Completed

NCT Number: NCT02911857

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

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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Key information

Conditions

Periodic Fevers Syndrome

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Fukuoka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canakinumab (AIN457)

Biological

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

Primary outcomes

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

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

Participants were monitored for safety throughout the study.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Extension Study of CACZ885N2301 (NCT02059291), Multi-center, Open Label Study of Canakinumab in Japanese Patients With Periodic Fever Syndromes (Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyper Immunoglobulin D Syndrome ((Also Known as Mevalonate Kinase Deficiency) (HIDS/MKD), or Colchicine Resistant/Intolerant Familial Mediterranean Fever (crFMF))

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 22, 2016
Registry last updated: Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.