Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02334748 |
Date of registration:
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23/12/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
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Scientific title:
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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:
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November 3, 2014 |
Target sample size:
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31 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02334748 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Novartis Pharmaceuticals |
Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Hereditary Periodic Fevers
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Systemic Juvenile Idiopathic Arthritis
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Intervention(s)
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Drug: canakinumab
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Primary Outcome(s)
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All-cause Mortality
[Time Frame: uo to 1 year]
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Number of Participants With Adverse Events
[Time Frame: every 4 weeks up to 1 year]
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Secondary ID(s)
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CACZ885GFR01
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2014-002872-95
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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