Systemic Juvenile Idiopathic Arthritis (SJIA) with active systemic manifestations MedDRA version: 18.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor
Sponsors
Novartis Pharma S.A.S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this protocol have to fulfill all of the following criteria: 1. Patients who have completed the international ACZ885G2301E1 study without any significant safety issue and who have not enrolled into the international phase IIIb/IV study ACZ885G2306. 2. 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. Other criteria may apply Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.History of recurring infections, or underlying conditions which may predispose them to infections. Treatment with Ilaris should not be continued in patients with severe infections requiring medical intervention. 2.Hypersensitivity to the active substance or to any of the excipients. 3.Concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs will not be allowed with the exception of: •Methotrexate, and folic/folinic acid supplementation (according to standard medical practice) •Non-steroidal anti-inflammatory drug (NSAID) •Systemic corticosteroid treatment 4.concomitant use of another biologic agent or any investigational drug. 5.Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test or an urinary pregnancy test. 6.Female patients who are of child-bearing potential, defined as all females physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. ? Other criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this protocol is to add an extension period to provide continuous therapy and to collect safety data (collection of adverse events serious (SAE) or not (AE)) of French patients who completed the international CACZ885G2301E1 study in France.;Secondary Objective: ;Primary end point(s): | — |
Countries
France
Contacts
Public ContactInformation&communication médicales
Novartis Pharma S.A.S
Outcome results
None listed