An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes

Phase 1

Active, not recruiting

Conditions: 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: 20.0Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2017-001678-40-Outside-EU/EEA

Lead Sponsor: ovartis pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active

Sex: All

Target Recruitment: 4

Inclusion Criteria

Key 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 < 20 years of age

Are the trial subjects under 18? yes
Number of subjects for this age range: 1
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

Key Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>Outcome Measure Description: To evaluate the safety and tolerability of canakinumab<br>;Timepoint(s) of evaluation of this end point: Timeframe: Participants will be followed for the duration until approval, an expected average of 3 months.<br><br>Outcome Measure Description: To evaluate the safety and tolerability of canakinumab<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Participants will be followed for the duration until approval, an expected average of 3 months.<br><br>Outcome Measure Description: To evaluate the safety and tolerability of canakinumab<br>;Timepoint(s) of evaluation of this end point: Participants will be followed for the duration until approval, an expected average of 3 months.<br><br>Outcome Measure Description: To evaluate the safety and tolerability of canakinumab<br>