Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02334748
Other study ID # CACZ885GFR01
Secondary ID 2014-002872-95
Status Completed
Phase Phase 3
First received
Last updated
Start date November 3, 2014
Est. completion date August 31, 2018

Study information

Verified date May 2020
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date August 31, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 5 Years to 20 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
canakinumab
canakinumab

Locations

Country Name City State
France Novartis Investigative Site Bron Cedex
France Novartis Investigative Site Le Kremlin Bicetre
France Novartis Investigative Site Paris

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events 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. every 4 weeks up to 1 year
Primary All-cause Mortality Number of participants who died for any reason during the study uo to 1 year
See also
  Status Clinical Trial Phase
Completed NCT00891046 - An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever. Phase 3
Completed NCT01304420 - Ultrasonography in Juvenile Idiopathic Arthritis Phase 0
Completed NCT01803321 - Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA) Phase 1
Completed NCT00144664 - Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA) Phase 3
Completed NCT02396212 - Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA Phase 3
Completed NCT00144599 - Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA) Phase 3
Terminated NCT00886769 - Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) Phase 3
Completed NCT00144612 - Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA) Phase 3
Withdrawn NCT01676948 - An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) Phase 3
Recruiting NCT04088396 - A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA) Phase 3
Recruiting NCT05027373 - Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection Phase 1