Clinical trial NCT02334748: A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Systemic Juvenile Idiopathic Arthritis
Hereditary Periodic Fevers
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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-01-08
Enrollment: 31
Sex: ALL
Minimum age (years): 5
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: every 4 weeks up to 1 year
measure: All-cause Mortality
timeFrame: uo to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bron Cedex
country: France
facility: Novartis Investigative Site
city: Le Kremlin Bicetre
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: