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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-03

Study Completion Date

2017-01-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Periodic Fevers Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Canakinumab (ACZ885)

Participants continued the study drug based on the final dose and regimen administered at the end of the CACZ885N2301 study. All participants received 1 or 2 ACZ885 subcutaneous injections every 4 or 8 weeks.

Group Type EXPERIMENTAL

Canakinumab (AIN457)

Intervention Type BIOLOGICAL

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

Interventions

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Canakinumab (AIN457)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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