Overview

Conditions systemic juvenile idiopathic arthritis, hereditary periodic fevers
Treatment canakinumab
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date November 2014
End date December 2018
Trial size 41 participants
Trial identifier NCT02334748, CACZ885GFR01

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, CACZ885G2306 or CACZ885N2301 until a decision regarding reimbursement in France is effective for canakinumab (Ilaris®) in these indications.

Recruiting in the following locations…

United States No locations recruiting
Other countries France

Study Design

Allocation non-randomized
Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Patients will continue the same dose as their last dose administered in the study CACZ885G2301E1, CACZ885N2301 or CACZ885G2306. For all indications, the maximum canakinumab dose is 4 mg/kg or 300 mg for patients ≥ 40 kg. Ilaris® dosage may be adjusted (or interrupted) according to the clinical response and to investigators judgment.
canakinumab
canakinumab

Primary Outcomes

Measure
adverse events
time frame: every 4 weeks up to 1 year

Eligibility Criteria

All participants of any age.

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 within one year from withdrawal will be allowed to participate in CACZ885GFR01 study. 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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Novartis.