An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes

Novartis Pharmaceuticals4 enrolled

Overview

The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) 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 was suspended.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Periodic Fevers Syndrome

Interventions

Canakinumab (AIN457)BIOLOGICAL

Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 \< 20 years of age Exclusion Criteria: * Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study

Locations (3)

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Kyoto, Kyoto, Japan

Outcomes

Primary Outcomes

Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths

Participants were monitored for safety throughout the study.

Time frame: Participants were followed for the duration until approval, an expected average of 3 months.

Data from ClinicalTrials.gov

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