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

November 30, 2017 updated by: Novartis Pharmaceuticals

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))

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Fukuoka
      • Fukuoka city, Fukuoka, Japan, 812-8582
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama-city, Kanagawa, Japan, 236-0004
        • Novartis Investigative Site
    • Kyoto
      • Kyoto-city, Kyoto, Japan, 606-8507
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Canakinumab (AIN457)
Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants were followed for the duration until approval, an expected average of 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2016

Primary Completion (Actual)

January 27, 2017

Study Completion (Actual)

January 27, 2017

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CACZ885N2301E2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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