Back to resultsAn Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
Primary Purpose
Periodic Fevers Syndrome
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Canakinumab (AIN457)
Sponsored by
About this trial
This is an interventional treatment trial for Periodic Fevers Syndrome focused on measuring Canakinumab,, interleukin-1, Periodic Fevers Syndrome, TRAPS, HIDS, crFMF, auto-inflammatory diseases, extension study
Eligibility Criteria
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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Canakinumab (ACZ885)
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths
Participants were monitored for safety throughout the study.
Secondary Outcome Measures
Full Information
NCT ID
NCT02911857
First Posted
September 20, 2016
Last Updated
November 30, 2017
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02911857
Brief Title
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
Official 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))
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
January 27, 2017 (Actual)
Study Completion Date
January 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodic Fevers Syndrome
Keywords
Canakinumab,, interleukin-1, Periodic Fevers Syndrome, TRAPS, HIDS, crFMF, auto-inflammatory diseases, extension study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canakinumab (ACZ885)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Canakinumab (AIN457)
Intervention Description
Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution
Primary Outcome Measure Information:
Title
Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths
Description
Participants were monitored for safety throughout the study.
Time Frame
Participants were followed for the duration until approval, an expected average of 3 months.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Novartis Investigative Site
City
Fukuoka city
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Novartis Investigative Site
City
Yokohama-city
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Novartis Investigative Site
City
Kyoto-city
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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
Learn more about this trial
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
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