CompletedPhase 3

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

Japan4 participantsStarted 2016-10-03

Plain-language summary

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.

Who can participate

SexALL

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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 Exclusion Criteria: * Any conditions or significant medical problems in which the investigator judges the patient should not enter this extension study

What they're measuring

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

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

Trial details

NCT IDNCT02911857

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-01-27

Results submitted2017-07-25

View on ClinicalTrials.gov More Periodic Fevers Syndrome trials