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. — ß-SPECIFIC 3

Systemic Juvenile Idiopathic Arthritis Clinical Trial

Official title:
An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever

Status Completed

Clinical Trial Summary

This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Arthritis
Arthritis, Juvenile
Systemic Juvenile Idiopathic Arthritis

Clinical Trial Details

NCT number	NCT00891046
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 3
Start date	September 2009
Completion date	December 2014

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT02334748` - A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies	Phase 3
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
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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
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