An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations.
Summary
This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis who previously were responsive to treatment with canakinumab to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or until October, 2012. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Systemic Juvenile Idiopathic Arthritis
Intervention
Canakinumab
Location
Arkansas Children's Hospital Research Inst
Little Rock
Arkansas
United States
72202
Status
Recruiting
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00891046
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Macrophage Activation Syndrome
A serious complication of childhood systemic inflammatory disorders that is thought to be caused by excessive activation and proliferation of T-LYMPHOCYTES and MACROPHAGES. It is seen predominantly in children with systemic onset JUVENILE IDIOPATHIC ARTHRITIS.
Arthritis, Juvenile Rheumatoid
Rheumatoid arthritis of children occurring in three major subtypes defined by the symptoms present during the first six months following onset: systemic-onset (Still's Disease, Juvenile-Onset), polyarticular-onset, and pauciarticular-onset. Adult-onset cases of Still's disease (STILL'S DISEASE, ADULT-ONSET) are also known. Only one subtype of juvenile rheumatoid arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.
Chloroquine
The prototypical antimalarial agent with a mechanism that is not well understood. It has also been used to treat rheumatoid arthritis, systemic lupus erythematosus, and in the systemic therapy of amebic liver abscesses.
Still's Disease, Adult-onset
Systemic-onset rheumatoid arthritis in adults. It differs from classical rheumatoid arthritis in that it is more often marked by acute febrile onset, and generalized lymphadenopathy and hepatosplenomegaly are more prominent.
Hyalinosis, Systemic
Autosomal recessive disorder characterized by HYALINE deposition in the skin, bone, gastrointestinal tract, muscles and glands; multiple subcutaneous skin nodules; GINGIVAL HYPERTROPHY; and joint CONTRACTURES. It is comprised of two allelic disorders: infantile systemic hyalinosis and juvenile hyaline fibromatosis. Mutations in the capillary morphogenesis protein-2 are associated with the disorder.
Clinical Trials
This study will assess the initial efficacy and safety of canakinumab over a 4 week period in patients with SJIA having a flare. Response to treatment will be according to the adapted ACR...
This two-part study will assess the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.
A Study of Tocilizumab in Patients With Active Systemic Juvenile Idiopathic Arthritis
This study will evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and...
Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis
The purpose of this study is to see if tocilizumab is safe and effective for treating systemic onset Juvenile Idiopathic Arthritis (soJIA). Another purpose is to see if tocilizumab helps r...
Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.
PubMed Articles
Arthritis in children represents a diagnostic and therapeutic challenge. The diagnostic spectrum is broad and a very precise indication for diagnostic and therapeutic procedures, especially in small c...
To examine the safety and efficacy of the interleukin-1 (IL-1) receptor antagonist anakinra as first-line therapy for systemic juvenile idiopathic arthritis (JIA).
Canakinumab in pediatric rheumatic diseases.
Introduction: Hitherto, some of the most severe forms of arthritis with onset in the neonatal period and early childhood have been resistant to conventional and anti-tumour necrosis factor agents. Rec...
The cryopyrin-associated periodic syndromes (CAPS) are a group of rare inherited inflammatory diseases associated with overproduction of IL-1β. Canakinumab, developed by Novartis AG (Basel, Switzerla...
The association between nephrotic syndrome and juvenile idiopathic arthritis have rarely been described in pediatric patients. We report a child with steroid-responsive nephrotic syndrome, with freque...
