Three disease of periodic fever syndromes, TNF receptor Associated Periodic Syndrome (TRAPS), Hyper IgDSyndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF MedDRA version: 20.0 Level: SOC Classification code 10010331 Term: Congenital, familial and genetic disorders System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Ilaris
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg/kg milligram(s)/kilogram
Con
Sponsors
Novartis pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion criteria: Completed Epoch 4 of the CACZ885N2301 study in Japan before the approval of canakinumab in Japan. Written informed consent. Parent or legal guardian's written informed consent and child's assent, if appropriate, are required before any assessment is performed for patients =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Key Exclusion criteria: Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offers the opportunity for patients who completed Epoch 4 of the preceding CACZ885N2301 study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes is suspended.;Secondary Objective: Not Applicable;Primary end point(s): Timeframe: Participants will be followed for the duration until approval, an expected average of 3 months. Outcome Measure Description: To evaluate the safety and tolerability of canakinumab ;Timepoint(s) of evaluation of this end point: Timeframe: Participants will be followed for the duration until approval, an expected average of 3 months. Outcome Measure Description: To evaluate the safety and tolerability of canakinumab | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Participants will be followed for the duration until approval, an expected average of 3 months. Outcome Measure Description: To evaluate the safety and tolerability of canakinumab ;Timepoint(s) of evaluation of this end point: Participants will be followed for the duration until approval, an expected average of 3 months. Outcome Measure Description: To evaluate the safety and tolerability of canakinumab | — |
Countries
Japan
Contacts
Public ContactClinical trial Information Desk
Novartis pharma AG
Outcome results
None listed