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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02334748
Date of registration: 23/12/2014
Prospective Registration: No
Primary sponsor: Novartis Pharmaceuticals
Public title: A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
Scientific 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)
Date of first enrolment: November 3, 2014
Target sample size: 31
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02334748
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
France
Contacts
Name:     Novartis Pharmaceuticals
Address: 
Telephone:
Email:
Affiliation:  Novartis Pharmaceuticals
Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: 20 Years
Gender: All
Health Condition(s) or Problem(s) studied
Hereditary Periodic Fevers
Systemic Juvenile Idiopathic Arthritis
Intervention(s)
Drug: canakinumab
Primary Outcome(s)
All-cause Mortality [Time Frame: uo to 1 year]
Number of Participants With Adverse Events [Time Frame: every 4 weeks up to 1 year]
Secondary Outcome(s)
Secondary ID(s)
CACZ885GFR01
2014-002872-95
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 19/05/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02334748
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