases, Inborn Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Hereditary Autoinflammatory Diseases Hereditary Periodic Fevers Hypergammaglobulinemia Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunoproliferative Disorders Joint Diseases Lung Diseases Lung Diseases, Obstructive Metabolic Diseases Metabolism, Inborn Errors Mevalonate Kinase Deficiency Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Organizing Pneumonia Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peroxisomal Disorders Respiratory Tract Diseases Rheumatic Diseases Rheumatoid Arthritis, Systemic Juvenile Signs and Symptoms Skin Diseases Skin Diseases, Genetic Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Bron, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

History of recurring infections
Hypersensitivity to the active substance or to any of the excipients

other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Canakinumab

Drug

canakinumab

Primary outcomes

Number of Participants With Adverse Events

Time frame: every 4 weeks up to 1 year

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.
All-cause Mortality

Time frame: uo to 1 year

Number of participants who died for any reason during the study

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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)

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Jan 8, 2015
Registry last updated: May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed