A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
Condition: Systemic Juvenile Idiopathic Arthritis; Hereditary Periodic Fevers
MeSH terms: Arthritis; Arthritis, Juvenile; Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases; Amyloidosis; Fever; Hyperthermia
Intervention: canakinumab
Intervention description: canakinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 5 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Juvenile Rheumatoid arthritis (JRA) chronic; systemic inflammatory disorder; painful joints; inflammation of the synovial membrane; auto-immune rheumatoid disease; reactive rheumatoid arthritis; Systemic Juvenile Rheumatoid arthritis (SJRA); Hereditary Periodic Fevers; Hereditary periodic fever syndrome(HPFS); Familial Mediterranean fever syndrome(FMFS); Hyperimmunoglobulinemia D; Tumor necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS); Muckle-Wells syndrome (MWS); Familial cold auto inflammatory syndrome

Summary:

      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.
    

Eligibility criteria:

        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