Overview

This trial is active, not recruiting.

Condition systemic juvenile idiopathic arthritis
Treatment canakinumab
Phase phase 4
Sponsor Novartis Pharmaceuticals
Start date November 2014
End date December 2016
Trial size 11 participants
Trial identifier NCT02334748, CACZ885GFR01

Summary

The objective of this extension protocol is to collect safety data and to provide continuous Ilaris® (canakinumab) to patients in France who completed study CACZ885G2301E1 for a maximum of 24 months or until a decision regarding reimbursement in France is effective for Ilaris® in the SJIA indication.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will continue the same dose as their last dose administered in the study CACZ885G2301E1: canakinumab 4mg/kg (or 300mg max) or 2mg/kg (150mg/max) every 4 weeks. 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

Male or female participants of any age.

Inclusion Criteria: - Patients who have completed the international CACZ885G2301E1 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 With Systemic Juvenile Idiopathic Arthritis (SJIA) Who Participated in the International Phase III Study CACZ885G2301E1
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Novartis.