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

Conditions

• Periodic Fevers Syndrome

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Canakinumab (AIN457) — BIOLOGICAL
  Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution

Study Details

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.

Key Dates

Start date

Oct 3, 2016

Status verified

Nov 2017

Primary completion

Jan 27, 2017

Completion

Jan 27, 2017

Study Design

Enrollment

4 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 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.

Primary Outcome Measure

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. ]